State Consumer Disputes Redressal Commission
Mrs. Kaberi Bhattacharya vs Advanced Medicare & Research Institute ... on 27 July, 2009
State Consumer Disputes Redressal Commission
State Consumer Disputes Redressal
Commission
West Bengal
BHABANI BHAVAN
(GROUND FLOOR)
31, BELVEDERE ROAD,
ALIPORE
KOLKATA 700 027
S.C. CASE NO. : CC/08/3
DATE OF FILING :
08.01.2008 DATE OF FINAL ORDER:
27.07.2009
COMPLAINANT
Mrs. Kaberi Bhattacharya,
Wife of Late Milan Bhattacharya
of 1/76, Azadgarh Colony
(Midnapara Road)
Kolkata-700 040.
OPPOSITE PARTIES
1. Advanced Medicare & Research
Institute
(A Joint Sector with Govt. of West
Bengal)
P-4 & 5, C.I.T. Scheme LXXII,
Block A, Gariahat Road,
Kolkata-700 029.
2. The Medical Superintendent
Advanced Medicare & Research
Institute
(A Joint Sector with Govt. of West
Bengal)
P-4 & 5, C.I.T. Scheme LXXII,
Block A, Gariahat Road,
Kolkata-700 029.
3. The Director,
Advanced Medicare & Research
Institute
(A Joint Sector with Govt. of West
Bengal)
P-4 & 5, C.I.T. Scheme LXXII,
Block A, Gariahat Road,
Kolkata-700 029.
4. Dr. Dipankar Sarkar,
Advanced Medicare & Research
Institute
(A Joint Sector with Govt. of West
Bengal)
P-4 & 5, C.I.T. Scheme LXXII,
Block A, Gariahat Road,
Kolkata-700 029.
BEFORE : MEMBER : MR. P.K.CHATTOPADHYAY
MEMBER : MR. S.COARI
FOR THE PETITIONER / APPELLANT : Md. Taufique, Ld. Advocate
FOR THE RESPONDENT / O.P.S.:
Mr. P.K.Basu, Ld. Advocate (OP 1,2&3)
Mr.
R.K.Mukherjee, Ld. Advocate (OP 4)
: O R D E R :
MR.
P.K.CHATTOPADHYAY, LD. MEMBER This complaint U/S 17 of the Consumer Protection Act, 1986 alleging deficiency in service and/or unfair trade practice on part of the Ops while rendering medical service to the husband of the complainant, was instituted by Mrs. Kaberi Bhattacharya, W/o Late Milan Bhattacharya against the Ops namely, (1) Advanced Medicare & Research Institute, (2) The Medical Superintendent, Advanced Medicare & Research Institute, (3) The Director, Advanced Medicare & Research Institute and (4) Dr. Dipankar Sarkar, Advanced Medicare & Research Institute.
The complainants case was that the husband of her was suffering from some pain in the abdomen some time in the 3rd week of October, 2006 when he attended OPD of the OP-Hospital on 29.11.06. The complainant was advised to undergo certain investigations including USG of upper abdomen and accordingly he underwent such test when the USG report dt. 2.12.06 revealed normal study according to the radiologist of the OP No. 1.
Despite such normal report the late husband of the complainant was advised admission for ERCP sphincterotomy and accordingly he was admitted on 6.12.06 at the said institute. The Admission Note indicated that the patient was suffering from severe pain in right upper abdomen when he was sent for ERCP test without allowing the patient to settle down. However, the procedure was abandoned without completing the test when it was reported that CBD could not be done procedure abandoned. Alleging that Dr. Dipankar Sarkar while performing the ERCP test caused perforation of the Duodenum of the patient, it was stated that the notes indicate admission of this position with the following words, Possible Duodenal Perforation. This position was also claimed to be admitted by Dr. Dipankar Sarkar and Dr. Debasis Deb. Thereafter for reasons best known to the doctor(s) of the OP No. 1, the patient was advised operation and accordingly, open surgery of abdomen was done on 7.12.06, i.e. on the following day after admission of the husband of the complainant and that too without any observation as to what was found in ERCP test.
Then, the patient started suffering from various complications/problems and ultimately he died of such injury caused during ERCP test on 17.12.06. On the foregoing fact it was alleged that ERCP was advised without any necessity whatsoever and that the test was performed with undue haste and without allowing the patient to get ready and prepared for the said test when he had hardly any relief from pain as was being suffered by him. Stating that the investigation reports did not indicate that performance of ERCP was so urgently required it was stated that Dr. Dipankar Sarkar mishandled the patient and in the process ruptured the Duodenum resulting in further suffering. Complaining that the operating surgeon did not make any mention as to what was done after opening the abdomen of the patient or for what purpose exactly the operation was carried out and what was done during the operation or the outcome thereof, it was alleged that appropriate medical care of the patient was not taken while he was hospitalized. It was also pointed out that the patient developed septicemia while he was under the care of this institute and that he died only due to recklessness, deficiency in service and gross negligence on the part of the OP-Doctor and also due to lack of infrastructure of the OP No. 1 for handling the patient. Stating that the husband of the complainant was the sole bread-earner of the family consisting of the complainant and her two children it was further stated that the husband of the complainant was employed with the Anandabazar Group and was posted as a Senior Manager, Market Development drawing salary of Rs. 41,601/- per month. It was also submitted that on his unfortunate and untimely death the entire family has been rendered helpless and is in grave financial distress and even a communication from the complainant on her bereavement to Brig Dr. S.P.Purakayastha, President, AMRI Hospital, (2) Mr. Ravi Todi, Managing Director, Shrachi Securities Ltd. and (3) Mr. Dhiraj Agawal, Director, J.B.Marketing and Finance Ltd., all connected with the said hospital, remained unanswered, which went against all ethics and could only be construed to mean guilty conscience and malafide intention.
Thereafter a lawyers notice was sent by the complainant demanding compensation for an amount of Rs. 50,00,000/- to which the Ld. Advocate for the Ops sent a reply, but this was not found satisfactory so far queries of the complainant were concerned. Hence, this complaint case seeking compensation for an amount of Rs. 50,00,000/- and payment of cost assessed at Rs. 50,000/- and/or other remedies.
The OP Nos. 1, 2, 3 & 4 entered appearance and filed written versions. In their written version the OP Nos. 1, 2 & 3 stated inter alia that as per instruction of the treating doctor post consultation as Outdoor Patient the complainants husband underwent tests including USG of upper abdomen when the patient was earlier admitted in the said hospital with acute Pancreatitis and gall-stone disease. Even after removal of gall-stone the patient was having pain suggestive of Pancreatitis and in order to find the cause thereof it was imperative to do ERCP since the same was most specific and sensitive test for diagnosis of Pancreatic structure. This was deemed all the more necessary when USG test failed to offer proper diagnosis.
Additionally, ERCP test was also a mode of treatment of Pancreatic disease and the doctor had no other choice but to do ERCP even when some pain was subsisting as the test served dual purpose of diagnosis and treatment. Prior to undertaking ERCP, possible heath hazards and risks were discussed with the patient and post-ERCP when the patient was complaining of severe abdominal pain, Dr. Debasis Deb examined the patient and found that the patients bowel sounds were somewhat sluggish. Contemplating the possibility of duodenal perforation or reactivation of acute pancreatitis, abdominal CT scan with oral and TV cantrast was advised when CT scan did not show any pancreatic abnormality but a small perforation in the second part of the Duodenum with free air around Duodenum. So, a diagnosis of Paritoritis due to a duodenal perforation was made and a decision of emergent exploratory Laparotomy was taken on 7.12.06 after adequate resuscitations upon obtaining high risk consent. Dr. Dipankar Sarkar after examination of the patient suspected possible duodenal perforation and advised abdominal xray. Upon Laparotomy done on 7.12.06 a perforation in the second part of the Duodenum was seen and the same was repaired with vicryl and reinforced with serosal patch of a jejunal loop. A feeding jejunostomy was added and because of impending Abdominal Compartment Syndrome the abdomen was kept open by an Laparostomy. A tube drain was put in sub-hepatic area to drain if any fistula arises from Duodenum. The operative finding was made known to the patient party, specially to the wife of the patient, when it was clearly informed that biliary peritoritis was a serious disease and carried very high mortality.
The patient gradually improved and in subsequent days he was put off ventilator and on 11.11.06 he was taken back to O.T. to close Laparostomy and refashioning jejunostomy which was functioning suboptimally. Thereafter the patient remained stable albeit needed ventilator and feeding was continued through jejunostomy. During this period Dr. Debasis Deb visited the patient regularly and discussed the treatment plan with Dr. Dipankar Sarkar and Dr. S.K.Todi, the critical care in charge.
However, on 15.12.06 the condition of the patient suddenly deteriorated and during the visit of Dr. Deb the situation was made known to the patient party when Dr. Deb also recommended change of antibiotics to Meropenom and added artifungal as well. But it did not respond much and full blown ARDS, a sequele of sepsis and multiorgan failure set in causing death of the patient on 17.12.06. Stressing that ERCP test was just right for the patient when he was suffering from recurrent attacks of clinically suggestive Pancreatitis despite Cholecystectomy, it was argued that the timing of ERCP was 100% correct and Duodenum injury, if at all, was a known complication when high mortality rate in biliary peritonitis is a very well known feature. Thus, the OP Nos. 1, 2 & 3 at no point of time failed to diagnose the complications of the patient or made any attempt to hide and/or suppress the diagnosis of complications and meted out various treatments to the best of ability and in the process there was evidently no negligence or deficiency of service. Accordingly, the said Ops prayed for dismissal of the complaint.
The OP No. 4 namely, Dr. Dipankar Sarkar, in his written version denied and disputed the allegations and stated inter alia that the OP No. 4 being a qualified and highly experienced Gastroentereologist attempted for ERCP upon the patient after taking due care and caution and in order to help relief for the abdominal pain, he advised the patient for necessary medicines, I.V. Fluid etc. which were administered and applied and the pain subsided and only then ERCP was sought to be made after obtaining appropriate consent subsequent to proper explanation of the necessity, risks involved and procedure thereto. Accordant medical procedure was adopted to do ERCP step by step after administration of relevant medicines. But the procedure could not be completed in spite of best efforts as OP No. 4 did not succeed in cannlating the CBD and in consideration of safety of the patient the procedure was stopped, ERCP being an invasive and semi blind procedure. Denying that while performing ERCP, the OP No. 4 caused perforation of the Duodenum of the patient and/or rupturing the Duodenum of the patient or that admitted the same and also by Dr. Debasis Deb, it was contended that while it was a fact that ERCP procedure could not be completed due to technical reason, the suspected possible duodenum perforation was noted in the treatment document, and the patient had to undergo further operation and treatment by other doctors particularly by Dr. Debasis Deb, the surgeon and Dr. S.K.Todi, last two having been not made parties in this case. Stating that from the treatment document it would appear that on 6.12.06 the patient was shifted to ITU and the diagnosis of having intestinal/duodenal perforation by xray of his abdomen, the OP No. 4 referred the case to Dr. Deb when on 7.12.06 CT scan was done and for proper and better management Exploratory laparotomy was performed with closure of duodenum vent with feeding jejunostomy and the patient was put on ventilation. On 8.12.06 the patient was stable with diminishing pain and on 9.12.06 he started tolerating feed through jejunostomy and felt hungry which was a sign of recovery. On 10.12.06 he did not tolerate jejusmeal feeding and on 11.12.06 the patient was operated for second time by Dr. Debasis Deb and refashioning of feeding by jejunostomy was done. On 12.12.06 the patient was taken off ventilator after extubation when the patient was doing well and on 13.12.06 CVP monitoring was stopped as it was no longer required, but there was respiratory distress. On 14.12.06 jejunostomy feeding resumed and on 15.12.06 patients oxygen saturation reduced and he started having breathing difficulties being put on ventilator again. On 16.12.06 he developed ARDS and despite best of efforts and treatment the patient succumbed due to ARDS while remaining in ventilator and under constant medical care.
Therefore, the proximate cause of death of the patient was not for Duodenum perforation and not related to it, but ARDS. Disputing the allegations that ERCP was advised without any necessity or done in hasty manner not allowing the patient to have relief from pain or that the OP No. 4 mishandled the patient while performing ERCP or in the process perforated/ruptured the Duodenum, the OP No. 4 sought strict proof on the said allegations. Denying the allegations of negligence and/or deficiency in service on part of the OP No. 4 on the patient, prayer was made for dismissal of the complaint with exemplatory cost.
The matter was heard from respective sides with filing of evidence and WNA. In its WNA the complainant reiterated the case as in the petition of complaint and referred to a paper from Ohio State University Medical Centre wherein it was stated inter alia that ERCP is used primarily to diagnose and treat conditions of the bile ducts, including gallstones, inflammatory strictures (scars), leaks (from trauma and surgery), and cancer. ERCP can be performed for diagnostic and therapeutic reasons, although the development of safer and relatively non-infasive investigations such as Magnetic Resonance Cholangiopancreatography (MRCP) and endoscopic ultrasound has meant that ERCP is now rarely performed without therapeutic intent.
The same text clearly speaks about the contra indications of the said ERCP in the following terms :
1. Absolute contraindications:
the uncooperative patient.
2. Relative Contraindications :
a) Recent attack of acute pancreatitis, within the past several weeks.
b) Recent myocardial infarction.
c) Inadequate surgical back up.
Another paper relied upon by the complainant was an editorial by Maxim S.Petrov, Department of Surgery, Nizhny Novgorod State Medical Academy, Nizhny Novogorod, Russia, which made a clear distinction between the ERCP and MRCP and also in the use of the aforesaid two methods in patients suffering from acute pancreatitis and relying on the various authorities on the subject the author clearly wrote that ERCP should not be taken recourse to until and unless there was clear cut evidence of the obstruction in the duct and the said procedure should be taken only for the purpose of the removal of the said obstruction in the duct. The author also stated that the early use of ERCP should be avoided for the notorious nature of the procedure itself. The said text contained a table which showed clearly that without being sure about the source of the obstruction in the duct the doctor should not take recourse to ERCP.
The procedure of ERCP was criticized in the said text in the following words :
No doubt, if ERCP was a completely (or at last reasonably) harmless procedure, there would be no room for this editorial as well as dozens of clinical trials on the prevention of post ERCP complications. However, ERCP is one of the most challenging endoscopic procedures with a reported rate of procedure related complications of approximately 5-10%. Moreover, in some cases it may even lead to mortality. It is generally agreed that the main aim of ERCP in patients with acute biliary pancreatitis is to detect main bile duct stones; however, in fact, ERCP is capable of doing this in only 39-46% of cases. This means that at least one in two patients undergoes a futile endoscopic intervention. Furthermore, given that recent randomized and non-randomized studies demonstrated a 71-88% rate of spontaneous disobstruction within 48 hours after the onset of acute biliary pancreatitis (and subsequent uneventful course of acute pancreatitis) only a small sub group of the patients might, in fact, have a theoretical justification for undergoing ERCP. In addition, evolutionary pressure from competing technologies (endoscopic ultrasonograpy (EUS)) and MRCP has greatly challenged the need for diagnostic ERCP. This is evidenced by the results of a recent study from the U.S.A. which investigated trends in the utilization of ERCP since 1988. In a cohort of more than 400,000 patients, a steep rise was found in the usage of ERCP until 1996 whereas its utilization steadily feel afterwards (coincidentally or not, the first randomized controlled trial which underscored the lack of clinical benefits from ERCP was published at the same time in January 1997.
The author in the same text made following observations while concluding the need of MRCP over ERCP in the following words :
1. Indications for early ERCP should not be based on predicted severity, but rather on the duration of the biliopancreatic obstruction.
2. Given that the absence of transient biliopancreatic obstruction is associated with an uneventful course of acute biliary pancreatitis and taking into account that, in the majority of patients, main bile duct stones pass spontaneously into the duodenum, early biliary imaging is not required either in patients without biliopancreatic obstruction or those with transient obstruction.
3. In patients with a suspicion of persistent obstruction, EUS or MRCP is indicated. Persistent obstruction can be arbitrarily defined as one lasting for at least 48 hour. Further studies should define whether this period can be safely extended beyond this time point.
4. Early ERCP with biliary decompression is warranted only in patients with acute cholangitis and those with persistent obstruction.
Citations of the Honble Supreme Court in (i) AIR 1969 Supreme Court 128, (ii) (1998) 4 Supreme Court Cases 39, (iii) (1996) 2 Supreme Court Cases 634 and (iv) 2004 (8) Supreme Court 58 were also relied upon.
In the WNA filed by the OP Nos. 1, 2 & 3 the entire chain of events leading to the complaint were stated and then it was argued inter alia that in a case of medical negligence the party making a complaint was under obligation to allege as to which action of the doctor was not as per accepted medical practice and what was done should not have been done and what was not done should have been done, which was required to be duly supported by expert evidence or available medical text or treaty. Contending that the foregoing guideline/averment in terms of citation in 2004 CTJ 175 (NC), was not heeded to by the complainant it was further, arguing that no expert evidence was provided by the complainant and attention was drawn to judgements of the Honble National Commission in 2001 (3) CPR 172, 2007 (2) CPJ 235 to the effect that without expert evidence onus upon the complainant is not ordinarily discharged. Stating that Court cannot speculate upon medical matter or come to a conclusion or diagnosis which are not supported by the evidence of expert as was held in 1994 (1) CPJ 509 at Page-524, it was also contended that in terms of decision in 2005 CTJ 855 (NC), it is for the doctor to decide what type of treatment a patient is to be given and whether an operation be performed on him.
Arguing that the Consumer Forum/Commission could not assume the role of medical expert, without being so, the Commission could not adjudge charges levelled by a patient that the methods of treatment were wrong or faulty as decided in 2005 CTJ 922 (NC) and 2003 (1) CPJ 153 (NC). Stating that the entire treatment sheet/bed-head tickets were there where it would be evident that in spite of best possible and sincere efforts by the team of doctors and the hospital the patient unfortunately succumbed to ARDS on 17.12.06, it was contended that there was no counter-evidence before this Commission to point out that the doctor(s) or the hospital were at fault in providing right treatment to the patient and thus the complaint being devoid of any merit was liable to be dismissed with compensatory cost.
The OP No. 4 in his WNA argued that the complainant miserably failed to prove her case against the OP and the materials on record would reveal that the patient was suffering from a serious disease called Pancreatitis when his gall-bladder was removed three years back by Cholecystectomy when the complainant deliberately suppressed this position. Stating that due process and procedure was followed prior to and subsequent to undertaking the ERCP, it was claimed that the allegations relating to ERCP were all fabricated and not true. Stating that OP No. 4 took proper measure with best of his knowledge, skill and care in regard to treatment of the patient and then referring him to other senior doctors it was no doubt unfortunate that the patient died due to ARDS when the cause of death had no direct bearing either with ERCP procedure or with possible perforation as falsely alleged by the complainant, which in any case could not be substantiated by the complainant. Calling the grievances and allegations of the complainant as misconceived and concocted it was stated that a case of medical negligence could not be proved without expert medical evidence where the complainant could not adduce any tangible evidence or opinion of the expert which was clearly decided in citation in 2008 (3) WBLR (CPNC) 159.
DISCUSSION A) Admittedly the complainants husband, Late Milan Bhattacharya, was suffering from pain and other ailments relating to his abdomen when he was earlier treated for similar ailments and underwent Cholecystectomy. He had suffered from Pancreatitis too and was successfully treated by the OP No. 4, which event took place about three years back.
Subsequently when the patient, the husband of the complainant, had complained of severe pain in his right upper abdomen and epigastric region, he went to the OP No. 4 at the institute of the OP Nos. 1,2 & 3 for management and treatment of his ailment and was advised ERCP. The complainants case is that inspite of his immense suffering from severe pain the OP No. 4 recommended and conducted ERCP test without allowing the patient to settle down. It was also the case that given risk involvement and procedure was not adequately explained prior to the procedure and in the process Dr. Dipankar Sarkar, the OP No. 4, in course of conducting ERCP test caused perforation of the Duodenum of the patient and/or ruptured the Duodenum which supposedly was also admitted by the said doctor. Alleging that this and subsequent action on part of the OPs/Doctor(s) resulted in increasing suffering of the patient ultimately amounting to his sad demise, the complainant sought remedies in cost and compensation when even her first intimation letter to the Ops conveying her distress on the entire event remained unattended and not replied to. However, the complainant did not file any tangible evidence of any medical expert as to the allegations of medical negligence and/or deficiency of service on part of the Ops excepting filing of evidence by herself .
B) In the complaint and in other averments the complainant sought to convey that firstly the timing of ERCP was not proper as the procedure was contra-indicated when the patient had been suffering from severe pain in his abdomen and secondly, ERCP was not the only mode of investigation when other better options like MRCP, etc. were available. Other than this, there was no significant allegation on further course of treatment regimen undertaken by the Ops and other Doctors/Surgeons. In such regard the excerpts from medical journals were relied upon by the complainant wherein ERCP was stated to be -
This test is done to check the bile and pancreatic ducts coming from gallbladder and pancreas. The ERCP is done with a narrow, flexible tube that goes through the mouth into the upper digestive tract. It allows the doctor to look into esophagus, stomach and small intestine. Dye is then put into common bile duct and pancreatic duct and x-rays are taken. This test helps your doctor diagnose illness and plan treatment.
Indication for imaging Gallstones, which are trapped in the main bile duct Blockage of the bile duct Yellow jaundice, which turns the skin yellow and urine dark Undiagnosed upper-abdominal pain Cancer of the bile ducts or pancreas Pancreatitis (inflammation of the pancreas) The main symptoms of pancreatitis are acute, severe pain in the upper abdomen, frequently accompanied by vomiting and fever. The abdomen is tender, and the patient feels and looks ill. The diagnosis is made by measuring the blood pancreas enzymes which are elevated. A sound wave test (ultrasound) or abdominal CT exam often shows an enlarged pancreas. The condition is treated by resting the pancreas while the tissues heal.
This is accomplished through bowel rest, hospitalization, intravenous feeding and, pain medications.
When pancreatitis is caused by gallstones, it is necessary to remove the gallbladder. This is usually done after the acute pancreatitis has resolved. At times, an ERCP (Endoscopic Retrograde CholangioPancreatography) test is recommended. This involves passing a flexible tube through the mouth and down to the small intestine. A small catheter is then inserted into the bile duct to see if any stones are present. If so, they are then removed with the scope.
Side Effects and Risks A temporary, mild sore throat sometimes occurs after the exam. Serious risks with ERCP, however, are uncommon. One such risk is excessive bleeding, especially when electrocautery is used to open a blocked duct. In rare instances, a perforation or tear in the intestinal wall can occur.
Inflammation of the pancreas also can develop. These complications may require hospitalization and, rarely, surgery. There is also a small risk of an allergic reaction to the dye, which contains iodine. Rarely, drugs used to relax the ampulla of Vater can have side effects such as nausea, dry mouth, flushing, urinary retention, rapid heart rate (sinus or supraventricular tachycardia) or a drop in blood pressure.
************* There are many advantages of MRCP compared with previous imaging techniques. It does not require the use of contrast so avoiding the possibility of a reaction. In fact, safety is comparable to ultrasound providing the few contraindications are observed and since no radiation is used. No special patient preparation is required and the procedure is very rapid to perform.
When compared to ERCP or PTC the accuracy is very similar. MRCP has a sensitivity and specificity of 91% and 98% respectively for choledocholithiasis (1,2,3). Its accuracy for benign and malignant obstruction is 90%. Furthermore, it does not carry the 5-30% failure rate associated with ERCP(4). It is also spares the morbidity (1-7%) and mortality (0.2 1%) of ERCP (4,5) and is twice as cost effective(5).
The disadvantage is that it is solely a diagnostic test. For this reason it should not be used in choledocholithiasis when there is a high likelihood of a CBD stone. In this situation ERCP would be indicated since endobiliary therapy can also be carried out. MRCP is not the initial investigation of choice in cholecystitis as ultrasound is just as accurate and much mokre cost effective.
Source MRCP info From Royal College of Surgeons Edinburg website.
Time for Change No doubt, if ERCP was a completely (or at least reasonably) harmless procedure, there would be no room for this editorial as well as dozens of clinical trials on the prevention of post-ERCP complications. However, ERCP is one of the most challenging endoscopic procedures with a reported rate of procedure-related complications of approximately 5-10%. Moreover, in some cases it may even lead to mortality. It is generally agreed that the main aim of ERCP in patients with acute biliary pancreatitis is to detect main bile duct stones; however, in fact, ERCP is capable of doing this in only 39-46% of cases. This means that at least one in two patients undergoes a futile endoscopic intervention. Furthermore, given that recent randomized and non-randomized studies demonstrated a 71-88% rate of spontaneous disobstruction within 48 h after the onset of acute biliary pancreatitis (and subsequent uneventful course of acute pancreatitis), only a small subgroup of patients might, in fact, have a theoretical justification for undergoing ERCP. In addition, evolutionary pressure from competing technologies (endoscopic ultrasonography (EUS) and magnetic resonance cholangiopancreatography (MRCP) has greatly challenged the need for diagnostic ERCP. This is evidenced by the results of a recent study from the U.S.A. which investigated trends in the utilization of ERCP since 1988. In the cohort of more than 400,000 patients, a steep rise was found in the usage of ERCP until 1996 whereas its utilization steadily fell afterwards (coincidentally or not, the first randomized controlled trial which underscored the lack of clinical benefits from ERCP was published at the same time- in January 1997.
Conclusions
1. Indications for early ERCP should not be based on predicted severity, but rather on the duration of the biliopancreatic obstruction.
2. Given that the absence of transient biliopancreatic obstruction is associated with an uneventful course of acute biliary pancreatitis and taking into account that, in the majority of patients, main bile duct stones pass spontaneously into the duodenum, early biliary imaging is not required either in patients without biliopancreatic obstruction or those transient obstruction.
3. In patients with a suspicion of persistent obstruction, EUS or MRCP is indicated. Persistent obstruction can be arbitrarily defined as one lasting for at least 48 h. Further studies should define whether this period can be safely extended beyond this time point.
4. Early ERCP with biliary decompression is warranted only in patients with acute cholangitis and those with persistent obstruction.
Source Editorial by Maxim S Petrov, Department of Surgery, Nizhny Novgonord State Medical Academy, Russia.
The Ops position was that advice of spincterotomy ERCP was given as that was the only procedure which offered best diagnosis and treatment at the same go as per standard practice followed everywhere and this is laid down in medical texts for the purpose of management of the case of such kind of patient, like Magnetic Resonance Imaging There is limited information on magnetic resonance imaging (MRI) or magnetic resonance cholangiopancreatography (MRCP) in patients with chronic pancreatitis. A number of small studies suggest that MRCP provides an acceptable assessment of pancreatic ductal morphology in most patients.
MCRP results agree with ERCP results in 70% to 80% of cases, with the higher rates of agreement seen in studies using the most advanced image analysis techniques. Agreement between MRCP and ERCP is worse in areas where the pancreatic duct is small (tail of pancreas and side branches).
Advancements in MR image analysis will continue to improve the image quality of MRCP, which in the future could approach ERCP in accuracy. For the moment, however, ERCP has superior spatial resolution. Like ERCP, however, MRCP will be inaccurate in patients without significant ductal abnormalities. Although MRI is widely available, not all centers have the capacity to perform high-quality MRCP.
Several centers have investigated the use of functional MRCP by obtaining images after injection of secretin, when the pancreatic duct is more easily visible and the volume of pancreatic fluid entering the duodenum can be quantified providing, at least potentially, some measure of pancreatic secretory capacity. The overall accuracy of this technique remains to be determined.
Endoscopic Retrograde Cholangiopancreatography Pancreatography is generally considered the most specific and sensitive test of pancreatic structure and many consider it the de facto gold standard. It also has the advantage over all previously discussed tests in that therapy (e.g., pancreatic duct stenting or stone extraction) may be administered during its performance. The disadvantage, however, is that ERCP is the riskiest diagnostic test, with complications occurring in at least 5% of patients (in as many as 20% of certain subgroups) and a mortality rate of 0.1% to 0.5%. In most studies in patients with chronic pancreatitis, the sensitivity of ERCP is between 70% and 90%, with a specificity of 80% to 100%. Thus, chronic pancreatitis can exist in the absence of any visible changes within the pancreatic duct.
The disgnostic features of chronic pancreatitis on ERCP are listed in Table 57-4. The diagnosis is based on abnormalities seen in both the main pancreatic duct and the side branches. ERCP is highly sensitive and specific in patients with advanced disease. The appearance of a massively dilated pancreatic duct with alternating strictures (the chain-of-lakes appearance) is characteristic of the most advanced chronic pancreatitis. Less dramatic pancreatographic changes are less definitive and specific.
************* Complications We all hope and plan for our procedures to be successful, painless and uncomplicated but must recognize that some adverse outcomes are unavoidable. Positive outcomes are discussed in Chapter 12 and specific complications are discussed in relevant sections.
The word complication carries an unfortunate connotation; it suggests blame or malpractice. Some complications certainly arise from negligence, but the vast majority do not. This is the essence and importance of truly informed consent; the patient signs regarding potential benefits and risks ***************** ERCP is perhaps the most rewarding endoscopic procedure performed by gastroenterologists. It is also the most dangerous. Considering of its role involves careful balancing of its risks and benefits, with full knowledge of the alternative management methods, especially interventional radiology and surgery. Which technique to use is also influenced considerably by the stage of the disease (e.g. the extent of the tumour) and by the general health of patient.
Some general aspects of risks are covered in Chapter 3 and outcome definitions in Chapter 12.
Source Cambridge Text Pancreas, ERCP and Therapy Stating that after clearly explaining the risk involvement and procedure to the patient and his party, necessary medicines, I.V. drip etc. were administered and the process of ERCP was undertaken only after his pain subsided.
It was, however, a fact that in spite of application of methodical procedure and applications of relevant and other medicines the procedure of ERCP could not be completed as the OP No. 4 could not succeed in cannalating the CBD which was the first stage of ERCP sphincterotomy and for the safety of the patient the procedure had to be stopped when ERCP was an evasive and sem-blind procedure. Referring to the allegation of perforation of Duodenum of the complainants husband in course of the said procedure, the allegation was denied and only a suspicion of possible Duodenum perforation was noted subject to further investigation and treatment. The patient was thereafter referred to Dr. Debasis Deb and Dr. Todi a well, all of whom attended the patient and did their best. But it was a fact that the patient could not be saved.
Therefore, it will appear that the Ops took informed decision on medical treatment and procedure after due explanation thereof and with full consent, on which only they were competent and this Commission or for that matter none else other than the specialists can have any contrary view. In such regard, reliance was had on the decisions reported in 1994 (1) CPJ 509 Page-524 that Court cannot speculate upon medical matter or come to a conclusion or diagnosis which are not supported evidence of expert along with (i) Rajkumar Vishve Vs. Dr. Vandana Gupta & another (2007) 3 WBLR (CPNC) 695, (ii) Ajay Gupta Vs. Dr. Pradeep Aggarwal & others (2008) 3 WBLR (CPNC) 159, (iii) Sarangapani Vs. Bone & Joint Clinic (2008) 3 WBLR (CPNC) 942 and (iv) Mr. Mihir Banerjee Vs. Dr. Abhijit Roy (2009) 1 WBLR (CPSC) 847.
On careful examination of respective positions read with citations we agree with the stance of the Ops to the effect that this Commission cannot indeed assume the role of medical expert to decide which test would have been the best in the given condition/status of the patient and, therefore, without clinching medical evidence we are unable to fasten any ingredient of negligence and/or deficiency of service on the Ops.
C. Thus, having gone through the entire treatment sheets, bed-head ticket and relevant other papers with no plausible counter-evidence forthcoming before us to the effect that the doctor or the hospital were at fault at any stage in providing appropriate treatment to the patient and relying on the decision of the Honble National Consumer Disputes Redressal Commission in 2003 (10 CPJ 153 and 2009 (2) CPR 225 we cannot say that the doctor was not the appropriate person to decide the type of treatment which the patient was required to be given and the given operation/test was required to be performed by him or otherwise as decided in 2005 CTJ 855. In such view, the complaint is devoid of any merit and substance and hence, the same is liable to be dismissed on contest without cost.
O R D E R Accordingly, it is ORDERED that the complaint stands dismissed on contest without cost.
MEMBER MEMBER