Correspondence
Early ERCP and Papillotomy for Acute Biliary Pancreatitis
N Engl J Med 1997; 336:1835-1836June 19, 1997
- Article
To the Editor:
Fölsch et al. (Jan. 23 issue)1 concluded that in patients with acute biliary pancreatitis but without obstructive jaundice, early endoscopic retrograde cholangiopancreatography (ERCP) and papillotomy were not beneficial. Unfortunately, their report falls short of providing the necessary data to support this conclusion.
More specific information about the timing of ERCP is required. Acinar-cell injury occurs early (within hours) after pancreatic ductal obstruction in experimental studies of acute biliary pancreatitis.2 In the study by Fölsch et al., patients in the invasive-treatment group underwent ERCP within 72 hours after the onset of pain. What was the median delay (and the range) before ERCP was performed? Did the outcomes differ according to whether the intervention was performed very early (e.g., within 12 hours) or later?
Recent data have shown that ERCP is safer when performed by endoscopists who perform more than one sphincterotomy per week.3 At some centers, only a few patients were randomly assigned to a treatment group each year. Were the cases consecutive? What was the ERCP caseload (or another indicator of experience) for each participating endoscopist?
Patients in the intervention group actually underwent treatment (sphincterotomy) only when duct stones were seen on cholangiography (in 48 percent of the patients). How did the outcomes compare in the patients who underwent sphincterotomy and those who did not? Pancreatic ductal obstruction may also result from stenosis of the sphincter of Oddi caused by stone migration.4 Sphincterotomy to augment ductal drainage may be beneficial even in the absence of duct stones.5 By excluding patients with obvious biliary pancreatitis (bilirubin level, >5 mg per deciliter) and by not treating those with possible sphincter dysfunction, the investigators diluted any possible benefit of the approach they were investigating.
5 ReferencesPaul R. Tarnasky, M.D.
Peter B. Cotton, M.D.
Medical University of South Carolina, Charleston, SC 294251
Folsch UR, Nitsche R, Ludtke R, Hilgers RA, Creutzfeldt W, German Study Group on Acute Biliary Pancreatitis
Full Text | Web of Science | Medline2
Lerch MM ,Saluja AK ,Runzi M ,Dawra R ,Saluja M ,Steer ML . Pancreatic duct obstruction triggers acute necrotizing pancreatitis in the opossum. Gastroenterology 1993;104:853-861
Web of Science | Medline3
Freeman ML ,Nelson DB ,Sherman S , et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996;335:909-918
Full Text | Web of Science | Medline4
Hernandez CA ,Lerch MM . Sphincter stenosis and gallstone migration through the biliary tract. Lancet 1993;341:1371-1373
CrossRef | Web of Science | Medline5
Neoptolemos JP ,Stonelake P ,Radley S . Endoscopic sphincterotomy for acute pancreatitis. Hepatogastroenterology 1993;40:550-555
Web of Science | Medline
To the Editor:
The study by Fölsch et al. was terminated after reaching less than 75 percent of the initially calculated sample size (380 patients). The authors report that when the trial was stopped, “10 of 126 patients in the invasive-treatment group (7.9 percent) and 4 of 112 in the conservative-treatment group (3.6 percent) had died of pancreatitis.” However, they later state that this difference in mortality was not statistically significant (P = 0.16) and do not indicate the exact circumstances that led to the termination of the study. Their results appear to confirm the feeling of many biliary endoscopists that early ERCP with papillotomy, with few exceptions, is not beneficial in patients with acute biliary pancreatitis. However, the study lacks sufficient statistical power by a substantial margin and therefore does not allow this conclusion to be drawn.
Klaus Mergener, M.D.
Duke University Medical Center, Durham, NC 27705Author/Editor Response
The authors reply:
To the Editor: The study was terminated after reaching a sample size that was less than 75 percent of the initially calculated size. At that time, 10 of 126 patients in the invasive-treatment group (7.9 percent) and 4 of 112 patients in the conservative-treatment group (3.6 percent) had died from pancreatitis. The trial was stopped because the primary goal was to establish the superiority of the invasive treatment, not vice versa. Therefore, the concept and results of the study justified the conclusion that patients who have acute biliary pancreatitis without biliary obstruction or biliary sepsis do not benefit from immediate endoscopic interventions.
We agree with Tarnasky and Cotton that it is mandatory to investigate any possible therapeutic intervention as early as possible after pancreatitis begins.1 This was the reason we stipulated that the endoscopic intervention had to be performed within 72 hours after the beginning of abdominal pain, in contrast to the timing in other randomized trials.2,3 Twelve hours after the onset of abdominal pain, 10 of 126 patients (7.9 percent) underwent ERCP. This number increased on average by 7 percent per six-hour interval. The median delay before performing ERCP was 36 hours. The number of patients studied within 12 hours after the onset of pain was too small for a sound statistical evaluation.
We are aware of the published data that relate the safety of ERCP to the number of procedures performed per week.4 It is difficult for us to say precisely whether all the participating centers were high-volume centers, since we did not obtain data on the exact number of ERCPs performed per year at each center. But the participating physicians were selected because they were well-known endoscopists. Their experience is reflected by the high success rate of ERCPs (96 percent) and the low complication rate.
The enrollment of patients was consecutive. Some centers dropped out of the study before it officially closed, and others entered the study late. These facts, as well as the strict inclusion criteria, explain the somewhat low number of enrolled patients in some centers.
We did not consider comparing patients in the invasive-treatment group who underwent sphincterotomy with those who did not, since this was not the goal of the study. It is possible but purely speculative that endoscopic sphincterotomy may be beneficial in some patients with suspected pancreatic-duct obstruction.
4 ReferencesUlrich R. Fölsch, M.D.
Rolf Nitsche, M.D.
I. Medizinische Universitätsklinik, D-24105 Kiel, Germanyfor the German Study Group on Acute Biliary Pancreatitis
1
Lerch MM ,Saluja AK ,Runzi M ,Dawra R ,Saluja M ,Steer ML . Pancreatic duct obstruction triggers acute necrotizing pancreatitis in the opossum. Gastroenterology 1993;104:853-861
Web of Science | Medline2
Neoptolemos JP ,Carr-Locke DL ,London NJ ,Bailey IA ,James D ,Fossard DP . Controlled trial of urgent endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy versus conservative treatment for acute pancreatitis due to gallstones. Lancet 1988;2:979-983
CrossRef | Web of Science | Medline3
Fan S-T ,Lai ECS ,Mok FPT ,Lo C-M ,Zheng S-S ,Wong J . Early treatment of acute biliary pancreatitis by endoscopic papillotomy. N Engl J Med 1993;328:228-232
Full Text | Web of Science | Medline4
Freeman ML ,Nelson DB ,Sherman S , et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996;335:909-918
Full Text | Web of Science | Medline
- Citing Articles (3)
Citing Articles
1
Enns, Baillie. (1999) Review article: the treatment of acute biliary pancreatitis. Alimentary Pharmacology and Therapeutics 13:11, 1379-1389
CrossRef2
Patrick R. Pfau, Michael L. Kochman. (1999) Endoscopic management of biliary tract disease. Current Opinion in Gastroenterology 15:5, 448
CrossRef3
(1998) Technology status evaluation: endoscopic pancreatic therapyUpdate May 1998. Gastrointestinal Endoscopy 48:6, 723-726
CrossRef
