title: Early endoscopic intervention versus early conservative management in patients with acute gallstone pancreatitis and biliopancreatic obstruction: a randomized clinical trial.
abstract: OBJECTIVE
  To test the hypothesis that early endoscopic intervention, performed on patients with acute gallstone pancreatitis and biliopancreatic obstruction, reduces systemic and local inflammation.
  
  
  BACKGROUND
  The role of early endoscopic intervention, in the treatment of acute gallstone pancreatitis, remains controversial. Previous randomized trials have not focused on the subgroup of patients with clinical evidence of biliopancreatic obstruction.
  
  
  METHODS
  This single-center randomized clinical trial was performed between May 2000 and September 2005. Of 238 patients, admitted within 48 hours after the onset of acute gallstone pancreatitis, 103 with a distal bile duct measuring > or =8 mm combined with a total serum bilirubin > or =1.20 mg/dL, were randomized to receive either endoscopic retrograde cholangiopancreatography followed by endoscopic papillotomy for bile duct stones (EEI, n = 51) or early conservative management (ECM, n = 52). Patients with clinical evidence of coexisting acute cholangitis were excluded. Outcome measures included changes in organ failure score and computed tomography (CT) severity index during the first week after admission, incidence of local complications, and overall morbidity and mortality.
  
  
  RESULTS
  The incidence of bile duct stones at EEI was 72% and 40% of patients in the ECM group had persisting bile duct stones at elective biliary surgery. No significant differences were found between the EEI and ECM groups regarding changes in mean organ failure score (P = 0.87), mean CT severity index (P = 0.88), incidence of local complications (6% vs. 6%, P = 0.99), overall morbidity (21% vs. 18%, P = 0.80), and mortality (6% vs. 2%, P = 1).
  
  
  CONCLUSIONS
  The present study failed to provide evidence that early endoscopic intervention reduces systemic and local inflammation in patients with acute gallstone pancreatitis and biliopancreatic obstruction. If acute cholangitis can be safely excluded, early endoscopic intervention is not mandatory and should not be considered a standard indication.
authors.affiliation: Surgical Division, University of Buenos Aires, Buenos Aires, Argentina. ocampoc@yahoo.com
authors.forename: Alejandro
authors.initials: A
authors.lastname: Oría
authors.forename: Daniel
authors.initials: D
authors.lastname: Cimmino
authors.forename: Carlos
authors.initials: C
authors.lastname: Ocampo
authors.forename: Walter
authors.initials: W
authors.lastname: Silva
authors.forename: Gustavo
authors.initials: G
authors.lastname: Kohan
authors.forename: Hugo
authors.initials: H
authors.lastname: Zandalazini
authors.forename: Carlos
authors.initials: C
authors.lastname: Szelagowski
authors.forename: Luis
authors.initials: L
authors.lastname: Chiappetta
mesh_terms: D018806:APACHE; D000328:Adult; D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002779:Cholestasis / Q000000981:diagnostic imaging / Q000209:etiology / Q000601:surgery*; D005260:Female; D042882:Gallstones / Q000150:complications* / Q000000981:diagnostic imaging / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000000981:diagnostic imaging / Q000209:etiology / Q000601:surgery*; D016717:Sphincterotomy, Endoscopic; D013997:Time Factors; D016896:Treatment Outcome