title: Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial.
abstract: BACKGROUND
  Patients who undergo endoscopic sphincterotomy for common bile-duct stones, who have residual gallbladder stones, are referred for laparoscopic cholecystectomy. However, only 10% of patients who do not have this operation are reported to develop recurrent biliary symptoms. We aimed to assess whether a wait-and-see policy is justified.
  
  
  METHODS
  We did a prospective, randomised, multicentre trial in 120 patients (age 18-80 years) who underwent endoscopic sphincterotomy and stone extraction, with proven gallbladder stones. Patients were randomly allocated to wait and see (n=64) or laparoscopic cholecystectomy (56). Primary outcome was recurrence of at least one biliary event during 2-year follow-up, and secondary outcomes were complications of cholecystectomy and quality of life. Analysis was by intention to treat.
  
  
  RESULTS
  12 patients were lost to follow-up immediately. Of 59 patients allocated to wait and see, 27 (47%) had recurrent biliary symptoms compared with one (2%) of 49 patients after laparoscopic cholecystectomy (relative risk 22.42, 95% CI 3.16-159.14, p<0.0001). 22 (81%) of 27 patients underwent cholecystectomy, mainly for biliary pain (n=13) or acute cholecystitis (7). Conversion rate to open surgery was 55% in patients allocated to wait and see who underwent cholecystectomy compared with 23% in those who were allocated laparoscopic cholecystectomy (p=0.0104). Morbidity was 32% versus 14% (p=0.1048), and median hospital stay was 9 versus 7 days. Quality of life returned to normal within 3 months after either treatment policy.
  
  
  CONCLUSIONS
  A wait-and-see policy after endoscopic sphincterotomy in combined cholecystodocholithiasis cannot be recommended as standard treatment, since 47% of expectantly managed patients developed at least one recurrent biliary event and 37% needed cholecystectomy. No major biliary complications arose, but conversion rate was high.
authors.affiliation: Department of Surgery, Academic Medical Center, Amsterdam, Netherlands.
authors.forename: Djemila
authors.initials: D
authors.lastname: Boerma
authors.forename: Erik A J
authors.initials: EA
authors.lastname: Rauws
authors.forename: Yolande C A
authors.initials: YC
authors.lastname: Keulemans
authors.forename: Ignace M C
authors.initials: IM
authors.lastname: Janssen
authors.forename: Clemens J M
authors.initials: CJ
authors.lastname: Bolwerk
authors.forename: Ron
authors.initials: R
authors.lastname: Timmer
authors.forename: Egge J
authors.initials: EJ
authors.lastname: Boerma
authors.forename: Huug
authors.initials: H
authors.lastname: Obertop
authors.forename: Kees
authors.initials: K
authors.lastname: Huibregtse
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: Gouma
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017081:Cholecystectomy, Laparoscopic; D002769:Cholelithiasis / Q000601:surgery*; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016717:Sphincterotomy, Endoscopic; D013997:Time Factors