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NEW YORK (Reuters Health) - After endoscopic sphincterotomy in combined cholecystolithiasis, a wait-and-see policy cannot be recommended over routine cholecystectomy because many patients develop recurrent biliary events, Dutch researchers report.
Dr. Dirk J. Gouma from the Academic Medical Center, Amsterdam, and colleagues randomly assigned 120 patients to a wait-and-see approach or to laparoscopic cholecystectomy after endoscopic sphincterotomy and stone extraction. The primary outcome was the recurrence of at least one bilary event during 2 years of follow-up.
Intention-to-treat analysis found that of the 59 patients in the wait-and-see group, 27 (47%) had a recurrent bilary event, compared with 1 of the 49 patients (2%) who underwent laparoscopic cholecystectomy (relative risk 22.42, p < 0.0001), the researchers report in the September 7th issue of The Lancet.
Of the 27 patients in the wait-and-see group with recurrences, 22 underwent cholecystectomy. The conversation rate to open surgery in this group was 55%, compared with only 23% among patients assigned to immediate laparoscopic cholecystectomy, Dr. Gouma's team reports.
Also, among patients operated on in the wait-and-see group, postoperative morbidity was 32% compared with 14% for patients in the laparoscopic cholecystectomy group. Furthermore, length of hospital stay was 9 days compared with 7 days, respectively.
Dr. Gouma and colleagues conclude that "a wait-and-see policy after sphincterotomy for common bile-duct stones, as suggested in nonrandomized studies and as postulated in the set-up of our trial, cannot be recommended routinely."
In a journal editorial, Dr. Alfred Cuschieri from the University of Dundee, UK, expresses the hope that the findings will not be used to perpetuate the two-stage treatment of such patients when there have been great advances in laparoscopic, single-stage management.
"There will continue to be patients in whom endoscopic stone extraction is required in the first instance," he writes. "Thus the endoscopists should not be concerned that they will lose out to the biliary laparoscopic surgeons. Battles over turf should not arise, but training issues will," he adds.
Lancet 2002;360:739-740,761-765.
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