LONG-TERM FOLLOW-UP OF A PROSPECTIVE RANDOMIZED STUDY OF ENDOSCOPIC VERSUS SURGICAL-TREATMENT OF BILE-DUCT CALCULI IN PATIENTS WITH GALLBLADDER IN-SITU

Eighty-three patients with bile duct calculi were entered in a prospec tive randomized study of endoscopic sphincterotomy (ES) and stone remo val (group 1) versus surgery alone (group 2), and were followed for mo re than 5 years. In group I endoscopic stone clearance was successful in 35 of 39 patients. Thirteen patients subsequently had cholecystecto my with (n = 7) or without (n = 6) biliary symptoms and one had a chol ecystostomy for acute cholecystitis. Two patients have had mild biliar y colic or pancreatitis. Two patients died from gallbladder carcinoma after 9 days and 18 months. In group 2 bile duct stones were cleared s urgically in 37 of 41 patients. Late complications occurred in two pat ients (incisional hernia and recurrent stone). One patient with gallbl adder carcinoma was cured and another died after 16 months. Early majo r and minor complications occurred in three and four respectively of 3 9 patients in group 1, and in three and six respectively of 41 patient s in group 2. There were no deaths. During follow-up the total morbidi ty rate reached 28 per cent (11 of 39) and 5 per cent (two of 41) (P = 0.005) and the non-biliary related mortality rate was 31 per cent (12 of 39) and 10 per cent (four of 41) (P = 0.02) in groups 1 and 2 resp ectively. Mine patients in group I and two in group 2 died from heart disease (P = 0.02). Total hospital stay was 2-42 (median 13) days and 6-36 (median 16) days in groups 1 and 2 respectively (P not significan t). Endoscopic and surgical treatment of bile duct calculi in middle-a ged and elderly patients with gallbladder in situ are equally effectiv e in the long term. However, the significantly increased mortality rat e from heart disease in patients treated endoscopically compared with those treated surgically might speak in favour of operation.