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Follow-Up After Bile Duct Sphincterotomy



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Am Fam Physician. 2003 Jan 15;67(2):397-398.

Stones in the common bile duct can be successfully extracted by endoscopic sphincterotomy in about 97 percent of patients. The procedure-related morbidity is low, about 5.8 percent, and mortality is estimated at 0.2 percent. The subsequent treatment of patients who have residual stones in the gall bladder remains controversial. Studies report that only about 10 percent of these patients develop biliary symptoms, leading to the wait-and-see policy of performing cholecystectomy only if the calculi become symptomatic. Conversely, the low rate of subsequent biliary symptoms could be attributed to limited follow-up. In this scenario, early cholecystectomy would avoid significant complications such as biliary colic, cholangitis, cholecystitis, and pancreatitis from the residual stones. Boerma and colleagues compared the outcomes of the traditional wait-and-see policy with elective laparoscopic cholecystectomy following successful endoscopic sphincterotomy to extract stones from the common bile duct.

They recruited adult patients who underwent successful endoscopic sphincterotomy for extraction of common bile duct stones in nine Dutch hospitals. Those who were not fit for further surgery and those who had no evidence of additional stones in the gall bladder were excluded from the study. The patients were randomly assigned to laparoscopic cholecystectomy within six weeks of sphincterotomy or wait-and-see conservative management with cholecystectomy performed only if indicated. The patients were followed for two years to record any biliary-related event. Quality of life was monitored during the median follow-up period of 30 months.

Patient characteristics, clinical features, and laboratory data were similar in the 56 patients randomized to laparoscopic cholecystectomy and the 64 allocated to the wait-and-see strategy. Data were available on 108 patients after six withdrew and six were lost to follow-up. Almost one half of the patients in the wait-and-see group had a biliary-related symptom during the study (see accompanying table). The most common symptom, uncomplicated biliary pain, was reported by 31 percent of patients, followed by cholecystitis (12 percent). Recurrent symptoms were particularly common in younger patients. Twenty-two (37 percent) patients requested cholecystectomy, and six underwent endoscopic retrograde cholangiopancreatography procedures. In the group assigned to laparoscopic cholecystectomy, nine surgeries were converted to open procedures, and six (14 percent) developed perioperative complications such as infection or hematoma. Quality-of-life measures showed no differences between the groups after three months.

Biliary Events During Follow-Up

Cholecystectomy (%)* Wait and see (%) Relative risk (95% CI) P value
Patients with at least one biliary event 1 (2%) 27 (47%)‡ 22.42 (3.16−159.14) <0.0001

Event

Uncomplicated pain

0

18 (31%)

Cholecystitis

0

7 (12%)

Cholangitis

0

0

Pancreatitis

0

0

Obstructive jaundice

0

1 (2%)

Gallstone ileus

0

0

Carcinoma

1 (2%)

0

Biliocutaneous fistula

0

1 (2%)

Cholecystectomy on demand

0

22 (37%)

Additional ERCP

0

6 (10%)

Death

0

0


CI = confidence interval; ERCP = endoscopic retrograde cholangiopancreatography. *—n = 49.

†—n = 59.

‡—p < 0.001.

Adapted with permission from Boerma D, Rauws EA, Keulemans YC, Janssen IM, Bolwerk CJ, Timmer R, et al. Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial. Lancet 2002;360:763.

Biliary Events During Follow-Up

View Table

Biliary Events During Follow-Up

Cholecystectomy (%)* Wait and see (%) Relative risk (95% CI) P value
Patients with at least one biliary event 1 (2%) 27 (47%)‡ 22.42 (3.16−159.14) <0.0001

Event

Uncomplicated pain

0

18 (31%)

Cholecystitis

0

7 (12%)

Cholangitis

0

0

Pancreatitis

0

0

Obstructive jaundice

0

1 (2%)

Gallstone ileus

0

0

Carcinoma

1 (2%)

0

Biliocutaneous fistula

0

1 (2%)

Cholecystectomy on demand

0

22 (37%)

Additional ERCP

0

6 (10%)

Death

0

0


CI = confidence interval; ERCP = endoscopic retrograde cholangiopancreatography. *—n = 49.

†—n = 59.

‡—p < 0.001.

Adapted with permission from Boerma D, Rauws EA, Keulemans YC, Janssen IM, Bolwerk CJ, Timmer R, et al. Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial. Lancet 2002;360:763.

The authors conclude that almost one half (47 percent) of patients assigned to the wait-and-see strategy had at least one biliary event, compared with 2 percent (one patient) in the group assigned to early laparoscopic cholecystectomy. They argue that the wait-and-see policy after endoscopic sphincterotomy in patients with residual gallbladder stones no longer can be recommended.

Boerma D, et al. Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial. Lancet. September 7, 2002;360:761–5.



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