For possible common duct stones, do intraop cholangiogram before ERCP: study

By James E. Barone MD

NEW YORK (Reuters Health) - Patients at intermediate risk for common bile duct stones who had cholangiography during cholecystectomy - with endoscopic retrograde cholangiopancreatography (ERCP) afterward only if needed - did just as well as those who had ERCP before cholecystectomy, researchers say.

"This strategy decreases the length of stay, the need for endoscopic and radiologic investigations and, indirectly, the costs," said surgeons Dr. Pouya Iranmanesh and Dr. Christian Toso, both of Geneva University Hospital in Switzerland, in a joint email to Reuters Health.

It is also associated with a safe risk profile and a well-maintained quality of life, they reported online July 8 in JAMA.

Their intermediate-risk criteria were age above 55, biliary pancreatitis, or moderately elevated liver function tests. High-risk markers are bilirubin above 4, ascending cholangitis, common duct stones on ultrasound, or a common duct diameter >6 mm with a mildly elevated bilirubin, the authors say.

In their trial, patients with acute cholecystitis and intermediate risk were randomized to either cholecystectomy and intraoperative cholangiography (IOC) within 48 hours of admission, with intraoperative or postoperative ERCP only if necessary, or to endoscopic ultrasound (EUS) or magnetic resonance cholangiopancreatography (MRCP) with ERCP if needed, followed by cholecystectomy and IOC (i.e., the control group).

Excluded were patients with sepsis, lipase values three times normal, CT evidence of pancreatitis, previous surgery precluding ERCP, contraindications to MRCP, or inability to consent to participation in the study.

After assessing 151 patients for eligibility, 51 were excluded, and 50 were randomized to each group. Three patients in the cholecystectomy-first group did not receive the intervention. Two had contraindications to anesthesia and one had acute pancreatitis. Two patients in the control group did not have surgery due to the findings of alternate diagnoses for their abnormal liver function studies.

The two cohorts were similar in age, sex distribution, body mass index, American Society of Anesthesiologists' score, and laboratory values.

The median hospital stay was five days in the surgery-first group vs. eight days in controls (p<0.001).

Dr. Nicholas Alexakis, a surgeon at the University of Athens Medical School in Greece who has done research on this topic, told Reuters Health this was a well-conducted randomized clinical trial from a reputable center. In his opinion, however, "the primary end points should be successful CBD clearance, morbidity and mortality and number of additional procedures needed, and not hospital stay."

Patients in the control group had 71 total EUS, MRCP, and ERCP studies vs. 25 in those who had surgery first (p<0.001).

No patient in either group underwent surgical common duct exploration.

Operative times, conversions from laparoscopy to laparotomy, reoperations, and readmissions were similar in the two groups.

Common duct stones were found in 11 patients who had surgery first - 10 on IOC and one on postoperative ERCP. The 10 identified on IOC had postop EUS exams. According to Drs. Iranmanesh and Toso, approximately 21% of CBD stones spontaneously migrate to the duodenum. They said, "EUS was performed postoperatively in patients with an IOC showing CBD stones to confirm the diagnosis and avoid unnecessary ERCPs."

Ten control patients had common duct stones, discovered in eight on preoperative EUS and in two on IOC. The eight patients with stones found on EUS had successful preoperative ERCPs. One of the other two patients had intraoperative irrigation of the common duct which flushed the stone and the other had a postoperative ERCP.

The incidence and severity of complications were similar in both groups, as were postoperative quality of life scores.

The authors did not do a formal cost analysis but pointed out that shorter hospital stays and fewer common duct investigations suggests considerably lower costs with a strategy of surgery plus IOC first.

At the authors' institution, IOCs are performed on all patients undergoing cholecystectomy regardless of the risk of CBD stone. They feel that IOC helps identify CBD stones, interval migration, and minimizing and identifying iatrogenic bile duct lesions.

Dr. Alexakis, however, does not advocate routine IOC. "IOC increases operating time and cost," he said. "The interpretation is subjective and can have false positive and false negative results."

At his hospital, patients with an intermediate risk of CBD stones have MRCP before surgery and ERCP if stones are found.

"When we launched the trial, the standard management of patients with an intermediate risk of CBD stones was to perform systematic preoperative CBD assessment," said the corresponding authors. "We felt that this strategy was not optimal and therefore decided to design this trial. Our team now treats these patients using a 'cholecystectomy first' strategy."

SOURCE: http://bit.ly/1stPmP0

JAMA 2014.