SAN FRANCISCO – Patients with primary sclerosing cholangitis may not benefit from cholecystectomy for small gallbladder polyps, based on a Mayo Clinic study.
Polyps smaller than 0.8 cm on ultrasound were benign in all cases studied, and surgical complications were common when 57 primary sclerosing cholangitis (PSC) patients had cholecystectomies at the Mayo Clinic in Rochester, Minn.
A baseline Child-Pugh score of 7 or greater was linked to increased risk of early postoperative complications.
"We have to be careful who we send for cholecystectomy for these very small lesions, given the morbidity associated with the procedure," said lead investigator Dr. John Eaton, chief medical resident in internal medicine at the Mayo Clinic.
"If you are looking at a [small] lesion and see something that’s concerning" – for instance, adjacent-wall thickening or arterial blood flow – "then it’s a case-by-case decision, [but it] needs to be made with this information in the background," he said at the annual meeting of the American Association for the Study of Liver Diseases.
Cholecystectomies are currently recommended to remove gallbladder lesions – whatever the size – in PSC patients because they are at greater risk for gallbladder cancer. It hasn’t been clear, though, whether the surgery is necessary for small polyps, or whether patients encounter complications after cholecystectomy, Dr. Eaton said.
Almost 70% percent (39) of the subjects were men. The PSC was histologic stage I or II in about half (54%) of the total cohort (31 of 57 patients). Gallbladder lesions on ultrasound were the most common indications for surgery. People with prior liver transplants or history of cholangiocarcinoma were excluded from the study.
For the cholecystectomies, about half of the patients had a laparoscopic procedure. Seventeen patients (30%) had additional surgeries when their gallbladders were removed.
Only seven polyps were smaller than 0.8 cm on preoperative ultrasounds; all of these proved to be benign, most often granulomas or normal tissue. The smallest polyp with low-grade dysplasia was 0.8 cm, and the smallest adenocarcinoma was 1.2 cm. As expected, larger growths were more likely to be cancerous.
The 0.8-cm cut-off was 100% sensitive and 70% specific for gallbladder neoplasia; the area under the receiver operating characteristic curve (AUC) was 0.90. "It’s pretty strong" as a predictor, Dr. Eaton said.
A 1.20-cm cut-off was 100% sensitive and 79% specific for gallbladder cancer, with an AUC of 0.93.
Twenty-three patients (40%) had a complication within 6 weeks after surgery, some with more than one. Bile leaks were most common. One patient required a liver transplant. A baseline Child-Pugh score of 7 was 41% sensitive and 88% specific for early postoperative complications.
Regarding longer-term follow-up, 53 patients were followed for a total of 259 patient-years. The only baseline characteristic associated with death or transplant was a PSC stage of IV (hazard ratio, 8.10; 95% confidence interval, 1.27-161.18; P = .02).
The researchers concluded that "gallbladder polyps less than 0.8 cm [on ultrasound] can be observed in patients with PSC given the low probability of malignancy and [the] high morbidity associated with a cholecystectomy."
However, the study "in no way comments on the natural history or progression [of gallbladder polyps]. If we detect one of these small lesions, well then what happens? We really can’t comment on what we should do after that," for example, whether it should be frequent ultrasounds and watchful waiting or some other approach, Dr. Eaton said.
Dr. Eaton said he has no disclosures.