Endoscopic ultrasound–guided transmural gallbladder drainage was as safe and effective as was percutaneous transhepatic gallbladder drainage in patients with acute cholecystitis who did not respond to medical therapy and were unsuitable for emergency cholecystectomy, according to a report by Dr. Ji-Woong Jang and colleagues in the April issue of Gastroenterology.
In a noninferiority trial that directly compared the two approaches among 59 consecutive patients, the rates of technical success and clinical success were comparable. There also were no differences in complication rates or in conversion to open cholecystectomy.
Therefore, endoscopic ultrasound–guided transmural gallbladder drainage (EUS-GBD) may be a safe alternative treatment for high-risk patients with acute cholecystitis who are not candidates for emergency cholecystectomy, they said.
Dr. Jang and associates performed what they described as the first prospective, randomized controlled trial to compare the two procedures. Until now, the literature has included only case reports or pilot studies of EUS-GBD, while percutaneous transhepatic gallbladder drainage (PTGBD) has been used for decades in high-risk patients and is considered the preferred method of treatment.
Despite its usefulness, PTGBD has been associated with adverse events such as bleeding, pneumothorax, and bile peritonitis. It is contraindicated in patients with massive ascites or coagulopathy. And the drainage catheters cause pain, restrict patients’ movements, and are subject to inadvertent removal or migration.
In contrast, EUS-GBD can be used when there are large amounts of perihepatic ascites and when patients have coagulopathy or have been taking antiplatelet or antithrombotic medications. The procedure minimizes bleeding because the puncture site is less vascularized than the primary puncture site for PTGBD, the liver. There is less pain with EUS-GBD because the puncture site is less sensitive to pain, and the nasobiliary tube is less likely to be dislodged, said Dr. Jang of the department of gastroenterology, Asan Medical Center, Seoul, South Korea, and colleagues.
In this study, 30 of the 59 adults were randomly assigned to undergo EUS-GBD, and 29 to undergo PTGBD. The two groups were similar in terms of age, gender, underlying conditions, and causes of cholecystitis. The patients presented to a single medical center during a 6-month period.
For EUS-GBD, patients were sedated and the initial puncture was made at the prepyloric antrum of the stomach or the bulb of the duodenum, so that the gallbladder body or neck could be accessed while blood vessels were visualized and avoided. A 19-gauge needle was inserted into the stomach or duodenal wall and into the gallbladder, and a guidewire was passed and coiled in the gallbladder.
A bougie was then used to dilate this tract. A 5F nasobiliary drainage tube was then coiled into the gallbladder. Using a tube this size obviates the need for a larger tract, which is the main cause of bile leakage in PTGBD, they noted.
For PTGBD, local anesthesia was used and an 8.5 F pigtail drainage catheter was passed transhepatically and placed between the seventh or eighth intercostal space under sonographic and fluoroscopic guidance.
All the study subjects were followed for a minimum of 3 months. The primary end point was the technical success rate, defined as the ability to access and drain the gallbladder by placement of a drainage tube, or maintenance of good drainage tube function.
This end point was achieved in 29 of 30 EUS-GBD patients (97%) and 28 of 29 PTGBD patients (97%), qualifying the new procedure as noninferior to the standard method.
A secondary end point was the clinical success rate, defined as improvement of typical symptoms and laboratory tests, with or without improved radiologic findings, 3 days after the procedure. This was achieved in all 29 of the EUS-GBD patients and 27 of 28 (96%) of the PTGBD patients.
The average procedure time was 23 minutes for EUS-GBD and 24 minutes for PTGBD. Postoperative pain level was significantly lower with EUS-GBD.
Two patients (7%) in the EUS-GBD group and 1 (3%) in the PTGBD group developed complications. The EUS-GBD patients both developed pneumoperitoneum, which was managed conservatively, and the PTGBD patient developed hemobilia, which responded to transfusion of packed red blood cells.
No EUS-GBD patients had nasobiliary tube dislodgement, while 1 PTGBD patient had catheter dislodgement. EUS-GBD also did not cause severe inflammation or adhesions in the tissue surrounding the gallbladder, nor did it cause bile leakage or bile peritonitis, which is the chief risk associated with the procedure, Dr. Jang and associates said.
The study was supported by a grant from the Asan Institute for Life Sciences. The authors declared no conflicts of interest.