Laparoscopic cholecystectomy bests catheter drainage in high-risk cholecystitis

Last Updated: 2018-10-26

By Scott Baltic

NEW YORK (Reuters Health) - Laparoscopic cholecystectomy is superior to percutaneous catheter drainage in treating acute calculous cholecystitis in high-risk patients - that is, those with APACHE II scores of 7 or more - according to a new clinical trial from the Netherlands.

In addition, cholecystectomy reduced the rate of major complications, including infectious and cardiopulmonary complications, the need for re-intervention, and recurrent biliary disease. It also lowered treatment costs by more than 30%.

In high-risk patients, "the management of acute cholecystitis remains controversial," note Dr. Djamila Boerma of St. Antonius Hospital, in Nieuwegein, and colleagues in The BMJ, online October 8.

"Therefore," they add, "imaging guided percutaneous catheter drainage is increasingly being performed as an alternative to early cholecystectomy."

The new study is the first randomized trial to compare laparoscopic cholecystectomy and percutaneous catheter drainage in this type of patient population, Dr. Boerma told Reuters Health by email.

The researchers recruited patients at 11 teaching hospitals in the Netherlands, excluding those with an APACHE II score of 15 or more. The cholecystectomy procedure was performed with the four-trochar technique by surgeons who each performed more than 100 laparoscopic procedures a year.

Percutaneous catheter drainage was performed by or under the supervision of qualified radiologists, with gallbladder puncture done by the transhepatic or the transperitoneal route.

The primary endpoints were death within one year and occurrence of major complications, that is, infectious and cardiopulmonary complications within one month, the need for re-intervention within one year, or recurrent biliary disease within one year.

In December 2015, with nearly half of the planned 284 patients having been enrolled, an interim analysis for the primary endpoints was done. At that time, 118 of 138 patients had completed follow-up.

Based on the P-value of the difference between the two groups being below the prespecified threshold of 0.001, in February 2016 the data safety monitoring board recommended terminating the trial.

Major complications occurred in 12% of the 66 patients assigned to cholecystectomy and 65% of the 68 patients assigned to drainage (risk ratio, 0.19; P < 0.001).

Re-interventions related to cholecystitis were performed less often after cholecystectomy than after percutaneous drainage, and recurrent biliary disease also occurred less often in patients assigned to cholecystectomy (P<0.001 for both).

Emergency cholecystectomy was performed in 16% of patients assigned to percutaneous catheter drainage, and elective cholecystectomy was performed in 29%.

The rates of death did not differ significantly between the two groups.

Including readmissions, the average total length of hospital stay was five days in the cholecystectomy group and nine days in the drainage group (P<0.001).

The mean direct medical costs per patient during a follow-up of one year from entry into the study were 4,993 (US$6,381) for cholecystectomy and 7,427 ($9,492) for drainage.

"It is clear that in patients with a strict contraindication for surgery, percutaneous drainage is an appropriate treatment," Dr. Boerma said. However, she added, "the gallbladder remains in situ and does cause recurrent symptoms and readmissions in the majority of patients."

In this study, she continued, "we demonstrated that high-risk patients with acute cholecystitis should undergo early/immediate cholecystectomy," as the procedure is safe and effective when performed by experienced laparoscopic surgeons.

"Delayed cholecystectomy after acute cholecystitis (after 6 weeks) is known to be related to higher complication rates than immediate cholecystectomy. Since the gallbladder should probably be taken out anyway, do it immediately," Dr. Boerma recommended.

Dr. Taylor S. Riall, chief of the division of general surgery/surgical oncology at the University of Arizona College of Medicine, in Tucson, told Reuters Health by email, "This study raises an important question, as there is controversy regarding both when to place a cholecystostomy tube (or simply manage with antibiotics and not surgery) and when to proceed to laparoscopic cholecystectomy."

As the first randomized controlled trial to provide data on patients with APACHE II scores over 7 on admission with acute cholecystitis, this study "can help refine the current Tokyo Guidelines for management of severe, grade III cholecystitis," she said.

"In the U.S.," continued Dr. Riall, who was not part of the study, "there is a move toward definitive treatment (cholecystectomy) for severe disease in experienced centers, and these data support that direction."

The study "does not, however, provide definitive information for patients with higher APACHE II scores, nor does it provide information about management after cholecystostomy tube placement. It does stress the fact that cholecystectomy should be planned after cholecystostomy tube placement, which, in my mind is a critical take-away from this study," she concluded.

SOURCE: https://bit.ly/2SkOm39

BMJ 2018.