Grade B or C postoperative pancreatic fistula occurred in significantly fewer patients in the no-drain versus drain groups
By Elana Gotkine HealthDay Reporter
MONDAY, April 1, 2024 (HealthDay News) — For patients with distal pancreatectomy, a no-drain policy is noninferior in terms of major morbidity, according to a study published online March 15 in The Lancet Gastroenterology and Hepatology.
Eduard A. van Bodegraven, M.D., from the University of Amsterdam, and colleagues examined the noninferiority of a no-drain policy in patients with distal pancreatectomy in a multicenter, randomized, noninferiority trial. Patients undergoing open or minimally invasive elective distal pancreatectomy for all indications were randomly assigned intraoperatively to no drain or prophylactic passive drain placement (138 and 144, respectively). Seven patients in the no-drain group received a drain intraoperatively, resulting in a per-protocol population of 131 and 144, respectively.
The researchers found that in the intention-to-treat analysis, the rate of major morbidity was noninferior in the no-drain versus the drain group (15 versus 20 percent); similar results were seen in the per-protocol analysis (16 versus 20 percent). In the intention-to-treat analysis, grade B or C postoperative pancreatic fistula occurred in 12 and 27 percent of patients in the no-drain and drain groups, respectively. Three patients in the no-drain group died within 90 days; two deaths were unrelated to the trial. Within 90 days, no patients from the drain group died.
“We expect these results to be practice-changing and encourage the implementation of a no-drain policy as the new standard approach in eligible patients undergoing distal pancreatectomy,” the authors write.
Several authors disclosed ties to medical device companies, including Ethicon, which funded the study.
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