Postoperative drainage after pancreatoduodenectomy: a randomized controlled trial among patients with intermediate and low risks for pancreatic fistula-DRAIN1.

BACKGROUND: Routine use of surgical drains after abdominal operations has largely been abandoned over the past decades. Studies have failed to demonstrate benefits of routine drainage following liver, gallbladder, gastric, and colorectal surgeries. Until recently, intraoperative placement of abdominal drains was the gold standard in pancreatoduodenectomies (PDs) due to concerns about uncontrolled postoperative pancreatic fistula (POPF). A large randomized trial in 2014 reported increased mortality in patients without postoperative drain placement. However, as the study did not stratify participants based on their preoperative risk of developing a POPF, further research is needed. Limited evidence from a non-randomized cohort suggests that omitting drains may be safe in very low-risk settings. However, a larger comparative study, including a broader range of PD cases, is necessary to confirm these findings.

METHODS: This is a two-arm, randomized, controlled, non-blinded, multicenter trial comparing intra-abdominal drain placement with no drain placement during planned pancreatoduodenectomies (PDs). Eligible patients who meet the inclusion criteria will be assessed for their individual risk of postoperative pancreatic fistula (POPF) using a risk scoring system. They will then be randomized into either the drain placement or no drain placement group. The groups will be compared using the chi-square test for categorical variables and Fisher's exact test. Logistic regression models will be used to calculate odds ratios for morbidity. Univariable and multivariable models will assess the impact of drain placement on clinical outcomes.

DISCUSSION: This trial aims to determine whether omitting routine intraoperative drain placement reduces the risk of complications in patients undergoing pancreatoduodenectomy (PD). It will provide level 1 evidence on the association between routine intra-abdominal drainage and postoperative complications in patients with a low to intermediate risk of developing a postoperative pancreatic fistula (POPF). The findings will contribute to future treatment guidelines by expanding the available knowledge on optimal drainage strategies.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05270564. Registered on February 16 2022.