Prophylactic abdominal drainage or no drainage after distal pancreatectomy (PANDORINA): a binational multicenter randomized controlled trial

Prophylactic abdominal drainage is current standard practice after distal pancreatectomy (DP), with the aim to divert pancreatic fluid in case of a postoperative pancreatic fistula (POPF) aimed to prevent further complications as bleeding. Whereas POPF after pancreatoduodenectomy, by definition, involves infection due to anastomotic dehiscence, a POPF after DP is essentially sterile since the bowel is not opened and no anastomoses are created. Routine drainage after DP could potentially be omitted and this could even be beneficial because of the hypothetical prevention of drain-induced infections (Fisher, 2018). Abdominal drainage, moreover, should only be performed if it provides additional safety or comfort to the patient. In clinical practice, drains cause clear discomfort. One multicenter randomized controlled trial confirmed the safety of omitting abdominal drainage but did not stratify patients according to their risk of POPF and did not describe a standardized strategy for pancreatic transection. Therefore, a large pragmatic multicenter randomized controlled trial is required, with prespecified POPF risk groups and a homogeneous method of stump closure.

 

The objective of the PANDORINA trial is to evaluate the non-inferiority of omitting routine intra-abdominal drainage after DP on postoperative morbidity (Clavien-Dindo score ≥ 3), and, secondarily, POPF grade B/C.

Patients undergoing elective DP will be randomly allocated in a 1:1 ratio to no prophylactic abdominal drainage or prophylactic abdominal drainage after surgery, stratified based on the risk of POPF. This protocol was developed according to the SPIRIT guidelines [20]. Total inclusion time of the study is planned to be 24 months from start of recruitment and the total study time 36 months. The study structure includes setup of sites (4–6 months), enrollment (24–30 months), and data analysis and reporting results (4 months).



In case of readmission related to surgery within 90 days after initial discharge, follow-up for secondary outcomes will be extended to the entire duration of readmission.

Omitting abdominal drainage after distal pancreatectomy

PANDORINA is the first binational, multicenter, randomized controlled non-inferiority trial with the primary objective to evaluate the hypothesis that omitting prophylactic abdominal drainage after DP does not worsen the risk of postoperative severe complications [18, 19]. The focus of this study is to assess if operative placed drains lead to less complicated POPF which need a reintervention or reoperation. However, POPF B/C without intervention cannot be measured in the no drain arm of our study since this is because of prolonged operative drainage. Therefore, the primary endpoint is chosen to be severe morbidity, while this is caused by a POPF grade B/C, on which the clinical focus will lie. Most of the published studies on drain placement after pancreatectomy focus on both pancreatoduodenectomy and DP, but these two entities present are associated with different complications and therefore deserve separate evaluation [29, 30]. The PANDORINA trial is innovative since it takes the preoperative risk on POPF into account based on the D-FRS and it warrants homogenous stump closing by using the same graded compression technique and same stapling devive [22, 24].