NCT04609137: Early-Dist

Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy (Early-Dist)

Completed NA Last updated 18 January 2024

What this trial tests

NA trial testing Early drain removal in Pancreas Disease in 150 participants. Completed in 30 October 2023.

Timeline

13 October 2020

Primary endpoint
30 September 2023

30 October 2023

Quick facts

Lead sponsor	IRCCS San Raffaele
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	150
Start date	13 October 2020
Primary completion	30 September 2023
Estimated completion	30 October 2023
Sites	1 location across Italy

Drugs / interventions tested

• Early drain removal
• Standard drain removal

Conditions studied

• Pancreas Disease — all drugs for Pancreas Disease →
• Complication,Postoperative — all drugs for Complication,Postoperative →
• PROMs — all drugs for PROMs →
• Pancreatic Fistula — all drugs for Pancreatic Fistula →

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

18 and older, any sex, with Pancreas Disease or Complication,Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Main indications for distal pancreatectomy (DP) are pancreatic body and tail tumors including ductal adenocarcinoma, neuroendocrine tumors, and cystic neoplasms. Despite a less invasive operation with lower morbidity compared to pancreatic head surgery, DP is burdened by the occurrence of clinically-relevant postoperative pancreatic fistula (CR-POPF) in a significant proportion of patients.

Drain fluid amylase (DFA) on POD 1 (postoperative day 1) \> 2,000 U/L appears as the best performing threshold to predict the occurrence of CR-POPF after distal pancreatectomy. Although there is preliminary evidence that early drain removal in the subgroup of patients with DFA1 \< 2,000 U/L may reduce POPF, no prospective study has yet evaluated the impact of an early drain removal strategy compared to standard management.

The research question of this study is to evaluate to what extent early postoperative drain removal according to a validated DFA1 impact on clinically-relevant POPF rate after distal pancreatectomy in comparison to standard drain management. The primary hypothesis is that, early drain removal will result in a reduced proportion of patients experiencing grade B-C POPF according to ISGPS definition.

The proposed study is a two-group, assessor-blind, randomized trial. Participants will be randomly assigned with a 1:1 ratio into one of two groups: (1) standard drain management or (2) early drain removal strategy.

In this study adults (\>18 years) patients with pancreatic body or tail diseases planned for distal pancreatectomy with or without splenectomy will be enrolled.The primary outcome is the POPF at 90 days after surgery, defined as grade B or C POPF according to ISGPS definition.

Participants will be asked to complete some questionnaires in order to assess their general health status, and they will be evaluated at time of hospital admission, at 15 days, at 30 days after surgery (via telephone follow-up), and at 90 days after surgery (via telephone follow-up).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prophylactic abdominal drainage for pancreatic surgery.
   Miao C, Hu Y, Bai G, Cheng N, et al · · 2025 · cited 2× · PMID 40377137 · DOI 10.1002/14651858.cd010583.pub6