Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial

Official title: A Randomized Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

Status Completed

Clinical Trial Summary

The aim of this randomized prospective multicenter study is to demonstrate the hypothesis that early removal of drain could reduce the incidence of major complications (grade 2-4) after pancreaticoduodenectomy (PD) , when compared with later removal of drain.

Clinical Trial Description

The objective of this randomized prospective multicenter study is to investigate the association between the time of removal of drain after pancreaticoduodenectomy (PD) and incidence of major complications (grade 2-4 complications). The investigators unite six pancreatic surgery center in Beijing. Patients who underwent pancreaticoduodenectomy (PD) or pylorus-preserving pancreaticoduodenectomy (PPPD) with low to moderate risk of post-operative pancreatic fistula (POPF) are recruited into the study. After obtaining informed consent, eligible patients are randomly allocated to early or late drain removal group on POD 3. In the group A, drain(s) are removed on POD 3, whereas in group B drain is removed on POD 5 or beyond. The primary outcomes are the incidence of sum of grade 2-4 complications, the secondary outcomes include grade B/C POPF, intra-abdominal infeciton, delayed gastric emptying, post-operative bleeding, in-hospital stay, total medical cost and comprehensive complication index (CCI). ;

Related Conditions & MeSH terms

• Drainage
• Pancreaticoduodenectomy

• NCT number: NCT03055676
• Study type: Interventional
• Source: Peking Union Medical College Hospital
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Completion date: April 2020