A Randomized Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreaticoduodenectomy
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 319
- Locations
- 1
- Primary Endpoint
- The sum of grade 2- 4 complications
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •PD with or without pylorus preserving;
- •Age between 18 and 75 years;
- •Drain amylase on POD 1 and 3 less than 5000 U/L;
- •Drain output within POD 3 less than 300 ml per day.
Exclusion Criteria
- •Vascular reconstruction using an artificial graft;
- •Grade B/ C postoperative bleeding, evident anastomosis leakage within 3 days after surgery;
- •Refusale to participate in after signed informed consent.
Outcomes
Primary Outcomes
The sum of grade 2- 4 complications
Time Frame: Up to postoperative 90 days
The severity of complication was measured by Clavein Dindo classifications and grade 2- 4 complications always affect the recovery of the patients significantly.However, the death case (grade 5 complication) is rare now for PD in high volume centers. According to our single center study, early drain removal could reduce the rate of grade 2-4 complications by 12% for the patients undergoing major pancreatectomy.
Secondary Outcomes
- Intra-abdominal bleeding(Up to postoperative 90 days)
- Comprehensive complication index (CCI)(Up to postoperative 90 days)
- Total medical expenses(Up to postoperative 90 days)
- Length of hospital stay (day)(Up to postoperative 90 days)
- Delayed gastric emptying(Up to postoperative 90 days)
- Grade B/C complications(Up to postoperative 90 days)
- Any other single intem of grade 2-4 complication(Up to postoperative 90 days)
- Interventional treatment(Up to postoperative 90 days)