Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Pancreaticoduodenectomy; Drainage
• Interventions: Other: Late drain removal; Other: Early drain removal

• Registration Number: NCT03055676
• Lead Sponsor: Peking Union Medical College Hospital

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).

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-16
• Primary Completion: 2020-03
• Status Verified: 2020-04
• Study Completion: 2020-04
• Last Update Submitted: 2020-04-21
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

Inclusion Criteria

1. PD with or without pylorus preserving;
2. Age between 18 and 75 years;
3. Drain amylase on POD 1 and 3 less than 5000 U/L;
4. Drain output within POD 3 less than 300 ml per day.

Exclusion Criteria

1. Vascular reconstruction using an artificial graft;
2. Grade B/ C postoperative bleeding, evident anastomosis leakage within 3 days after surgery;
3. Refusale to participate in after signed informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late drain removal	Late drain removal	Removing drain(s) on postoperative day 5 or later (n = 166)
Early drain removal	Early drain removal	Removing drain(s) on postoperative day 3 (n = 166)

Primary Outcome Measures

Name	Time	Method
The sum of grade 2- 4 complications	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 Outcome Measures

Name	Time	Method
Intra-abdominal bleeding	Up to postoperative 90 days	The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
Comprehensive complication index (CCI)	Up to postoperative 90 days	integrates all complications of the Clavien-Dindo classification (CDC) and offers a metric approach to measure morbidity.
Total medical expenses	Up to postoperative 90 days	Total medical expenses during hospitalization.
Length of hospital stay (day)	Up to postoperative 90 days	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Delayed gastric emptying	Up to postoperative 90 days	The International Study Group of Pancreatic Surgery (ISGPS) definition: Inability to return to a standard diet by the end of the first postoperative week with prolonged nasogastric intubation.
Grade B/C complications	Up to postoperative 90 days	The International Study Group of Pancreatic Surgery (ISGPS) definition
Any other single intem of grade 2-4 complication	Up to postoperative 90 days	Clavein Dindo Classification is adopted.
Interventional treatment	Up to postoperative 90 days	interventional treatment for any complication.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China