Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Drainage, Pancreaticoduodenectomy

Intervention / Treatment
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* Other: Early drain removal
* Other: Late drain removal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early drain removal<br>Removing drain(s) on postoperative day 3 (n = 166) | Other: Early drain removal<br>* Removing drain(s) on postoperative day 3<br>|
| Active Comparator: Late drain removal<br>Removing drain(s) on postoperative day 5 or later (n = 166) | Other: Late drain removal<br>* Removing drain(s) on postoperative day 5 or later<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sum of grade 2- 4 complications | 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. | Up to postoperative 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-abdominal bleeding | 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. | Up to postoperative 90 days | 
| Delayed gastric emptying | 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. | Up to postoperative 90 days | 
| Grade B/C complications | The International Study Group of Pancreatic Surgery (ISGPS) definition | Up to postoperative 90 days | 
| Length of hospital stay (day) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. | Up to postoperative 90 days | 
| Comprehensive complication index (CCI) | integrates all complications of the Clavien-Dindo classification (CDC) and offers a metric approach to measure morbidity. | Up to postoperative 90 days | 
| Interventional treatment | interventional treatment for any complication. | Up to postoperative 90 days | 
| Total medical expenses | Total medical expenses during hospitalization. | Up to postoperative 90 days | 
| Any other single intem of grade 2-4 complication | Clavein Dindo Classification is adopted. | Up to postoperative 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreaticoduodenectomy, Time of drain removal