Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

Study Overview
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Brief Summary
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Despite a substantial decrease in postoperative mortality, morbidity after pancreatic resections is still high, even at high-volume centers. It has been recently suggested that early removal of postoperative drainages is associated to a decreased rate of intra-abdominal complications, with particular regard to pancreatic fistula. Furthermore, our research group demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a cardinal role in predicting the developement of abdominal complications, including pancreatic fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were considered at low risk of fistula. Therefore, the investigators designed a randomized prospective trial on early (postoperative day 3) versus standard (postoperative day 5) drainages removal after pancreatic resections in patients at low risk of developing pancreatic fistula (AVD < 5000 IU/L in postoperative day 1) to test whether drainages per se influence postoperative complication rates and to eventually validate a fast-track policy in pancreatic resections.

Official Title
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Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial

Conditions
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Pancreaticoduodenectomy, Distal Pancreatectomy, Pancreatic Fistula, Abdominal Abscess

Intervention / Treatment
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* Procedure: Postoperative drain removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergone either pancreaticoduodenectomy (reconstruction by pancreaticojejunostomy) or distal pancreatectomy with an amylase value in drains on postoperative day 1 less than 5000 IU/L Exclusion Criteria: Pancreaticoduodenectomy reconstructed with pancreaticogastrostomy Clinical suspect of postoperative haemorrhage within 72hours after the operation Clinical suspect of biliary fistula Fluid collection greater than 3cm at an ultrasound carried out on postoperative day 3
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early drain removal<br>Drain removal in postoperative day 3 | Procedure: Postoperative drain removal<br>* removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)<br>|
| Active Comparator: Standard drain removal<br>Drain removal on postoperative day 5 | Procedure: Postoperative drain removal<br>* removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal Complications |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital stay |  | 1 month | 
| Pulmonary complications |  | 1 month | 
| Hospital readmission |  | 1 month |