Early Versus Late Drain Removal After Pancreatectomy: A Randomized Prospective Trial

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to demonstrate the hypothesis that early removal of drain can reduce the incidence of intra-abdominal infection and pancreatic fistula after pancreatectomy compared with later removal of drain.

Detailed Description
-----------------
This study is to analyze the association between the time of removal of drain after pancreatic resection and incidence of intra-abdominal complications, such as intra-abdominal infection and pancreatic leakage. We design a prospective randomized study. Patients with pancreatic and periampullar tumors who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) are recruited to the study if amylase value in drain(s) is less than 5000 U/L on postoperative day (POD) 1. 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 4 or beyond. The primary outcomes are the incidence of intra-abdominal infection and pancreatic fistula; the secondary outcomes include intra-abdominal bleeding, delayed gastric emptying, pulmonary complications, and length of hospital stay.

Official Title
-----------------
The Impact of Early Versus Late Drain Removal on Postoperative Morbidity After Pancreatectomy: A Randomized Prospective Trial

Conditions
-----------------
Pancreatectomy, Post Procedural Discharge

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: >18yr, <75yr Patients with pancreatic diseases (including tumor and inflammatory disease) or non-pancreatic tumors (biliary duct cancer or ampullary tumor) who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) The amylase value in drain(s) is less than 5000 U/L on postoperative day 1 and 3. Exclusion Criteria: Reconstruction of the pancreatic remnant by pancreaticogastrostomy Intra-abdominal hemorrhage within 72 hours after operation Biliary fistula (output of biliary fluid from at least 1 abdominal drain) within 72 hours after operation Chylous leakage (milky water) within 72 hours after operation The volume of drain effluent (ascites) is greater than 300 ml within 72 hours after operation.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 = 72) | Other: Early drain removal<br>* Removing drain(s) on postoperative day 3<br>|
| Experimental: Late drain removal<br>Removing drain(s) on postoperative day 4 or later (n = 72) | Other: Late drain removal<br>* Removing drain(s) on postoperative day 4 or later<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-abdominal infection | Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test. | Up to postoperative 30 days | 
| Pancreatic fistula | The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course. | Up to postoperative 30 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 30 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 30 days | 
| Pulmonary complications | Including pulmonary infection and atelectasis. | Up to postoperative 30 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 2 weeks | 

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