Status:
UNKNOWN
Early Versus Late Drain Removal After Pancreatectomy: A Randomized Prospective Trial
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Pancreatectomy
Post Procedural Discharge
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 pancreati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT02230436
Start Date
July 1 2014
End Date
December 1 2017
Last Update
February 23 2017
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730