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

Not Applicable

• Conditions: Pancreatectomy; Post Procedural Discharge
• Interventions: Other: Late drain removal; Other: Early drain removal

• Registration Number: NCT02230436
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-16
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-03
• Status Verified: 2016-08
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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.

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 4 or later (n = 72)
Early drain removal	Early drain removal	Removing drain(s) on postoperative day 3 (n = 72)

Primary Outcome Measures

Name	Time	Method
Intra-abdominal infection	Up to postoperative 30 days	Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
Pancreatic fistula	Up to postoperative 30 days	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.

Secondary Outcome Measures

Name	Time	Method
Intra-abdominal bleeding	Up to postoperative 30 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.
Delayed gastric emptying	Up to postoperative 30 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.
Pulmonary complications	Up to postoperative 30 days	Including pulmonary infection and atelectasis.
Length of hospital stay (day)	Up to postoperative 2 weeks	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China