Clinical trial NCT02230436: Early Versus Late Drain Removal After Pancreatectomy: A Randomized Prospective Trial
Official title: The Impact of Early Versus Late Drain Removal on Postoperative Morbidity After Pancreatectomy: A Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatectomy
Post Procedural Discharge
Keywords: Pancreatectomy
Time of drain removal
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Intra-abdominal infection
timeFrame: Up to postoperative 30 days
measure: Pancreatic fistula
timeFrame: Up to postoperative 30 days
Secondary outcomes:
measure: Intra-abdominal bleeding
timeFrame: Up to postoperative 30 days
measure: Delayed gastric emptying
timeFrame: Up to postoperative 30 days
measure: Pulmonary complications
timeFrame: Up to postoperative 30 days
measure: Length of hospital stay (day)
timeFrame: Up to postoperative 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Menghua Dai, M.D.
role: STUDY_CHAIR
References:
citation: Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005.
citation: Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
citation: Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Buchler MW. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007 Jul;142(1):20-5. doi: 10.1016/j.surg.2007.02.001.