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Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Completed

Conditions

Pancreaticoduodenectomy
Drainage

Treatments

Other: Early drain removal
Other: Late drain removal

Study type

Interventional

Funder types

Other

Identifiers

NCT03055676
PUMCH-GS05

Details and patient eligibility

About

The aim of this randomized prospective multicenter study is to demonstrate the hypothesis that early removal of drain could reduce the incidence of major complications (grade 2-4) after pancreaticoduodenectomy (PD) , when compared with later removal of drain.

Full description

The objective of this randomized prospective multicenter study is to investigate the association between the time of removal of drain after pancreaticoduodenectomy (PD) and incidence of major complications (grade 2-4 complications). The investigators unite six pancreatic surgery center in Beijing. Patients who underwent pancreaticoduodenectomy (PD) or pylorus-preserving pancreaticoduodenectomy (PPPD) with low to moderate risk of post-operative pancreatic fistula (POPF) are recruited into the study. 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 5 or beyond. The primary outcomes are the incidence of sum of grade 2-4 complications, the secondary outcomes include grade B/C POPF, intra-abdominal infeciton, delayed gastric emptying, post-operative bleeding, in-hospital stay, total medical cost and comprehensive complication index (CCI).

Enrollment

319 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. PD with or without pylorus preserving;
  2. Age between 18 and 75 years;
  3. Drain amylase on POD 1 and 3 less than 5000 U/L;
  4. Drain output within POD 3 less than 300 ml per day.

Exclusion criteria

  1. Vascular reconstruction using an artificial graft;
  2. Grade B/ C postoperative bleeding, evident anastomosis leakage within 3 days after surgery;
  3. Refusale to participate in after signed informed consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

319 participants in 2 patient groups

Early drain removal
Experimental group
Description:
Removing drain(s) on postoperative day 3 (n = 166)
Treatment:
Other: Early drain removal
Late drain removal
Active Comparator group
Description:
Removing drain(s) on postoperative day 5 or later (n = 166)
Treatment:
Other: Late drain removal

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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