Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

NCT03055676 | Completed DMC

• 1 other identifier: PUMCH-GS05
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreaticoduodenectomy; Drainage

Keywords

Pancreaticoduodenectomy; Time of drain removal

Outcome Measures

Primary Outcomes (1)

• The sum of grade 2- 4 complications

  The severity of complication was measured by Clavein Dindo classifications and grade 2- 4 complications always affect the recovery of the patients significantly.However, the death case (grade 5 complication) is rare now for PD in high volume centers. According to our single center study, early drain removal could reduce the rate of grade 2-4 complications by 12% for the patients undergoing major pancreatectomy.

  Up to postoperative 90 days

Secondary Outcomes (8)

• Intra-abdominal bleeding

  Up to postoperative 90 days

• Delayed gastric emptying

  Up to postoperative 90 days

• Grade B/C complications

  Up to postoperative 90 days

• Length of hospital stay (day)

  Up to postoperative 90 days

• Comprehensive complication index (CCI)

  Up to postoperative 90 days

Study Arms (2)

Early drain removal

EXPERIMENTAL

Removing drain(s) on postoperative day 3 (n = 166)

Other: Early drain removal

Late drain removal

ACTIVE COMPARATOR

Removing drain(s) on postoperative day 5 or later (n = 166)

Other: Late drain removal

Interventions

Early drain removal OTHER

Removing drain(s) on postoperative day 3

Early drain removal

Late drain removal OTHER

Removing drain(s) on postoperative day 5 or later

Late drain removal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Peking University First Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Beijing Chao Yang Hospital: collaborator
• Beijing Tongren Hospital: collaborator
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (7)

• Van Buren G 2nd, Bloomston M, Hughes SJ, Winter J, Behrman SW, Zyromski NJ, Vollmer C, Velanovich V, Riall T, Muscarella P, Trevino J, Nakeeb A, Schmidt CM, Behrns K, Ellison EC, Barakat O, Perry KA, Drebin J, House M, Abdel-Misih S, Silberfein EJ, Goldin S, Brown K, Mohammed S, Hodges SE, McElhany A, Issazadeh M, Jo E, Mo Q, Fisher WE. A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. Ann Surg. 2014 Apr;259(4):605-12. doi: 10.1097/SLA.0000000000000460.

  PMID: 24374513 BACKGROUND

• Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006 Jul;244(1):1-7. doi: 10.1097/01.sla.0000218077.14035.a6.

  PMID: 16794381 BACKGROUND

• Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88.

  PMID: 20622661 BACKGROUND

• 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.

  PMID: 17981197 BACKGROUND

• 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.

  PMID: 16003309 BACKGROUND

• 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.

  PMID: 17629996 BACKGROUND

• Dai M, Liu Q, Xing C, Tian X, Cao F, Tang W, Lv S, Ma Y, Zhang D, Kleeff J, Yang Y, Liu R, He Q, Li F, Li G, Guo J, Liao Q, Zhao Y. Early Drain Removal is Safe in Patients With Low or Intermediate Risk of Pancreatic Fistula After Pancreaticoduodenectomy: A Multicenter, Randomized Controlled Trial. Ann Surg. 2022 Feb 1;275(2):e307-e314. doi: 10.1097/SLA.0000000000004992.

  PMID: 34117153 DERIVED

Study Officials

• Menghua Dai, M.D.

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)