Clinical trial NCT03055676: Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy
Official title: A Randomized Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreaticoduodenectomy
Drainage
Keywords: Pancreaticoduodenectomy
Time of drain removal
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Chinese PLA General Hospital
name: Xuanwu Hospital, Beijing
name: Beijing Chao Yang Hospital
name: Beijing Tongren Hospital
name: Chinese Academy of Medical Sciences
First posted: 2017-02-16
Enrollment: 319
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 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: The sum of grade 2- 4 complications
timeFrame: Up to postoperative 90 days
Secondary outcomes:
measure: Intra-abdominal bleeding
timeFrame: Up to postoperative 90 days
measure: Delayed gastric emptying
timeFrame: Up to postoperative 90 days
measure: Grade B/C complications
timeFrame: Up to postoperative 90 days
measure: Length of hospital stay (day)
timeFrame: Up to postoperative 90 days
measure: Comprehensive complication index (CCI)
timeFrame: Up to postoperative 90 days
measure: Interventional treatment
timeFrame: Up to postoperative 90 days
measure: Total medical expenses
timeFrame: Up to postoperative 90 days
measure: Any other single intem of grade 2-4 complication
timeFrame: Up to postoperative 90 days
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: 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.
citation: 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.
citation: 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.
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.
citation: 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.