Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial

Official title:

A Randomized Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055676
• Other study ID #: PUMCH-GS05
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: April 2020

Study information

• Verified date: April 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: April 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drainage
• Pancreaticoduodenectomy

Intervention

Other:
• Early drain removal
Removing drain(s) on postoperative day 3
• Late drain removal
Removing drain(s) on postoperative day 5 or later

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (7)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Chao Yang Hospital, Beijing Tongren Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Peking University First Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Review. — View 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. — View 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. — View 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. — View Citation

Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Büchler 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. — View Citation

Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Büchler MW. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007 Jul;142(1):20-5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intra-abdominal bleeding	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.	Up to postoperative 90 days
Secondary	Delayed gastric emptying	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.	Up to postoperative 90 days
Secondary	Grade B/C complications	The International Study Group of Pancreatic Surgery (ISGPS) definition	Up to postoperative 90 days
Secondary	Length of hospital stay (day)	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.	Up to postoperative 90 days
Secondary	Comprehensive complication index (CCI)	integrates all complications of the Clavien-Dindo classification (CDC) and offers a metric approach to measure morbidity.	Up to postoperative 90 days
Secondary	Interventional treatment	interventional treatment for any complication.	Up to postoperative 90 days
Secondary	Total medical expenses	Total medical expenses during hospitalization.	Up to postoperative 90 days
Secondary	Any other single intem of grade 2-4 complication	Clavein Dindo Classification is adopted.	Up to postoperative 90 days