Early Versus Late Drain Removal After Pancreatectomy: A Randomized Prospective Trial

Pancreatectomy Clinical Trial

Official title:

The Impact of Early Versus Late Drain Removal on Postoperative Morbidity After Pancreatectomy: A Randomized Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02230436
• Other study ID #: PUMCH-GS02
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2014
• Last updated: February 20, 2017
• Start date: July 2014
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Peking Union Medical College Hospital
• Contact: Menghua Dai, M.D.
• Email: daim66[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatectomy
• Post Procedural Discharge

Intervention

Other:
• Early drain removal
Removing drain(s) on postoperative day 3
• Late drain removal
Removing drain(s) on postoperative day 4 or later

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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

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	Intra-abdominal infection	Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.	Up to postoperative 30 days
Primary	Pancreatic fistula	The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.	Up to postoperative 30 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 30 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 30 days
Secondary	Pulmonary complications	Including pulmonary infection and atelectasis.	Up to postoperative 30 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 2 weeks