NCT02230436

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

August 1, 2016

Enrollment Period

3 years

First QC Date

August 16, 2014

Last Update Submit

February 20, 2017

Conditions

PancreatectomyPost Procedural Discharge

Keywords

PancreatectomyTime of drain removal

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Intra-abdominal bleeding

    Up to postoperative 30 days

  • Delayed gastric emptying

    Up to postoperative 30 days

  • Pulmonary complications

    Up to postoperative 30 days

  • Length of hospital stay (day)

    Up to postoperative 2 weeks

Study Arms (2)

Early drain removal

EXPERIMENTAL

Removing drain(s) on postoperative day 3 (n = 72)

Other: Early drain removal

Late drain removal

EXPERIMENTAL

Removing drain(s) on postoperative day 4 or later (n = 72)

Other: Late drain removal

Interventions

Early drain removalOTHER

Removing drain(s) on postoperative day 3

Early drain removal
Late drain removalOTHER

Removing drain(s) on postoperative day 4 or later

Late drain removal

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Related Publications (3)

  • 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: 17981197BACKGROUND

  • 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: 16003309BACKGROUND

  • 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: 17629996BACKGROUND

Study Officials

  • Menghua Dai, M.D.

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Menghua Dai, M.D.

CONTACT

daim66@126.com

Ning Shi, M.D.

CONTACT

8613693303585shining_doc@163.com

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

August 16, 2014

First Posted

September 3, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

February 23, 2017

Record last verified: 2016-08

Locations

CN(1)