NCT03822676

Brief Summary

Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. However, the results of prospective RCTs for the prophylactic effect of pancreatic stent insertion against POPF were controversial. This single center prospective randomized trial was designed to compare the outcome after segmental pancreatectomy with prophylactic drainage stent versus no stent.

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
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 22, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

January 28, 2019

Last Update Submit

January 28, 2019

Conditions

Pancreatic Fistula

Outcome Measures

Primary Outcomes (1)

  • Postoperative pancreatic fistula

    Grade B and C

    from postoperative day 3 to 30

Secondary Outcomes (2)

  • Severity of pancreatic fistula

    from postoperative day 3 to 30

  • Length of stay

    from postoperative day 1 to discharge

Study Arms (2)

Stent

EXPERIMENTAL

Prophylactic pancreatic stent before segmental pancreatic surgery

Device: Prophylactic pancreatic stent

No stent

NO INTERVENTION

No prophylactic stent before surgery

Interventions

Prophylactic pancreatic stentDEVICE

Prophylactic pancreatic stent before segmental pancreatic surgery

Stent

Eligibility Criteria

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

You may qualify if:

  • All patients scheduled for elective segmental pancreatectomy

You may not qualify if:

  • Subjects for whom ERCP procedures are contraindicated
  • If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
  • Age less than 18 year
  • Emergency surgery
  • Previous pancreatic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 30, 2019

Study Start

January 22, 2019

Primary Completion

December 1, 2021

Study Completion

May 1, 2022

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations

CN(1)