search
Back to results

Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula

Primary Purpose

Pancreatic Fistula

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prophylactic pancreatic stent
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatic Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients scheduled for elective segmental pancreatectomy

Exclusion Criteria:

  • 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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stent

No stent

Arm Description

Prophylactic pancreatic stent before segmental pancreatic surgery

No prophylactic stent before surgery

Outcomes

Primary Outcome Measures

Postoperative pancreatic fistula
Grade B and C

Secondary Outcome Measures

Severity of pancreatic fistula
Grade B POPF requires changes in clinical management, such as persistent drainage, partial or total parenteral nutrition, antibiotics, enteral nutrition, somatostatin analogs, and/or minimal invasive drainage. Grade C POPF requires major changes in management, such as admission to an intensive care unit, reoperation, and/or an extended hospital stay.
Length of stay
Length of hospital stay

Full Information

First Posted
January 28, 2019
Last Updated
January 28, 2019
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03822676
Brief Title
Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula
Official Title
Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula Before Segmental Pancreatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Fistula

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stent
Arm Type
Experimental
Arm Description
Prophylactic pancreatic stent before segmental pancreatic surgery
Arm Title
No stent
Arm Type
No Intervention
Arm Description
No prophylactic stent before surgery
Intervention Type
Device
Intervention Name(s)
Prophylactic pancreatic stent
Intervention Description
Prophylactic pancreatic stent before segmental pancreatic surgery
Primary Outcome Measure Information:
Title
Postoperative pancreatic fistula
Description
Grade B and C
Time Frame
from postoperative day 3 to 30
Secondary Outcome Measure Information:
Title
Severity of pancreatic fistula
Description
Grade B POPF requires changes in clinical management, such as persistent drainage, partial or total parenteral nutrition, antibiotics, enteral nutrition, somatostatin analogs, and/or minimal invasive drainage. Grade C POPF requires major changes in management, such as admission to an intensive care unit, reoperation, and/or an extended hospital stay.
Time Frame
from postoperative day 3 to 30
Title
Length of stay
Description
Length of hospital stay
Time Frame
from postoperative day 1 to discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients scheduled for elective segmental pancreatectomy Exclusion Criteria: 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
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiming Yang, M.D.
Phone
+86-10-69151593
Email
yangaiming@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Yunlu Feng, M.D.

12. IPD Sharing Statement

Learn more about this trial

Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula

We'll reach out to this number within 24 hrs