search
Back to results

Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

Primary Purpose

Pancreatectomy, Pancreatic Fistula

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Pancreatic Stenting
No Stent
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatectomy focused on measuring Distal Pancreatectomy, Pancreatic Fistula

Eligibility Criteria

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

Inclusion Criteria:

  • Age >18 years
  • Elective distal pancreatectomy for primary pancreatic pathology

Exclusion Criteria:

  • Informed consent not available
  • Emergency distal pancreatectomy
  • Presence of pancreatic duct stricture
  • Presence of altered anatomy that precludes safe Endoscopic Retrograde Cholangiography (e.g. previous Billroth II gastrectomy)
  • History of severe pancreatitis

Sites / Locations

  • Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pre-op Stenting

Surgery alone

Arm Description

Pre-operative pancreatic stent inserted by Endoscopic Retrograde Cholangiography, followed by distal pancreatectomy

Distal pancreatectomy alone

Outcomes

Primary Outcome Measures

Number of participants with postoperative pancreatic fistula
The number of participants developing post-operative pancreatic fistula, which is defined as drain fluid amylase more than 3 times the upper limit of the normal value of serum amylase on or after postoperative day 3

Secondary Outcome Measures

Number of participants developing post-operative morbidity
Post-operative complications, graded according to the Clavien-Dindo classification, are recorded
Number of participants developing post-operative mortality
All cause mortality after operation was recorded
Total length of hospital stay of participants
The total number of days spent in hospital calculated from the day of admission to discharge for every participant, including the time spent for pre-operative endoscopy and operation
Number of participants developing complications related to Endoscopic Retrograde Cholangiography
All complications occurred after Endoscopic Retrograde Cholangiopancreatography were recorded

Full Information

First Posted
March 3, 2022
Last Updated
March 22, 2022
Sponsor
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT05297136
Brief Title
Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy
Official Title
Preoperative Endoscopic Pancreatic Stent to Prevent Pancreatic Fistula After Distal Pancreatectomy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
March 20, 2026 (Anticipated)
Study Completion Date
May 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

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

5. Study Description

Brief Summary
Distal pancreatectomy (DP) with or without splenectomy is commonly indicated for pancreatic body or tail lesions. Postoperative pancreatic fistula (POPF) remains the commonest complication after DP. A pre-operatively placed pancreatic stent across papilla can decrease the pressure gradient between pancreatic duct and duodenum. Therefore, the pancreatic juice flow is redirected from the pancreatic transection plane and leakage from pancreatic stump is much reduced. This study aims to evaluate whether pre-operatively placed pancreatic stent can prevent POPF by a randomized controlled trial.
Detailed Description
A randomised-controlled trial is performed to evaluate the efficacy of preoperative pancreatic duct stenting in preventing post-operative pancreatic fistula after distal pancreatectomy with or without splenectomy. Patients will be randomised to pre-operative stent group or surgery alone group. Pre-operative pancreatic duct stenting will be performed 1-2 weeks before surgery. The stent will be removed 4 weeks after operation. The post-operative pancreatic fistula rate, morbidity, mortality and total length of stay were compared between the 2 groups.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pre-op Stenting
Arm Type
Experimental
Arm Description
Pre-operative pancreatic stent inserted by Endoscopic Retrograde Cholangiography, followed by distal pancreatectomy
Arm Title
Surgery alone
Arm Type
Active Comparator
Arm Description
Distal pancreatectomy alone
Intervention Type
Procedure
Intervention Name(s)
Pancreatic Stenting
Intervention Description
Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy
Intervention Type
Procedure
Intervention Name(s)
No Stent
Intervention Description
No preoperative stenting with distal pancreatectomy alone
Primary Outcome Measure Information:
Title
Number of participants with postoperative pancreatic fistula
Description
The number of participants developing post-operative pancreatic fistula, which is defined as drain fluid amylase more than 3 times the upper limit of the normal value of serum amylase on or after postoperative day 3
Time Frame
Day 3 after operation
Secondary Outcome Measure Information:
Title
Number of participants developing post-operative morbidity
Description
Post-operative complications, graded according to the Clavien-Dindo classification, are recorded
Time Frame
90 days
Title
Number of participants developing post-operative mortality
Description
All cause mortality after operation was recorded
Time Frame
90 days
Title
Total length of hospital stay of participants
Description
The total number of days spent in hospital calculated from the day of admission to discharge for every participant, including the time spent for pre-operative endoscopy and operation
Time Frame
90 days after endoscopy and operation
Title
Number of participants developing complications related to Endoscopic Retrograde Cholangiography
Description
All complications occurred after Endoscopic Retrograde Cholangiopancreatography were recorded
Time Frame
14 days after endoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 years Elective distal pancreatectomy for primary pancreatic pathology Exclusion Criteria: Informed consent not available Emergency distal pancreatectomy Presence of pancreatic duct stricture Presence of altered anatomy that precludes safe Endoscopic Retrograde Cholangiography (e.g. previous Billroth II gastrectomy) History of severe pancreatitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kit Fai Lee, MBBS
Phone
35051496
Email
leekf@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kit Fai Lee, MBBS
Organizational Affiliation
Clinical Associate Professor (honorary)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kit Fai Lee, MBBS
Phone
35051496
Email
leekf@surgery.cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

We'll reach out to this number within 24 hrs