External Pancreatic Stent in Pancreaticojejunostomy | NCT06743516

Studies
External Pancreatic Stent in Pancreaticojejunostomy

NCT06743516

Sponsor

Minia University

Status

Recruiting

Last Update Posted

Jun 30, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Pancreatic Fistula

Interventions

Pancreaticojejunostomy with external stent
Pancreaticojejunostomy without external stent

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Sep 1, 2026Estimated

First Submitted Date

Dec 12, 2024

First Submission Date that Met QC Criteria

Dec 16, 2024

First Posted Date

Dec 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2026

Last Update Posted Date

Jun 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.

Detailed Description

The role of external pancreatic duct drainage in managing patients with a soft pancreas is particularly important, as these patients are at a heightened risk of developing postoperative complications. By providing an external route for pancreatic secretions, external pancreatic duct drainage may help to reduce the enzymatic activity at the anastomosis site and promote better healing.

In addition to reducing the incidence of post operative pancreatic fistula, external pancreatic duct drainage may have other potential benefits, such as decreasing the length of hospital stay, reducing the need for additional interventions, and improving overall patient quality of life. However, these potential benefits must be weighed against the risks and drawbacks of external pancreatic duct drainage, including the potential for stent-related complications and the need for an additional procedure to remove the stent.

•After being informed about the study and potential risks, all patients giving written consent. Patients who meet the eligibility requirements will be randomized in a 1:1 ratio to external pancreatic drainage group and no external pancreatic drainage group.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pancreaticojejunostomy with External stent	Active Comparator	ureteric catheter (7Fr) insert at pancreatojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall.	Procedure: Pancreaticojejunostomy with external stent
Pancreaticojejunostomy without stent	Active Comparator	Pancreaticojejunostomy without stent	Procedure: Pancreaticojejunostomy without external stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pancreaticojejunostomy with external stent	Procedure	Inserting ureteric stent at the pancreaticojejunostomy site	Pancreaticojejunostomy with External stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evidence of pancreatic fistula	confirmed by serum and drain amylase	within the first 7 days after surgery( first day, third day and fifth day)

Secondary Outcomes

Measure	Description	Time Frame
evidence of intra abdominal collection	confirmed by abdominal ultrasound and abdominal computed tomography	first week, second week postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing pancreaticoduodenectomy (Whipple procedure) for various indications (e.g., pancreatic cancer, ampullary cancer, etc.).
Patients with a confirmed soft pancreas texture, as determined intraoperatively by the surgeon.

Exclusion Criteria:

Patients with a hard or fibrotic pancreas, as determined intraoperatively by the surgeon.
Patients with severe uncontrolled comorbidities (e.g., uncontrolled diabetes, severe cardiovascular disease, renal failure).
Pregnancy or lactation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Saleh K Khairy, MD	Contact	01201765401	+2	salehkhairy@mu.edu.eg
Anton F Basali, MBBCH	Contact	0102707797	+2	Tony_fayez@yahoo.com

Overall Officials

Name	Affiliation	Role
Saleh K Saleh, MD	Minia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liver and GIT hospital , Minia University	Recruiting	Minya		61519	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D010185	Pancreatic Fistula

Ancestor Terms

ID	Term
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D005402	Fistula

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010193	Pancreaticojejunostomy

Ancestor Terms

ID	Term
D000714	Anastomosis, Surgical
D013514	Surgical Procedures, Operative
D013505	Digestive System Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided