Pancreatic FistulaNCT06743516
External Pancreatic Stent in Pancreaticojejunostomy
A study testing Pancreaticojejunostomy with external stent and Pancreaticojejunostomy without external stent in people with Pancreatic Fistula, run by Minia University at 1 site in Egypt.
Trial summary
Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Pancreaticojejunostomy with external stent and Pancreaticojejunostomy without external stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Liver and GIT hospital , Minia University
Minya, 61519
Saleh K Saleh, MD, 01201765401 ext. +2, salehkhairy@mu.edu.eg
About this study
Official title: The Impact of External Pancreatic Drainage During Pancreaticojejunostomy Following Pancreaticoduodenectomy in Cases of Soft Pancreas
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.
Read the 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.
- Conditions
- Pancreatic Fistula
- Being tested
- Pancreaticojejunostomy with external stent, Pancreaticojejunostomy without external stent
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaticojejunostomy with external stentProcedure or surgery
Inserting ureteric stent at the pancreaticojejunostomy site
Pancreaticojejunostomy without external stentProcedure or surgery
Only Pancreaticojejunostomy without inserting external stent
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pancreaticojejunostomy with external stent |
| Pancreaticojejunostomy without stent | Active comparator | Pancreaticojejunostomy without stent Receives: Procedure: Pancreaticojejunostomy without external stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
evidence of pancreatic fistula
confirmed by serum and drain amylase
Measured: within the first 7 days after surgery( first day, third day and fifth day)
Secondary outcomes (1)
evidence of intra abdominal collection
confirmed by abdominal ultrasound and abdominal computed tomography
Measured: first week, second week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Khairy Saleh MD, Minia University
- Investigators
- Saleh K Saleh, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743516
- Sponsor's protocol ID
- 1282/10/2024
- Status last verified
- Jun 2026
- First submitted
- 12 Dec 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of External Pancreatic Drainage During Pancreaticojejunostomy Following Pancreaticoduodenectomy in Cases of Soft Pancreas
- ClinicalTrials.gov ID
- NCT06743516
- Acronym / sponsor ID
- 1282/10/2024
- Conditions
- Pancreatic Fistula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreaticojejunostomy with External stent | Active comparator | Procedure: Pancreaticojejunostomy with external stentureteric 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. |
| Pancreaticojejunostomy without stent | Active comparator | Procedure: Pancreaticojejunostomy without external stentPancreaticojejunostomy without stent |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreaticojejunostomy with external stentInserting ureteric stent at the pancreaticojejunostomy site | Procedure or surgery | Pancreaticojejunostomy with External stent |
| Pancreaticojejunostomy without external stentOnly Pancreaticojejunostomy without inserting external stent | Procedure or surgery | Pancreaticojejunostomy without stent |
Primary outcome
evidence of pancreatic fistula
Time frame: within the first 7 days after surgery( first day, third day and fifth day)
confirmed by serum and drain amylase
1 secondary outcome
evidence of intra abdominal collection
Time frame: first week, second week postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saleh K Saleh, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreaticojejunostomy with external stent and Pancreaticojejunostomy without external stent in people with Pancreatic Fistula, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saleh K Khairy, MD (01201765401 ext. +2, salehkhairy@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evidence of pancreatic fistula (time frame: within the first 7 days after surgery( first day, third day and fifth day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.