Pancreatic FistulaPhase 2NCT06756074
Reinforced Pancreaticojejunostomy With or Without glubran2
A Phase 2 study testing Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) and Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) in people with Pancreatic Fistula and Pancreas Cancer, 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 different techniques in pancreatojejunostomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Fistula, Pancreas Cancer, Periampullary Carcinoma
- What is being tested?
- Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) and Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2025to 15 May 2026
- Phase
- Phase 2
- 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
- All the patients undergoing pancreaticoduodenectomy for cancer
- Patients able to give their informed consent
Who cannot join
- Unfit patients for surgery due to severe medical illness.
- Inoperable patients by imaging studies, irresectable tumors after laparotomy or diagnostic laparoscopy.
- Presence of distant metastasis .
- Patients refused to participate in the study.
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: Impact of Reinforced Pancreaticojejunostomy With or Without Tissue Adhesive Glue Modified Cyanoacrylate (Glubran 2) Following Pancreaticoduodenectomy, Randomized Controlled Clinical Trial.
Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend different techniques in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula by enforce pancreaticojejunostomy with tissue glue .
Read the detailed description
Tissue adhesives have gained popularity in various fields of surgical practice. There are various types of tissue adhesives, each with their own adhesive mechanisms and uses. Basically, a tissue adhesive forms bonds with its substrate, ensuring sufficient adhesion. These bonds can either be chemical, of which covalent bonds are the strongest, or physical, including hydrogen bonds or van der Waals forces. Furthermore, the total strength of the glue bond depends on the balance between interaction within the tissue adhesive (cohesion) and between the tissue adhesive-substrate interface (adhesion). Tissue adhesives can either be glues, intended to independently connect various structures (i.e., wound edges), or sealants, used to cover and protect an anastomosis .
Except for external use, tissue adhesives can also be used intracorporeally. Various tissue adhesives are being used in cardiovascular surgery, plastic surgery, and, increasingly, surgery of the GI tract .
Tissue adhesives are promising tools for wound closure. They distribute forces throughout the wound more evenly and noninvasively than sutures and staples, are strong and flexible, and do not interfere with the wound-healing process. Also, the technique of tissue adhesive application to the wound is easy and standardizable, resulting in less variation in technique between surgeons .
By using tissue adhesives as sealants of GI anastomosis, enhancing standard anastomotic techniques. Numerous research projects have been undertaken to assess the applicability of available tissue adhesives in GI surgery; however, no recent literature provides the surgical community with an up-to-date overview of the progress in this field .
•After being informed about the study and potential risks, all patients giving written consent. Eligible patients were randomly assigned in a 1:1 ratio to either the Glubran®2 group (Group A) or the Control group (Group B) using a computer-generated randomization sequence with permuted blocks of 4 and 6. Allocation concealment was ensured using serially numbered, opaque, sealed envelopes prepared by an independent statistician. Each envelope was opened by the scrub nurse or anesthesiologist immediately after the completion of the pancreaticojejunostomy anastomosis, before final hemostasis and abdominal closure
- Conditions
- Pancreatic Fistula, Pancreas Cancer, Periampullary Carcinoma, Pancreatic Ductal Adenocarcinoma
- Being tested
- Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2), Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)
- Medical subject headings
- Pancreatic Fistula, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)Drug
pancreaticojejunostomy was done with application of glubran 2: The blister pack was opened, and the sterile single-dose vial was released directly onto the operating table in a sterile environment, Draw the Glubran 2 out of the single-dose vial using a sterile syringe then put the syringe into applicator Glubran 2 was applied into anastomosis by applicator in spraying manner . Whenever possible, the area to be treated should be cleaned before application. When applied in such a minimal amount, once it had polymerized, Glubran 2 formed a thin adhesive layer. It was therefore essential not to apply more than one drop in the same point. A second layer of Glubran 2 may not be applied until the first had polymerized. Any excess product was removed using a dry swab within 5-6 seconds after application. Glubran 2 was not touched after application until the polymerization reaction is complete, as it may detach or not produce the desired effect.
Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)Procedure or surgery
Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)
| Study group | Role | What they receive |
|---|---|---|
| Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) | Experimental | Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) Receives: Drug: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) |
| Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) | Active comparator | Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) Receives: Procedure: Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of Postoperative pancreatic fistula within 2 weeks after operation
Postoperative pancreatic fistula (POPF) is defined as a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity.
Measured: within 2 weeks after operation
Secondary outcomes (12)
Post-Pancreatectomy Hemorrhage
As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Measured: 90 days
Delayed Gastric Emptying
As defined by ISGPS, grade A, B and C rates
Measured: 90 days
Biliary fistula
Output of bile from drains on or by post operative day 3, pancreaticojejunostomy leak should be ruled out
Measured: 90 days
Abdominal abscess
Collection >5cm in size, containing gas bubbles, determining systemic signs of infection
Measured: 90 days
Acute pancreatitis
Altered serum amylase count on post operative day 0 or 1
Measured: 1 day post index surgery
Wound infection
Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention
Measured: 90 days
Blood transfusions
Need and number of packed red blood cells transfused
Measured: 90 days
Reoperation
Need for new surgery due to severe morbidity
Measured: 90 days
Readmission
New admission within 30-days of discharge from hospital
Measured: 30 days after hospital discharge
Length of Hospital Stay
calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission
Measured: 1 year
Mortality
Death related to surgical morbidity
Measured: 90 days
Removal time of drain
The timing of removal of the drain tube is determined based on the time of removal of the last drain tube. The removal of the drain tube is assessed at the discretion of the surgeon.
Measured: From date of surgery until the date of the last drainage removal, whichever came first, assessed up to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start15 Jan 2025
- Primary completion15 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, 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
- NCT06756074
- Sponsor's protocol ID
- 1350/11/2024
- Status last verified
- Mar 2026
- First submitted
- 24 Dec 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saleh SK, Farahat MS, Mohamed TA, Hendy MM. Impact of reinforced pancreaticojejunostomy with or without tissue adhesive glue modified cyanoacrylate following pancreaticoduodenectomy: a randomized controlled clinical trial. World J Surg Oncol. 2026 Jun 30;24(1):268. doi: 10.1186/s12957-026-04476-3.
PubMed 42381068
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reinforced Pancreaticojejunostomy With or Without Tissue Adhesive Glue Modified Cyanoacrylate (Glubran 2) Following Pancreaticoduodenectomy, Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06756074
- Acronym / sponsor ID
- 1350/11/2024
- Conditions
- Pancreatic Fistula, Pancreas Cancer, Periampullary Carcinoma, Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 1 Jan 2025 (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 different techniques in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula by enforce pancreaticojejunostomy with tissue glue .
Detailed description
Tissue adhesives have gained popularity in various fields of surgical practice. There are various types of tissue adhesives, each with their own adhesive mechanisms and uses. Basically, a tissue adhesive forms bonds with its substrate, ensuring sufficient adhesion. These bonds can either be chemical, of which covalent bonds are the strongest, or physical, including hydrogen bonds or van der Waals forces. Furthermore, the total strength of the glue bond depends on the balance between interaction within the tissue adhesive (cohesion) and between the tissue adhesive-substrate interface (adhesion). Tissue adhesives can either be glues, intended to independently connect various structures (i.e., wound edges), or sealants, used to cover and protect an anastomosis .
Except for external use, tissue adhesives can also be used intracorporeally. Various tissue adhesives are being used in cardiovascular surgery, plastic surgery, and, increasingly, surgery of the GI tract .
Tissue adhesives are promising tools for wound closure. They distribute forces throughout the wound more evenly and noninvasively than sutures and staples, are strong and flexible, and do not interfere with the wound-healing process. Also, the technique of tissue adhesive application to the wound is easy and standardizable, resulting in less variation in technique between surgeons .
By using tissue adhesives as sealants of GI anastomosis, enhancing standard anastomotic techniques. Numerous research projects have been undertaken to assess the applicability of available tissue adhesives in GI surgery; however, no recent literature provides the surgical community with an up-to-date overview of the progress in this field .
•After being informed about the study and potential risks, all patients giving written consent. Eligible patients were randomly assigned in a 1:1 ratio to either the Glubran®2 group (Group A) or the Control group (Group B) using a computer-generated randomization sequence with permuted blocks of 4 and 6. Allocation concealment was ensured using serially numbered, opaque, sealed envelopes prepared by an independent statistician. Each envelope was opened by the scrub nurse or anesthesiologist immediately after the completion of the pancreaticojejunostomy anastomosis, before final hemostasis and abdominal closure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) | Experimental | Drug: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) |
| Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) | Active comparator | Procedure: Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All the patients undergoing pancreaticoduodenectomy for cancer
- Patients able to give their informed consent
Key exclusion criteria (4 listed)
- Unfit patients for surgery due to severe medical illness.
- Inoperable patients by imaging studies, irresectable tumors after laparotomy or diagnostic laparoscopy.
- Presence of distant metastasis .
- Patients refused to participate in the study.
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 |
|---|---|---|
| Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)pancreaticojejunostomy was done with application of glubran 2: The blister pack was opened, and the sterile single-dose vial was released directly onto the operating table in a sterile environment, Draw the Glubran 2 out of the single-dose vial using a sterile syringe then put the syringe into applicator Glubran 2 was applied into anastomosis by applicator in spraying manner . Whenever possible, the area to be treated should be cleaned before application. When applied in such a minimal amount, once it had polymerized, Glubran 2 formed a thin adhesive layer. It was therefore essential not to apply more than one drop in the same point. A second layer of Glubran 2 may not be applied until the first had polymerized. Any excess product was removed using a dry swab within 5-6 seconds after application. Glubran 2 was not touched after application until the polymerization reaction is complete, as it may detach or not produce the desired effect. | Drug | Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) |
| Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) | Procedure or surgery | Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) |
Primary outcome
the rate of Postoperative pancreatic fistula within 2 weeks after operation
Time frame: within 2 weeks after operation
Postoperative pancreatic fistula (POPF) is defined as a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity.
12 secondary outcomes
Post-Pancreatectomy Hemorrhage
Time frame: 90 days
Delayed Gastric Emptying
Time frame: 90 days
Biliary fistula
Time frame: 90 days
Abdominal abscess
Time frame: 90 days
Acute pancreatitis
Time frame: 1 day post index surgery
Wound infection
Time frame: 90 days
Blood transfusions
Time frame: 90 days
Reoperation
Time frame: 90 days
Readmission
Time frame: 30 days after hospital discharge
Length of Hospital Stay
Time frame: 1 year
Mortality
Time frame: 90 days
Removal time of drain
Time frame: From date of surgery until the date of the last drainage removal, whichever came first, assessed up to study completion, an average of 1 year
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 16 Mar 2026.
- Derived from this study: PubMed 42381068Saleh SK, Farahat MS, Mohamed TA, Hendy MM. Impact of reinforced pancreaticojejunostomy with or without tissue adhesive glue modified cyanoacrylate following pancreaticoduodenectomy: a randomized controlled clinical trial. World J Surg Oncol. 2026 Jun 30;24(1):268. doi: 10.1186/s12957-026-04476-3.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) and Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) in people with Pancreatic Fistula and Pancreas Cancer, 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 4 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 16 Mar 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Saleh, 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?
the rate of Postoperative pancreatic fistula within 2 weeks after operation (time frame: within 2 weeks after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06756074, which also lists 1 linked publication.
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 16 Mar 2026.