Pancreatic CancerNBCA-MSNCT07155525
Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
A study testing Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) and Standard(duct-to-mucosa) Pancreaticojejunostomy in people with Pancreatic Cancer and Periampullary Cancer, run by Minia University at 1 site in Egypt.
Trial summary
This is a single-center, randomized controlled trial comparing the efficacy of pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate(Glubran® 2) versus standard pancreaticojejunostomy without cyanoacrylate in preventing postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Periampullary Cancer, Duodenal Cancer
- What is being tested?
- Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) and Standard(duct-to-mucosa) Pancreaticojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to 15 Nov 2028
- 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 scheduled for elective pancreaticoduodenectomy for malignant lesions.
- Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas).
- Age 18-75 years .
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate organ function defined as:
- Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count ≥ 1,500/μL Platelet count ≥ 100,000/μL Total bilirubin ≤ 3 times upper limit of normal Alanine transaminase (ALT) /Alanine transaminase (ALT)( ≤ 5 times upper limit of normal Serum creatinine ≤ 1.5 times upper limit of normal
- Informed consent provided.
- Willingness to comply with study procedures and follow-up requirements.
Who cannot join
- Hard pancreatic texture (intraoperative surgeon assessment).
- Emergency surgery.
- Previous pancreatic surgery or pancreatic anastomosis.
- Intraoperative identification of unresectable disease
- Known allergy to cyanoacrylate or components.
- Pregnancy or lactation.
- Active infection or sepsis.
- Inability to comply with follow-up.
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, Minya Governorate, 61519
Saleh K Saleh, MD, +201201765401 ext. +2, salehkhairy@mu.edu.eg
About this study
Official title: Pancreaticojejunostomy With or Without Modified N-butyl-2-cyanoacrylate Following Pancreaticoduodenectomy in Soft Pancreas: Randomized Controlled Trial
This is a single-center, randomized controlled trial comparing the efficacy of pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate(Glubran® 2) versus standard pancreaticojejunostomy without cyanoacrylate in preventing postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy with soft pancreatic texture. The primary endpoint is the incidence of postoperative pancreatic fistula at 30 days post-surgery, as defined by the International Study Group on Pancreatic Fistula (ISGPF) criteria.Secondary outcomes include surgical complications and length of hospital stay. The study will enroll approximately 194 patients at a single center.
Read the detailed description
Postoperative pancreatic fistula (POPF) remains the most common and serious complication following pancreaticoduodenectomy, with incidence rates reaching up to 56.7% in patients with soft pancreatic texture. The soft pancreatic parenchyma is particularly vulnerable to anastomotic breakdown due to its friable nature and difficulty in achieving secure suturing.
N-butyl-2-cyanoacrylate is a biodegradable tissue adhesive that polymerizes rapidly upon contact with hydroxide ions in tissue fluids, forming a strong, flexible bond. The application of modified N-butyl-2-cyanoacrylate to pancreaticoenteric anastomoses may reduce the incidence of POPF by providing additional mechanical reinforcement and sealing of minor leaks.
This is a phase III, single-center, prospective, randomized controlled trial with parallel groups. Eligible patients will undergo intraoperative assessment of pancreatic texture (soft confirmed by surgeon's palpation). Randomization will occur intraoperatively after resection but before reconstruction, using computer-generated blocks.
This study aims to evaluate whether the application of modified N-butyl-2-cyanoacrylate (Glubran® 2) during pancreaticojejunostomy can significantly reduce the incidence of POPF in patients with soft pancreatic texture undergoing pancreaticoduodenectomy. Patients will be randomized to receive either standard pancreaticojejunostomy (control group) or pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate application (intervention group).
The intervention group will receive 1-2 mL of modified N-butyl-2-cyanoacrylate applied topically to the pancreatic stump and anastomosis site during pancreaticojejunostomy. The control group will receive standard duct-to-mucosa pancreaticojejunostomy without adhesive. All patients will receive standardized perioperative care, including prophylactic antibiotics and drain management per ISGPF guidelines.
Follow-up will include daily amylase measurements in drains (days 1,3,5), CT imaging if POPF suspected.
- Conditions
- Pancreatic Cancer, Periampullary Cancer, Duodenal Cancer, Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Head Mass
- Being tested
- Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2), Standard(duct-to-mucosa) Pancreaticojejunostomy
- Keywords
- Pancreaticoduodenectomy, Pancreaticojejunostomy, Postoperative Pancreatic Fistula, Soft Pancreas, N-Butyl-2-Cyanoacrylate, Whipple procedure, Tissue adhesive, POPF prevention
- Medical subject headings
- Pancreatic Neoplasms, Duodenal Neoplasms, Cholangiocarcinoma, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)Drug
Also called Tissue Adhesive, Cyanoacrylate Glue,Glubran® 2
- Standard duct-to-mucosa pancreaticojejunostomy performed
- Application of 0.5-1.0 mL modified N-butyl-2-cyanoacrylate around the anastomotic site
- Adhesive applied circumferentially around the pancreaticojejunal anastomosis
- Allow 2-3 minutes for polymerization before proceeding
- Standard placement of peritoneal drains
Standard(duct-to-mucosa) PancreaticojejunostomyProcedure or surgery
Also called Standard Pancreaticojejunostomy
- Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy.
- Standard placement of peritoneal drains
- All other aspects of surgical care identical to experimental arm
| Study group | Role | What they receive |
|---|---|---|
| Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) | Experimental | Patients undergo standard duct-to-mucosa pancreaticojejunostomy with topical application of 1-2 mL modified N-butyl-2-cyanoacrylate to the anastomotic site and surrounding pancreatic parenchyma. Receives: Drug: Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) |
| Standard Pancreaticojejunostomy without tissue adhesive application. | Active comparator | Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy. Receives: Procedure: Standard(duct-to-mucosa) Pancreaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Pancreatic Fistula (POPF).
Percentage of patients developing postoperative pancreatic fistula as defined by International Study Group on Pancreatic Fistula (ISGPF) criteria. POPF is defined as drain output of any measurable volume of fluid on or after postoperative day 3 with amylase content greater than 3 times the upper normal serum value. Graded as A (biochemical leak), B , or C.
Measured: 30 days post-surgery.
Secondary outcomes (6)
Time to POPF resolution.
Number of days from surgery to complete resolution of pancreatic fistula.
Measured: 90 days post-surgery.
Postoperative complications
Incidence of delayed gastric emptying, bile leak, wound infection, intra-abdominal abscess, and other complications.
Measured: 30 days post-surgery
Reoperation Rate
Percentage of patients requiring reoperation for complications.
Measured: 90 days post-surgery.
Length of Hospital Stay
Total number of days in hospital following surgery(days).
Measured: Up to 90 days
Incidence of postpancreatectomy Hemorrhage
Per International Study Group on Pancreatic Fistula (ISGPS) criteria.
Measured: 30 days post-surgery
Mortality Rate
All-cause mortality.
Measured: 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start15 Sep 2025
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 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
- NCT07155525
- Sponsor's protocol ID
- 1319/10/2024
- Acronym
- NBCA-MS
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
PubMed 28040257Gaspar AF, Kemp R, Sankarankutty AK, Lopes Junior JR, Filho JAF, Avezum VAPAF, de Assis Mota G, Nunes AA, Dos Santos JS. Influence on Postoperative Results and Cost-effectiveness of Using Cyanoacrylate Glue for Pancreaticojejunal Anastomosis After Duodenopancreatectomy. Pancreas. 2025 Aug 1;54(7):e610-e617. doi: 10.1097/MPA.0000000000002479.
PubMed 40127250
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreaticojejunostomy With or Without Modified N-butyl-2-cyanoacrylate Following Pancreaticoduodenectomy in Soft Pancreas: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07155525
- Acronym / sponsor ID
- NBCA-MS / 1319/10/2024
- Conditions
- Pancreatic Cancer, Periampullary Cancer, Duodenal Cancer, Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Head Mass
- Keywords
- Pancreaticoduodenectomy, Pancreaticojejunostomy, Postoperative Pancreatic Fistula, Soft Pancreas, N-Butyl-2-Cyanoacrylate, Whipple procedure, Tissue adhesive, POPF prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 4 Sep 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.
This is a single-center, randomized controlled trial comparing the efficacy of pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate(Glubran® 2) versus standard pancreaticojejunostomy without cyanoacrylate in preventing postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy with soft pancreatic texture. The primary endpoint is the incidence of postoperative pancreatic fistula at 30 days post-surgery, as defined by the International Study Group on Pancreatic Fistula (ISGPF) criteria.Secondary outcomes include surgical complications and length of hospital stay. The study will enroll approximately 194 patients at a single center.
Detailed description
Postoperative pancreatic fistula (POPF) remains the most common and serious complication following pancreaticoduodenectomy, with incidence rates reaching up to 56.7% in patients with soft pancreatic texture. The soft pancreatic parenchyma is particularly vulnerable to anastomotic breakdown due to its friable nature and difficulty in achieving secure suturing.
N-butyl-2-cyanoacrylate is a biodegradable tissue adhesive that polymerizes rapidly upon contact with hydroxide ions in tissue fluids, forming a strong, flexible bond. The application of modified N-butyl-2-cyanoacrylate to pancreaticoenteric anastomoses may reduce the incidence of POPF by providing additional mechanical reinforcement and sealing of minor leaks.
This is a phase III, single-center, prospective, randomized controlled trial with parallel groups. Eligible patients will undergo intraoperative assessment of pancreatic texture (soft confirmed by surgeon's palpation). Randomization will occur intraoperatively after resection but before reconstruction, using computer-generated blocks.
This study aims to evaluate whether the application of modified N-butyl-2-cyanoacrylate (Glubran® 2) during pancreaticojejunostomy can significantly reduce the incidence of POPF in patients with soft pancreatic texture undergoing pancreaticoduodenectomy. Patients will be randomized to receive either standard pancreaticojejunostomy (control group) or pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate application (intervention group).
The intervention group will receive 1-2 mL of modified N-butyl-2-cyanoacrylate applied topically to the pancreatic stump and anastomosis site during pancreaticojejunostomy. The control group will receive standard duct-to-mucosa pancreaticojejunostomy without adhesive. All patients will receive standardized perioperative care, including prophylactic antibiotics and drain management per ISGPF guidelines.
Follow-up will include daily amylase measurements in drains (days 1,3,5), CT imaging if POPF suspected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) | Experimental | Drug: Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)Patients undergo standard duct-to-mucosa pancreaticojejunostomy with topical application of 1-2 mL modified N-butyl-2-cyanoacrylate to the anastomotic site and surrounding pancreatic parenchyma. |
| Standard Pancreaticojejunostomy without tissue adhesive application. | Active comparator | Procedure: Standard(duct-to-mucosa) PancreaticojejunostomyPatients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients scheduled for elective pancreaticoduodenectomy for malignant lesions.
- Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas).
- Age 18-75 years .
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate organ function defined as:
Key exclusion criteria (8 listed)
- Hard pancreatic texture (intraoperative surgeon assessment).
- Emergency surgery.
- Previous pancreatic surgery or pancreatic anastomosis.
- Intraoperative identification of unresectable disease
- Known allergy to cyanoacrylate or components.
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 Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)Also: Tissue Adhesive, Cyanoacrylate Glue,Glubran® 2* Standard duct-to-mucosa pancreaticojejunostomy performed * Application of 0.5-1.0 mL modified N-butyl-2-cyanoacrylate around the anastomotic site * Adhesive applied circumferentially around the pancreaticojejunal anastomosis * Allow 2-3 minutes for polymerization before proceeding * Standard placement of peritoneal drains | Drug | Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) |
| Standard(duct-to-mucosa) PancreaticojejunostomyAlso: Standard Pancreaticojejunostomy* Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy. * Standard placement of peritoneal drains * All other aspects of surgical care identical to experimental arm | Procedure or surgery | Standard Pancreaticojejunostomy without tissue adhesive application. |
Primary outcome
Incidence of Postoperative Pancreatic Fistula (POPF).
Time frame: 30 days post-surgery.
Percentage of patients developing postoperative pancreatic fistula as defined by International Study Group on Pancreatic Fistula (ISGPF) criteria. POPF is defined as drain output of any measurable volume of fluid on or after postoperative day 3 with amylase content greater than 3 times the upper normal serum value. Graded as A (biochemical leak), B , or C.
6 secondary outcomes
Time to POPF resolution.
Time frame: 90 days post-surgery.
Postoperative complications
Time frame: 30 days post-surgery
Reoperation Rate
Time frame: 90 days post-surgery.
Length of Hospital Stay
Time frame: Up to 90 days
Incidence of postpancreatectomy Hemorrhage
Time frame: 30 days post-surgery
Mortality Rate
Time frame: 90 days post-surgery
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 1 Oct 2026.
- Results publication: PubMed 28040257Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
- Results publication: PubMed 40127250Gaspar AF, Kemp R, Sankarankutty AK, Lopes Junior JR, Filho JAF, Avezum VAPAF, de Assis Mota G, Nunes AA, Dos Santos JS. Influence on Postoperative Results and Cost-effectiveness of Using Cyanoacrylate Glue for Pancreaticojejunal Anastomosis After Duodenopancreatectomy. Pancreas. 2025 Aug 1;54(7):e610-e617. doi: 10.1097/MPA.0000000000002479.
- 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 study testing Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) and Standard(duct-to-mucosa) Pancreaticojejunostomy in people with Pancreatic Cancer and Periampullary 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 8 inclusion and 8 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 1 Oct 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 Saleh, MD (+201201765401 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?
Incidence of Postoperative Pancreatic Fistula (POPF). (time frame: 30 days post-surgery.). 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 NCT07155525, which also lists 2 linked publications.
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 1 Oct 2026.