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2025-09-15
2028-09-15
2028-11-15
194
NCT07155525
Minia University
Minia University
INTERVENTIONAL
Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-08-27 | N/A | 2025-09-14 |
2025-09-03 | N/A | 2025-09-18 |
2025-09-04 | N/A | 2025-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 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. | DRUG: Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)
|
| ACTIVE_COMPARATOR: Standard Pancreaticojejunostomy without tissue adhesive application. Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy. | PROCEDURE: Standard(duct-to-mucosa) Pancreaticojejunostomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 30 days post-surgery. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Time to POPF resolution. | Number of days from surgery to complete resolution of pancreatic fistula. | 90 days post-surgery. |
| Postoperative complications | Incidence of delayed gastric emptying, bile leak, wound infection, intra-abdominal abscess, and other complications. | 30 days post-surgery |
| Reoperation Rate | Percentage of patients requiring reoperation for complications. | 90 days post-surgery. |
| Length of Hospital Stay | Total number of days in hospital following surgery(days). | Up to 90 days |
| Incidence of postpancreatectomy Hemorrhage | Per International Study Group on Pancreatic Fistula (ISGPS) criteria. | 30 days post-surgery |
| Mortality Rate | All-cause mortality. | 90 days post-surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Saleh K Saleh, MD Phone Number: +201201765401 Email: salehkhairy@mu.edu.eg |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
