Bile Duct Cancer, Cholangiocarcinoma, Duodenal Cancer, Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Pancreatic Head Mass, Periampullary Cancer
Conditions
Keywords
Pancreaticoduodenectomy, Pancreaticojejunostomy, Postoperative Pancreatic Fistula, Soft Pancreas, N-Butyl-2-Cyanoacrylate, Whipple procedure, Tissue adhesive, POPF prevention
Brief 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 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.
Interventions
DRUGPancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (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
PROCEDUREStandard(duct-to-mucosa) 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
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The operating surgeon and patient cannot be blinded due to the nature of the intervention. However, outcome assessors, including radiologists reviewing imaging studies and physicians evaluating postoperative complications, will be blinded to treatment allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Pancreatic Fistula (POPF). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 30 days post-surgery | Incidence of delayed gastric emptying, bile leak, wound infection, intra-abdominal abscess, and other complications. |
| Reoperation Rate | 90 days post-surgery. | Percentage of patients requiring reoperation for complications. |
| Time to POPF resolution. | 90 days post-surgery. | Number of days from surgery to complete resolution of pancreatic fistula. |
| Incidence of postpancreatectomy Hemorrhage | 30 days post-surgery | Per International Study Group on Pancreatic Fistula (ISGPS) criteria. |
| Mortality Rate | 90 days post-surgery | All-cause mortality. |
| Length of Hospital Stay | Up to 90 days | Total number of days in hospital following surgery(days). |
Countries
Egypt
Contacts
Primary ContactSaleh K Saleh, MD
Outcome results
None listed