Pancreas Cancer, Pancreaticoduodenectomy, Periampullary Cancer, Postoperative Pancreatic Fistula
Conditions
Keywords
Pancreatic surgery, Anastomotic leak, Tissue adhesive, Postoperative Pancreatic Fistula (POPF), Pancreaticoduodenectomy (PD), Pancreaticojejunostomy (PJ)
Brief summary
This randomized controlled trial investigates the safety and efficacy of injecting N-butyl-2- cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the pancreaticojejunostomy (PJ) anastomosis and reduce postoperative pancreatic fistula (POPF) rates.
Detailed description
This randomized controlled trial aims to evaluate the efficacy of pancreatic parenchymal N-Butyl-2-Cyanoacrylate (NBCA) injection in reducing the incidence and severity of postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy (PD). POPF remains a major complication of PD, leading to increased morbidity, mortality, and healthcare costs. NBCA, a tissue adhesive, has shown promise in various surgical applications due to its hemostatic and sealing properties. This study will enroll approximately 90 patients undergoing PD, randomly assigning them to either the NBCA injection group or the control group. The primary outcome will be the incidence of POPF according to the International Study Group on Pancreatic Surgery (ISGPS) definition. Secondary outcomes includes length of hospital stay, readmission rates, reoperation rates, mortality, and other postoperative complications. This trial is designed to provide high level evidence regarding the utility of NBCA in improving outcomes after PD.
Interventions
DRUGPancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group.
This procedure is integrated into the standard pancreaticoduodenectomy. Injection of Histoacryl® (n-butyl-2-cyanoacrylate) mixed with Lipiodol® (1:1 ratio) into the pancreatic parenchyma circumferentially (3, 6, 9, and 12 o'clock positions) around the main pancreatic duct (MPD) orifice, extending 5-8 mm deep and 5-10 mm laterally from the future anastomotic line, avoiding the main pancreatic duct and vessels. Total volume injected typically ranges from 0.2 ml to 0.6 ml. Follow with standard duct-to-mucosa pancreaticojejunostomy: * Tying down the posterior duct-to-mucosa sutures. * Placing and tying the anterior duct-to-mucosa sutures. * Tying down the posterior outer layer sutures. * Placing the anterior outer layer sutures. Meticulously avoid glue contact with sutures/mucosa Reconstruction: Complete the hepaticojejunostomy and duodenojejunostomy (or gastrojejunostomy).
PROCEDUREStandard Pancreaticojejunostomy
Patients randomized to this group will undergo pancreaticoduodenectomy and pancreaticojejunostomy using the standard surgical technique of the institution, without the application of N-Butyl-2-Cyanoacrylate or any other sealant to the pancreatic anastomosis. No placebo injection will be administered.
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Patients randomized to the groups will receive a standardized volume (e.g., 0.5 mL of a 1:1 mixture of NBCA and Lipiodol) of N-Butyl-2-Cyanoacrylate injected into the pancreatic parenchyma during pancreaticojejunostomy. The injection will be performed using a fine-gauge needle at multiple points to ensure even distribution. The specific NBCA product will be a commercially available, cyanoacrylate adhesive (e.g., Histoacryl®).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing pancreaticoduodenectomy for malignant lesions meeting the curative treatment intent in accordance with clinical guidelines. * Soft pancreatic texture. * Small main pancreatic duct diameter (\<3 mm). * Informed consent obtained.
Exclusion criteria
* Known hypersensitivity to cyanoacrylate or Lipiodol®. * Extremely hard, fibrotic pancreas. * Significant pancreatitis involving the pancreatic remnant. * Active infection at the surgical site. * Uncontrolled coagulopathy. * Unfit patients for surgery due to severe medical illness. * Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs. * Irresectable tumors in diagnostic laparoscopy. * Patients requiring left, central or total pancreatectomy or other palliative surgery. * Pregnant or breastfeeding women. * Patients with serious mental disorders. * Patients with vascular invasion and requiring vascular resection. * Patients refused to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative pancreatic fistula | Up to 90 days post-surgery | A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative acute pancreatitis | 1 day post index surgery | Altered serum amylase count on postoperative day 0 or 1 |
| Incidence of Post-Pancreatectomy Hemorrhage | 90 days | As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates |
| Incidence of intra-abdominal abscess | 90 days | Collection containing gas bubbles, determining systemic signs of infection |
| Incidence of biliary fistula | 90 days | Output of bile from drains on or by post operative day 3 |
| Rate of readmission | 30 days after hospital discharge | New admission within 30 days of discharge from hospital |
Countries
Egypt
Contacts
Primary ContactSaleh K Saleh, MD
Outcome results
None listed