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 study 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
Postoperative pancreatic fistula (POPF) remains one of the most significant complications following pancreaticoduodenectomy (PD), with rates ranging from 10% to 30% depending on pancreatic texture and duct size. This study aims to evaluate the use of Histoacryl®, a tissue adhesive, injected into the pancreatic parenchyma to seal leaks and reinforce the anastomotic suture line, particularly in soft pancreases. The study will assess the safety, feasibility, and impact on clinically relevant POPF rates while maintaining exocrine drainage and minimizing parenchymal leakage. Thirty consecutive patients undergoing PD for pancreatic cancer, periampullary cancer, cholangiocarcinoma, or duodenal cancer will be enrolled between July 2025 and July 2026. Preoperative, intraoperative, and postoperative data will be collected and analyzed.
Interventions
DRUGPancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®)
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).
Sponsors
Minia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients receiving pancreatic parenchymal injection of N-butyl-2-cyanoacrylate (Histoacryl®) during pancreaticojejunostomy
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 | 10 days | 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
CONTACTSaleh K Saleh, MD
PRINCIPAL_INVESTIGATORSaleh K Saleh, MD
Minia University
Outcome results
None listed