PancreaticoduodenectomyPostoperative Pancreatic FistulaPancreas CancerPeriampullary Cancer
Investigational drug(s) / intervention(s)
Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®)
Pancreatic 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).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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