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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-butyl-2-cyanoacrylate (Histoacryl® )Injection Group. | Experimental | Patients in this group will receive pancreatic parenchymal injection of N-butyl-2-cyanoacrylate during pancreaticoduodenectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®) | Drug | 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:
Reconstruction: Complete the hepaticojejunostomy and duodenojejunostomy (or gastrojejunostomy). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative pancreatic fistula | 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. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative acute pancreatitis | Altered serum amylase count on postoperative day 0 or 1 | 1 day post index surgery |
| Incidence of Post-Pancreatectomy Hemorrhage | As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saleh K Saleh, MD | Contact | 01201765401 | +2 | salehkhairy@mu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Saleh K Saleh, MD | Minia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver and GIT hospital , Minia University | Recruiting | Minya | Minya Governorate | 61519 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28040257 | Background | Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28. | |
| 23122535 |
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Patients receiving pancreatic parenchymal injection of N-butyl-2-cyanoacrylate (Histoacryl®) during pancreaticojejunostomy
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|
|
| 90 days |
| Incidence of intra-abdominal abscess | Collection containing gas bubbles, determining systemic signs of infection | 90 days |
| Incidence of biliary fistula | Output of bile from drains on or by post operative day 3 | 90 days |
| Rate of readmission | New admission within 30 days of discharge from hospital | 30 days after hospital discharge |
| Background |
| Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2. |
| 12430080 | Background | Seewald S, Sriram PV, Naga M, Fennerty MB, Boyer J, Oberti F, Soehendra N. Cyanoacrylate glue in gastric variceal bleeding. Endoscopy. 2002 Nov;34(11):926-32. doi: 10.1055/s-2002-35312. No abstract available. |
| 18362839 | Background | Lamsa T, Jin HT, Sand J, Nordback I. Tissue adhesives and the pancreas: biocompatibility and adhesive properties of 6 preparations. Pancreas. 2008 Apr;36(3):261-6. doi: 10.1097/MPA.0b013e31816714a2. |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004659 | Enbucrilate |
| D014014 | Tissue Adhesives |
| ID | Term |
|---|---|
| D003487 | Cyanoacrylates |
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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