Saleh's Technique for Pancreaticojejunostomy (Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®).
- Кому может быть актуально
- Состояния в реестре: Pancreaticoduodenectomy, Postoperative Pancreatic Fistula, Pancreas Cancer, Periampullary Cancer. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Pancreatic Parenchymal Injection of N-Butyl-2-Cyanoacrylate for Pancreaticojejunostomy After Pancreaticoduodenectomy: A Novel Technique
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат 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 du
Первичные конечные точки
- Incidence of postoperative pancreatic fistula [Срок оценки: 10 days]
Вторичные конечные точки (5)
- Incidence of postoperative acute pancreatitis [Срок оценки: 1 day post index surgery]
- Incidence of Post-Pancreatectomy Hemorrhage [Срок оценки: 90 days]
- Incidence of intra-abdominal abscess [Срок оценки: 90 days]
- Incidence of biliary fistula [Срок оценки: 90 days]
- Rate of readmission [Срок оценки: 30 days after hospital discharge]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Liver and GIT hospital , Minia University — Minya
Публикации
- 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; Int PMID 28040257
- 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. PMID 23122535
- 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. PMID 12430080
- 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. PMID 18362839
Идентификаторы
NCT: NCT07132541 · 1606/07/2025