Reinforced Pancreaticojejunostomy With or Without glubran2
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: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2), Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2).
- Кому может быть актуально
- Состояния в реестре: Pancreatic Fistula, Pancreas Cancer, Periampullary Carcinoma, Pancreatic Ductal Adenocarcinoma. 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Impact of Reinforced Pancreaticojejunostomy With or Without Tissue Adhesive Glue Modified Cyanoacrylate (Glubran 2) Following Pancreaticoduodenectomy, Randomized Controlled Clinical Trial.
Обзор
Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend different techniques in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula by enforce pancreaticojejunostomy with tissue glue .
Подробное описание
Tissue adhesives have gained popularity in various fields of surgical practice. There are various types of tissue adhesives, each with their own adhesive mechanisms and uses. Basically, a tissue adhesive forms bonds with its substrate, ensuring sufficient adhesion. These bonds can either be chemical, of which covalent bonds are the strongest, or physical, including hydrogen bonds or van der Waals forces. Furthermore, the total strength of the glue bond depends on the balance between interaction within the tissue adhesive (cohesion) and between the tissue adhesive-substrate interface (adhesion). Tissue adhesives can either be glues, intended to independently connect various structures (i.e., wound edges), or sealants, used to cover and protect an anastomosis .
Except for external use, tissue adhesives can also be used intracorporeally. Various tissue adhesives are being used in cardiovascular surgery, plastic surgery, and, increasingly, surgery of the GI tract .
Tissue adhesives are promising tools for wound closure. They distribute forces throughout the wound more evenly and noninvasively than sutures and staples, are strong and flexible, and do not interfere with the wound-healing process. Also, the technique of tissue adhesive application to the wound is easy and standardizable, resulting in less variation in technique between surgeons .
By using tissue adhesives as sealants of GI anastomosis, enhancing standard anastomotic techniques. Numerous research projects have been undertaken to assess the applicability of available tissue adhesives in GI surgery; however, no recent literature provides the surgical community with an up-to-date overview of the progress in this field .
•After being informed about the study and potential risks, all patients giving written consent. Eligible patients were randomly assigned in a 1:1 ratio to either the Glubran®2 group (Group A) or the Control group (Group B) using a computer-generated randomization sequence with permuted blocks of 4 and 6. Allocation concealment was ensured using serially numbered, opaque, sealed envelopes prepared by an independent statistician. Each envelope was opened by the scrub nurse or anesthesiologist immediately after the completion of the pancreaticojejunostomy anastomosis, before final hemostasis and abdominal closure
Вмешательства
- Препарат Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)
pancreaticojejunostomy was done with application of glubran 2: The blister pack was opened, and the sterile single-dose vial was released directly onto the operating table in a sterile environment, Draw the Glubran 2 out of the single-dose vial using a sterile syringe then put the syringe into applicator Glubran 2 was applied into anastomosis by applicator in spraying manner . Whenever possible, the area to be treated should be cleaned before application. When applied in such a minimal amount, o - Процедура Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)
Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)
Первичные конечные точки
- the rate of Postoperative pancreatic fistula within 2 weeks after operation [Срок оценки: within 2 weeks after operation]
Вторичные конечные точки (12)
- Post-Pancreatectomy Hemorrhage [Срок оценки: 90 days]
- Delayed Gastric Emptying [Срок оценки: 90 days]
- Biliary fistula [Срок оценки: 90 days]
- Abdominal abscess [Срок оценки: 90 days]
- Acute pancreatitis [Срок оценки: 1 day post index surgery]
- Wound infection [Срок оценки: 90 days]
- Blood transfusions [Срок оценки: 90 days]
- Reoperation [Срок оценки: 90 days]
- Readmission [Срок оценки: 30 days after hospital discharge]
- Length of Hospital Stay [Срок оценки: 1 year]
- Mortality [Срок оценки: 90 days]
- Removal time of drain [Срок оценки: From date of surgery until the date of the last drainage removal, whichever came first, assessed up to study completion, an average of 1 year]
Критерии участия
Критерии включения
- All the patients undergoing pancreaticoduodenectomy for cancer
- Patients able to give their informed consent
Критерии исключения
- Unfit patients for surgery due to severe medical illness.
- Inoperable patients by imaging studies, irresectable tumors after laparotomy or diagnostic laparoscopy.
- Presence of distant metastasis .
- 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
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Liver and GIT hospital / Minia university — Minya
Публикации
- Saleh SK, Farahat MS, Mohamed TA, Hendy MM. Impact of reinforced pancreaticojejunostomy with or without tissue adhesive glue modified cyanoacrylate following pancreaticoduodenectomy: a randomized controlled clinical trial. World J Surg Oncol. 2026 Jun 30;24(1):268. doi: 10.1186/s12957-026-04476-3. PMID 42381068
Идентификаторы
NCT: NCT06756074 · 1350/11/2024