External Pancreatic Stent in Pancreaticojejunostomy

Официальное название

The Impact of External Pancreatic Drainage During Pancreaticojejunostomy Following Pancreaticoduodenectomy in Cases of Soft Pancreas

Обзор

Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.

Подробное описание

The role of external pancreatic duct drainage in managing patients with a soft pancreas is particularly important, as these patients are at a heightened risk of developing postoperative complications. By providing an external route for pancreatic secretions, external pancreatic duct drainage may help to reduce the enzymatic activity at the anastomosis site and promote better healing.

In addition to reducing the incidence of post operative pancreatic fistula, external pancreatic duct drainage may have other potential benefits, such as decreasing the length of hospital stay, reducing the need for additional interventions, and improving overall patient quality of life. However, these potential benefits must be weighed against the risks and drawbacks of external pancreatic duct drainage, including the potential for stent-related complications and the need for an additional procedure to remove the stent.

•After being informed about the study and potential risks, all patients giving written consent. Patients who meet the eligibility requirements will be randomized in a 1:1 ratio to external pancreatic drainage group and no external pancreatic drainage group.

Вмешательства

• Процедура Pancreaticojejunostomy with external stent
  Inserting ureteric stent at the pancreaticojejunostomy site
• Процедура Pancreaticojejunostomy without external stent
  Only Pancreaticojejunostomy without inserting external stent

Первичные конечные точки

• evidence of pancreatic fistula [Срок оценки: within the first 7 days after surgery( first day, third day and fifth day)]

Вторичные конечные точки (1)

• evidence of intra abdominal collection [Срок оценки: first week, second week postoperative]

Критерии участия

Критерии включения

• Patients undergoing pancreaticoduodenectomy (Whipple procedure) for various indications (e.g., pancreatic cancer, ampullary cancer, etc.).
• Patients with a confirmed soft pancreas texture, as determined intraoperatively by the surgeon.

Критерии исключения

• Patients with a hard or fibrotic pancreas, as determined intraoperatively by the surgeon.
• Patients with severe uncontrolled comorbidities (e.g., uncontrolled diabetes, severe cardiovascular disease, renal failure).
• Pregnancy or lactation.

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

Простое слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Liver and GIT hospital , Minia University — Minya

Идентификаторы

NCT: NCT06743516 · 1282/10/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗