Inverted-Ω Anastomosis in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy

Официальное название

Modified Digestive Tract Reconstruction in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy: Inverted-Ω Anastomosis

Обзор

The goal of this clinical trial is to learn if inverted-Ω anastomosis after pancreatic head resection or mid-pancreatectomy works in benign or low-grade malignant tumor. It will also learn about the safety and feasibility of inverted-Ω anastomosis. The main questions it aims to answer are: 1. Does inverted-Ω anastomosis operate safely? (operative time, blood loss, transfusion and conversion rate) 2. What is the incidence and severity of postoperative complications in inverted -Ω anastomosis? What advantages does it have over conventional anastomosis methods such as roux-en-y？

Вмешательства

• Процедура Inverted-Ω Anastomosis
  After meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tract

Первичные конечные точки

• Safety and assessment of the surgical process [Срок оценки: During operation]
• Operative time [Срок оценки: During operation]
• Intraoperative blood loss [Срок оценки: During operation]
• Postoperative complications [Срок оценки: From the date of surgery (Day 0) up to 90 days postoperatively]

Вторичные конечные точки (1)

• Short-term survival [Срок оценки: From the date of surgery (Day 0) up to 3 years postoperatively]

Критерии участия

Критерии включения

• Age 18 to 75 years old, gender not limited;
• Patients diagnosed with benign or low-grade malignant tumors in the head or middle section of the pancreas by CT or MRI;
• ECOG score 0-1.

Критерии исключения

• Those with severe heart, liver or kidney insufficiency, or those who are assessed as intolerant to surgery or anesthesia, or those with ASA grade > 3;
• Patients with a history of or concurrent other malignant tumors, or other serious infections or infectious diseases, or those who are unable to complete the anastomosis surgery;
• Uncontrollable concomitant diseases, including but not limited to severe coronary artery disease, COPD or asthma, uncontrollable cerebrovascular diseases, symptomatic congestive failure, unstable angina pectoris, arrhythmia, or other diseases that the researchers consider ineligible for enrollment;
• Patients who have undergone other upper abdominal surgeries and digestive tract reconstruction procedures in the past;
• Patients requiring combined organ resection;
• Preoperative assessment suggested that the patient might have factors such as active ulcers and bleeding in the digestive tract;
• Pregnant and lactating women;
• Any uncertain factors that have an impact on the patient's safety or compliance.

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

Китай · 1 центр

• West China Hospital — Чэнду

Идентификаторы

NCT: NCT07087392 · 2025-550

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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