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Идёт набор NCT07744087

Modified Single-Incision Plus One-Port Versus Conventional Five-Port Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

Без фазы С лечением Ampullary Carcinoma Duodenal Adenocarcinoma Distal Cholangiocarcinoma

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: Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy, Conventional Laparoscopic Pancreaticoduodenectomy.
Кому может быть актуально
Состояния в реестре: Ampullary Carcinoma, Duodenal Adenocarcinoma, Distal Cholangiocarcinoma. 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
Китай
Следующий шаг
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Официальное название

Modified "Single-Incision Plus One "Versus Conventional "Five-Port" Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas: Study Protocol for A Multicentre Randomised Controlled Trial

Обзор

This multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic periampullary carcinoma who are candidates for pancreaticoduodenectomy. A total of 232 participants will be randomly assigned in a 1:1 ratio. Outcome assessors who adjudicate complications and interpret imaging will be masked to treatment assignment. The primary outcomes are all-cause mortality within 90 days after surgery and overall survival at 1 year after surgery. Secondary outcomes will assess postoperative complications, surgical performance, postoperative recovery, disease-free survival, quality of life, and health-care costs.

Вмешательства

  • Процедура Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy
    A pancreaticoduodenectomy performed through a 60- to 80-mm periumbilical single-incision access platform containing three trocars, with one additional 12-mm laparoscopic port. Resection and reconstruction are performed according to the standardized multicenter operative protocol.
  • Процедура Conventional Laparoscopic Pancreaticoduodenectomy
    A conventional laparoscopic pancreaticoduodenectomy performed using five trocar ports, followed by resection and reconstruction according to the standardized multicenter operative protocol.

Первичные конечные точки

  • Overall Survival Rate at 1 Year After Surgery [Срок оценки: From the date of surgery to 1 year after surgery]
  • All-Cause Mortality Within 90 Days After Surgery [Срок оценки: From surgery through 90 days after surgery]
Вторичные конечные точки (6)
  • Overall Postoperative Complication Rate Within 30 Days [Срок оценки: From surgery through 30 days after surgery]
  • R0 Resection Rate [Срок оценки: At final postoperative pathological assessment, up to 30 days after surgery]
  • Operative Time [Срок оценки: During the index surgery]
  • Disease-Free Survival Rate at 1 Year After Surgery [Срок оценки: From the date of surgery to 1 year after surgery]
  • Conversion to Open Surgery Rate [Срок оценки: During the index surgery]
  • Postoperative Length of Hospital Stay [Срок оценки: From surgery to hospital discharge, up to 30 days after surgery]

Критерии участия

Критерии включения

  • Age 18 years or older and younger than 75 years.
  • Histopathologically confirmed non-pancreatic periampullary carcinoma, or a high clinical suspicion of non-pancreatic periampullary carcinoma when preoperative pathological confirmation is unavailable.
  • Determined by preoperative multidisciplinary team evaluation to require pancreaticoduodenectomy.
  • Able to understand and comply with study procedures.
  • Able and willing to provide written informed consent before any study-specific screening procedure.
  • Expected to benefit from therapeutic pancreaticoduodenectomy according to applicable clinical guidelines.

Критерии исключения

  • Distant metastasis, including peritoneal, hepatic, distant lymph node, or other organ metastasis.
  • Requirement for distal, central, or total pancreatectomy, or another palliative procedure.
  • Preoperative American Society of Anesthesiologists physical status classification of 4 or higher.
  • Concurrent malignancy other than the target cancer.
  • Pregnancy or breastfeeding.
  • Severe psychiatric disorder that would interfere with study participation.
  • Receipt of neoadjuvant chemotherapy or radiotherapy before surgery.
  • Vascular invasion requiring vascular resection, as determined by the multidisciplinary team based on preoperative abdominal imaging.
  • Body mass index greater than 35 kg/m².
  • Participation in another clinical trial within the previous 3 months.

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
Лечение

Центры проведения

Китай · 4 центра
  • The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) — Чунцин
  • Nanfang Hospital, Southern Medical University — Гуанчжоу
  • West China Hospital, Sichuan University — Чэнду
  • The People's Hospital of Jianyang City — Jiancheng

Идентификаторы

NCT: NCT07744087 · NFEC-2026-403

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗