Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)

Официальное название

Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer - An International, Multi-centre, Single Blinded, Randomized Controlled Superiority Trial

Обзор

The Robocop trial is an international multi-centre, single blinded, randomized controlled superiority trial conducted in centres experienced in robotic-assisted liver surgery. Eligible patients for radical cholecystectomy will be randomized in a 1:1 ratio to undergo robotic-assisted or open resection within an enhanced recovery setting. The primary endpoint is time to functional recovery. Secondary endpoints include length of hospital stay, resection margin, number of retrieved lymph nodes, postoperative complications, quality of life, abdominal wall complaints and direct and indirect costs.

Подробное описание

Robotic-assisted surgery is hypothesised to reduce time to functional recovery by 2 days compared with open surgery. With a power of 80% and alpha of 0.05, the sample size needed in each arm to test superiority is 35 patients. With an expected 25% drop-out rate, 47 patients will be randomized in each group, with a total of 94 patients to be randomized in the trial.

Вмешательства

• Процедура Robotic-assisted radical cholecystectomy
  Procedure will be performed robotic-assisted
• Процедура Open radical cholecystectomy
  Procedure will be open

Первичные конечные точки

• Time to functional recovery [Срок оценки: Days from operation]

Вторичные конечные точки (6)

• Number of retrieved lymph nodes [Срок оценки: Within 6 weeks after surgery]
• Length of hospital stay [Срок оценки: Days]
• Post-operative complications [Срок оценки: Within 90 days from surgery]
• Quality of life of patients [Срок оценки: 1 year]
• Total cost [Срок оценки: 1 year]
• Abdominal wall complaints [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Patient with radiologically suspected or confirmed (≥T1b) incidental gallbladder cancer after cholecystectomy with an indication of radical cholecystectomy, without the need for resection of extrahepatic bile ducts, as decided at a multidisciplinary team conference.
• Patient sufficiently fit to undergo radical cholecystectomy according to surgeon and anaesthesiologist.

Критерии исключения

• Previous extensive surgery in the upper abdomen (for example open liver surgery)
• Pregnancy
• Intraoperative findings of dissemination (patient is then excluded after randomization)
• Intraoperative findings of the need to perform resection of extrahepatic bile ducts (patient is then excluded after randomization).
• Intraoperative findings leading to a simple cholecystectomy only (patient is then excluded after randomization)

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

Швеция · 1 центр

• Region Stockholm — Stockholm

Публикации

• Wallgren H, Gilg S, Ansorge C, Sparrelid E, Sturesson C. Initial experience with robotic-assisted resection for suspected or confirmed gallbladder cancer - comparison with open technique in a single centre retrospective observational cohort study. Scand J Gastroenterol. 2025 Jul 7:1-6. doi: 10.1080/00365521.2025.2525902. Online ahead of print. PMID 40621784

Идентификаторы

NCT: NCT06246448 · CS001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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