LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

Официальное название

Laparoscopic Ileocecal-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon -- A Prospective, Multicenter Randomized Control Clinical Trial

Обзор

The goal of this clinical trial is to compare the long-term outcomes of Laparoscopic Ileocecal-Sparing Right Hemicolectomy(LISH) compared to traditional laparoscopic right hemicolectomy(TRH) in the treatment of hepatic flexure colon cancer and proximal transverse colon cancer.

Подробное описание

This study is a prospective, multicenter, open-labeled, randomized controlled clinical trial. The enrolled patients will be randomly assigned to either the LISH or TRH group in a 1:1 ratio and will receive the corresponding surgery. The primary endpoint: 3-year disease free survival. The second endpoint: 30-day perioperative complications, pathological outcomes (specimen quality, positive resection margin rate, number of lymph nodes retrieved, and lymph node positivity rate), histological prognostic indicators (planned for superiority testing: 1-, 3-, and 5-year rates of newly detected polyps and adenomas on colonoscopy), quality of life (planned for superiority testing: Gastrointestinal Symptom Rating Scale \[GSRS\] score and EQ-5D-5L score), and 5-year overall survival (OS).

Вмешательства

• Процедура LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）
  Preserve the ileocolic blood vessels, and perform dissection of lymph node groups 203, 202, and 201d along the root of ICV(Ileocolic artery)/ICA(Ileocolic vein). Group 201d lymph nodes are defined as the distal lymph nodes of the ileocolic vessels (colonic branch). Use an intracavitary cutting and sealing device to transect the proximal colon along the predetermined margin, and transect the transverse colon at 10cm distal to the tumor. Perform ileocecal-transverse colonic anastomosis.
• Процедура TRH（Traditional Laparoscopic Right Hemicolectomy）
  Transect the root of the ileocolic vessels and perform dissection of lymph node groups 203, 202, and 201; sever the roots of the right colic and middle colic vessels, and clear the surrounding lymphoadipose tissue (lymph node groups 211/212/213 and 221/222/223). Transect the transverse colon 10cm distal to the tumor and cut the terminal ileum 10cm from the ileocecal junction. Perform ileum-to-transverse colon anastomosis.

Первичные конечные точки

• 3-year disease free survival [Срок оценки: 3 years]

Вторичные конечные точки (6)

• Perioperative complications [Срок оценки: up to 30 days after surgery]
• Quality of the specimen [Срок оценки: up to 2 weeks after surgery]
• Incidence rates of polyps and adenomas [Срок оценки: 5 years]
• Scores of quality of life [Срок оценки: 3 years]
• Scores from the EQ-5D-5L Quality of Life Scale [Срок оценки: 3 years]
• 5-year overall survival rate (OS) [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age between 18-75 years old
• ASA classification ≤III
• Colon adenocarcinoma confirmed by endoscopy and pathological biopsy
• Enhanced abdominal CT indicating the primary lesion is located in the hepatic flexure of the colon or proximal transverse colon (proximal 1/3 of the transverse colon)
• Preoperative clinical staging: TanyNanyM0
• Patients able to understand the study protocol, willing to participate in the research, and providing written informed consent

Критерии исключения

• Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring bowel segment resection
• Preoperative imaging or intraoperative exploration reveals: 1) tumor involving surrounding organs requiring combined organ resection; 2) presence of distant metastasis; 3) inability to perform R0 resection; 4) fused and fixed lymph nodes at the root of the ileocolic vessels
• Additional radical surgery following Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) procedures
• History of any other malignant tumor within the last 5 years or familial adenomatous polyposis, except for cured in situ cervical cancer, basal cell carcinoma, papillary thyroid carcinoma, or skin squamous cell carcinoma
• Presence of bowel obstruction, bowel perforation, or intestinal bleeding requiring emergency surgery
• Patients unsuitable for or unable to tolerate laparoscopic surgery
• Pregnant or lactating women
• Patients with a history of psychiatric disorders
• Patients who have received neoadjuvant therapy prior to surgery
• Patients deemed unsuitable for the study by MDT discussion
• Patients unable to understand the study's conditions and objectives, and refusing to sign informed consent.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 29 центров

• the First Affiliated Hospital of Bengbu Medical Collage — Bengbu
• Beijing Cancer Hospital — Пекин
• Peking Union Medical College Hospital — Пекин
• Cancer Hospital Academy of medicine Scenice — Пекин
• the First Affiliated Hospital of Chongqing Medical Collage — Чунцин
• Fujian Cancer Hospital — Фучжоу
• Fujian Hospital Medical Union University — Фучжоу
• The First Affiliated Hospital of Xiamen University — Xiamen
• … и ещё 21 центр

Идентификаторы

NCT: NCT05923255 · CRCCZ-S03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗