LIRRH Trial for the Right-sided Colon Cancer

Официальное название

Laparoscopic Ileocecal Reconstruction Right Hemicolectomy (LIRRH) Trial for the Right-sided Colon Cancer

Обзор

The aim of this clinical trial is to compare the short- and long-term outcomes of laparoscopic ileocecal reconstruction right hemicolectomy (LIRRH) with those of traditional laparoscopic right hemicolectomy (TRH) for ascending and proximal transverse colon cancer.

Подробное описание

This is a prospective, single-center, open-label, randomized controlled clinical trial. Eligible patients will be randomly assigned (1:1) to undergo either LIRRH or TRH and will receive the corresponding surgical procedure.

Primary endpoint: 3-year disease-free survival (DFS).

Secondary endpoints:

1. Complications within 90 days postoperatively; 2. Pathology-related indicators, including positive margin rate, number of harvested lymph nodes, and lymph-node metastasis rate; 3. Assessment of postoperative intestinal microbiota changes; 4. 5-year overall survival (OS).

Вмешательства

• Процедура Laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH)
  The ileocolic vessels are divided at their roots, and lymph nodes of stations 203, 202, and 201 are dissected. The right colic and middle colic vessels are also divided at their roots, and the surrounding lymphatic and adipose tissue (stations 211/212/213 and 221/222/223) is cleared. The transverse colon is transected 10 cm distal to the tumor, and the ileum is divided 10 cm proximal to the ileocecal region. After tailoring the ileal mesentery, an end-to-end ileo-transverse colonic anastomosis i
• Процедура traditional laparoscopic right hemicolectomy (TRH)
  The ileocolic vessels are divided at their roots, and lymph nodes of stations 203, 202, and 201 are dissected. The right colic and middle colic vessels are likewise divided at their roots, and the surrounding lymphatic and adipose tissue (stations 211/212/213 and 221/222/223) is cleared. The transverse colon is transected 10 cm distal to the tumor, and the ileum is divided 10 cm proximal to the ileocecal junction. An end-to-side or side-to-side ileo-transverse colonic anastomosis is then perform

Первичные конечные точки

• 3-year disease-free survival (DFS) [Срок оценки: From date of randomization until the date of first documented recurrence or death from any cause, assessed up to 36 months]

Вторичные конечные точки (5)

• 10-day postoperative diarrhea rate [Срок оценки: Within 10 days after surgery]
• 15-day postoperative ileus rate [Срок оценки: 15 days after surgery]
• Pathology-related composite indicator [Срок оценки: Immediate (on specimen examination, within 7 days post-op)]
• Postoperative gut microbiota diversity [Срок оценки: 6 months and 1 year post-surgery]
• 5-year overall survival [Срок оценки: From randomization to death from any cause, assessed up to 60 months]

Критерии участия

Критерии включения

• Age 18-75 years
• ASA physical status ≤ III
• Endoscopy and biopsy-proven colon adenocarcinoma
• Contrast-enhanced abdominal CT showing primary tumor located in the ascending colon or proximal transverse colon (proximal one-third)
• Pre-operative clinical stage: TanyNanyM0
• Able to understand the study protocol, willing to participate, and provide written informed consent

Критерии исключения

• History of hypertensive crisis or hypertensive encephalopathy.
• Severe cardiopulmonary insufficiency or any other contraindication to surgery.
• Uncorrectable electrolyte disturbances (e.g., potassium, calcium, magnesium).
• Evidence of significant bleeding diathesis or high hemorrhagic risk:
• Prior intracranial or intraspinal hemorrhage.
• Tumor invading major vessels with obvious bleeding risk.
• Thrombotic or embolic event within 6 months before study treatment, or significant vascular disease (e.g., surgical-repair aortic aneurysm).
• Clinically relevant hemoptysis or tumor bleeding of any cause within 1 month before screening.
• Therapeutic-dose anticoagulation within 2 weeks before study treatment (except low-molecular-weight heparin).
• Antiplatelet therapy within 10 days before study treatment (e.g., aspirin > 325 mg/day, clopidogrel > 75 mg/day, dipyridamole, ticlopidine, cilostazol).
• Active tuberculosis.
• Any active autoimmune disease or history of autoimmune disease with expected recurrence (including but not limited to SLE, RA, autoimmune hepatitis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyper- or hypothyroidism, asthma requiring bronchodilators).
• Pre-operative evidence of synchronous multiple primary colorectal cancers or other conditions requiring additional bowel resection.
• Pre-operative imaging or intra-operative findings showing:
• Tumor infiltration into adjacent organs requiring multi-visceral resection;
• Distant metastasis;
• Unresectable (unable to achieve R0) disease.
• Other malignancies within the past 5 years, or familial adenomatous polyposis; except cured carcinoma in situ of the cervix, basal-cell carcinoma, papillary thyroid carcinoma, or cutaneous squamous-cell carcinoma.
• Intestinal obstruction, perforation, or bleeding requiring emergency surgery.
• Patient unsuitable or unable to tolerate laparoscopic surgery.
• Pregnant or lactating women.
• History of psychiatric disorders precluding compliance.
• Prior neoadjuvant therapy.
• Multidisciplinary team (MDT) decision that the patient is not appropriate for the study.
• Patient unable to understand the study conditions/objectives and refuses to give 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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Fourth Hospital of Hebei Medical University — Shijiazhuang

Идентификаторы

NCT: NCT07207317 · 2025KS060 · 2025KS060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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