NCT07207317招募中不适用
Laparoscopic Ileocecal Reconstruction Right Hemicolectomy (LIRRH) Trial for the Right-sided Colon Cancer
Chaoxi Zhou1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年5月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival (DFS)
研究概览
简要总结
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.
详细描述
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:
- Complications within 90 days postoperatively;
- Pathology-related indicators, including positive margin rate, number of harvested lymph nodes, and lymph-node metastasis rate;
- Assessment of postoperative intestinal microbiota changes;
- 5-year overall survival (OS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
3-year disease-free survival (DFS)
时间窗: From date of randomization until the date of first documented recurrence or death from any cause, assessed up to 36 months
DFS is defined as the time from randomization to the earliest date of locoregional recurrence, distant metastasis, second primary colorectal cancer, or death from any cause, whichever occurs first.
次要结局
- 10-day postoperative diarrhea rate(Within 10 days after surgery)
- 15-day postoperative ileus rate(15 days after surgery)
- Pathology-related composite indicator(Immediate (on specimen examination, within 7 days post-op))
- Postoperative gut microbiota diversity(6 months and 1 year post-surgery)
- 5-year overall survival(From randomization to death from any cause, assessed up to 60 months)
研究者
Chaoxi Zhou
Associate Chief Physician, Department of General Surgery
Hebei Medical University Fourth Hospital
研究点 (1)
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