Comparing stent-based diverting technique to ileostomy for rectal cancer patients

The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients: A Prospective, Multicenter, Open-label, Non-inferiority, Randomized Controlled Study

This study is testing whether a new stent-based technique can help rectal cancer patients avoid complications and have a better recovery compared to the traditional ileostomy after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 570 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sir Run Run Shaw Hospital (Academic / other)
• Locations: 20 sites (Beijing, Beijing and 19 other locations)
• Trial ID: NCT06204497 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficiency of a stent-based diverting technique (SDT) compared to ileostomy in patients with rectal cancer who are at high risk for anastomotic leakage. Participants will undergo either SDT or ileostomy after tumor removal, and the study will assess severe complications within 90 days post-surgery. Secondary endpoints include total complications, incidence of anastomotic leakage, hospital stay duration, medical costs, and quality of life evaluations. The goal is to determine if SDT can reduce hospital stays and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with rectal adenocarcinoma and a high risk of anastomotic leakage.

Not a fit: Patients with low risk of anastomotic leakage or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to fewer complications and improved quality of life for rectal cancer patients.

How similar studies have performed: While the stent-based diverting technique is a relatively novel approach, similar studies have shown promising results in reducing complications in high-risk surgical patients.

Eligibility criteria

Inclusion Criteria:

1. Rectal adenocarcinoma confirmed pathologically.
2. Rectal cancer patients with high-risk of anastomotic leakage(AL).
3. Age from over 18 to under 80 years.
4. Performance status of 0/1 on ECOG (Eastern Cooperative Oncology Group) scale.
5. ASA (American Society of Anesthesiology) score class I, II, or III.
6. Written informed consent.

Definition of high-risk of AL (one of them):

1. Preoperative body mass index (BMI) ≥30 kg/m2;
2. Long-term use of glucocorticoids before surgery (≥2 weeks);
3. Poor general condition: Preoperative serum albumin was less than 30.0g/L after supportive treatment; or Preoperative renal replacement therapy (blood purification/hemodialysis) is required; or diabetes;
4. Preoperative neoadjuvant radiotherapy;
5. Distance between tumor and anal anus (baseline MRI) ≤7cm
6. The number of stapler used to cut the rectum during the operation ≥3; or the defect of anastomosis is observed; or Intraoperative leak test was positive.

Exclusion Criteria:

1. History of previous rectectomy, except endoscopic mucosal resection or endoscopic submucosal dissection.
2. Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active colitis ulcerosa.
3. History of unstable angina, myocardial infarction, cerebrovascular accident within the past six months.
4. Groups who are particularly vulnerable include those who suffer from mental disease, cognitive impairment, severe illness, adolescents, illiterates, women during pregnancy or breast-feeding, etc.
5. Patients with severe complications who do not tolerate surgery or need emergency surgery due to complication (bleeding, obstruction or perforation)
6. Unable ot radical resection, or underwent Miles or Hartmann or TaTME procedure, or requirement of simultaneous surgery for other disease (except the gallblader or appendix due to benign lesion).

Where this trial is running

Beijing, Beijing and 19 other locations

• Beijing Friendship Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Cancer Hospital, Peking University — Beijing, Beijing, China (Not_yet_recruiting)
• Peking Union Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Chinese PLA General Hospita — Beijing, Beijing, China (Not_yet_recruiting)
• Fujian Union Hospital, Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• The First Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Union Hospital, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Xiangya Hospital, Central South Universit — Changsha, Hunan, China (Not_yet_recruiting)
• The First Affiliated Hospital, Jilin University — Jilin, Jilin, China (Not_yet_recruiting)
• Shengjing Hospital, China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• The Affiliated Hospital, Qingdao University — Qingdao, Shandong, China (Not_yet_recruiting)
• Cancer Hospital, Fudan University — Shanghai, Shanghai, China (Not_yet_recruiting)
• ChangHai Hospital, The Second Military Medical University — Shanghai, Shanghai, China (Not_yet_recruiting)
• Sichuan Cancer Hospital, University of Electronic Science and Technology of China — Chengdu, Sichuan, China (Not_yet_recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Sir Run Run Shaw Hospital, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital, Ningbo University — Ningbo, Zhejiang, China (Not_yet_recruiting)
• The Second Affiliated Hospital, Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Principal investigator: XiuJun Cai, MD — Sir Run Run Shaw Hospital
• Study coordinator: Yifan Tong, PhD

Conditions Rectal Neoplasms; Stent-based diverting technique; Ileostomy; Complication; Anastomotic leakage