NCT06204497Completed
The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in 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
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the safety and efficiency of stent-based tiverting technique (SDT) versus ileostomy in rectal cancer patients. After the removal of the rectal tumor, participants who are at high risk for anastomotic leakage will either undergo SDT or ileostomies. Researchers will compare SDT to see if SDT could help patients save hospital stays, lower medical costs, and enhance their quality of life, and not alternatively avoid defunction stoma.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 570 (actual)
- First submitted
- 12 Dec 2023
- Start date
- 31 Jan 2024
- Primary completion date
- 28 Sept 2025
- Lead sponsor
- Sir Run Run Shaw Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06204497
What you commit to
- Study type: Interventional
- Participants enrolled: 570
- From 31 Jan 2024 to the primary completion date, 28 Sept 2025
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous rectectomy, except endoscopic mucosal resection or endoscopic submucosal dissection.
Other illness
- Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active colitis ulcerosa.
- History of unstable angina, myocardial infarction, cerebrovascular accident within the past six months.
- 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.
- Patients with severe complications who do not tolerate surgery or need emergency surgery due to complication (bleeding, obstruction or perforation)
- 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).
Who the study is looking for
- Rectal adenocarcinoma confirmed pathologically.
- Rectal cancer patients with high-risk of anastomotic leakage(AL).
- Age from over 18 to under 80 years.
- Performance status of 0/1 on ECOG (Eastern Cooperative Oncology Group) scale.
- ASA (American Society of Anesthesiology) score class I, II, or III.
- Written informed consent.
- Definition of high-risk of AL (one of them):
- Preoperative body mass index (BMI) ≥30 kg/m2;
- Long-term use of glucocorticoids before surgery (≥2 weeks);
- 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;
- Preoperative neoadjuvant radiotherapy;
- Distance between tumor and anal anus (baseline MRI) ≤7cm
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospita Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking Union Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Cancer Hospital, Peking University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Xiangya Hospital, Central South Universit Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sichuan Cancer Hospital, University of Electronic Science and Technology of China Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Fujian Union Hospital, Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital, Jilin University Coordinator of this site? Confirm its status | Jilin City | China | Unknown status |
| The First Affiliated Hospital, Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| The Affiliated Hospital, Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Cancer hospital Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| ChangHai Hospital, The Second Military Medical University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital, China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The Second Affiliated Hospital, Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Union Hospital, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.