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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
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

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese PLA General Hospita
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BeijingChinaUnknown status
Beijing Friendship Hospital
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BeijingChinaUnknown status
Peking Union Hospital
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BeijingChinaUnknown status
Cancer Hospital, Peking University
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BeijingChinaUnknown status
Xiangya Hospital, Central South Universit
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ChangshaChinaUnknown status
Sichuan Provincial People's Hospital
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ChengduChinaUnknown status
Sichuan Cancer Hospital, University of Electronic Science and Technology of China
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ChengduChinaUnknown status
Fujian Union Hospital, Fujian Medical University
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FuzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Zhejiang University
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HangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University
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HangzhouChinaUnknown status
The First Affiliated Hospital, Jilin University
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Jilin CityChinaUnknown status
The First Affiliated Hospital, Ningbo University
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NingboChinaUnknown status
The Affiliated Hospital, Qingdao University
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QingdaoChinaUnknown status
Cancer hospital Fudan University
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ShanghaiChinaUnknown status
ChangHai Hospital, The Second Military Medical University
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ShanghaiChinaUnknown status
Shengjing Hospital, China Medical University
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ShenyangChinaUnknown status
The Second Affiliated Hospital, Wenzhou Medical University
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WenzhouChinaUnknown status
Union Hospital, Huazhong University of Science and Technology
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WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.