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New stent technique may replace ileostomy for rectal cancer patients

NCT ID NCT06204497

Symptom relief Sponsor: Sir Run Run Shaw Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a temporary stent placed inside the bowel could replace a traditional ileostomy (a bag outside the body) after rectal cancer surgery. 570 patients at high risk for leaks were randomly assigned to either the stent or ileostomy. The goal was to see if the stent could reduce hospital stays, lower costs, and improve quality of life without increasing serious complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

570 people

The number who actually took part.

Started

Jan 2024

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal neoplasms

Contacts and locations

Locations

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality, 100000, China

  • Cancer Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200000, China

  • Cancer Hospital, Peking University

    Beijing, Beijing Municipality, 100000, China

  • ChangHai Hospital, The Second Military Medical University

    Shanghai, Shanghai Municipality, 200000, China

  • Chinese PLA General Hospita

    Beijing, Beijing Municipality, 310000, China

  • Fujian Union Hospital, Fujian Medical University

    Fuzhou, Fujian, 350000, China

  • Peking Union Hospital

    Beijing, Beijing Municipality, 100000, China

  • Shengjing Hospital, China Medical University

    Shenyang, Liaoning, 110000, China

  • Sichuan Cancer Hospital, University of Electronic Science and Technology of China

    Chengdu, Sichuan, 610000, China

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610000, China

  • Sir Run Run Shaw Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310000, China

  • The Affiliated Hospital, Qingdao University

    Qingdao, Shandong, 266000, China

  • The First Affiliated Hospital, Jilin University

    Jilin City, Jilin, 132000, China

  • The First Affiliated Hospital, Ningbo University

    Ningbo, Zhejiang, 315000, China

  • The First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510000, China

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310000, China

  • The Second Affiliated Hospital, Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • Union Hospital, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000, China

  • Xiangya Hospital, Central South Universit

    Changsha, Hunan, 410000, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.