The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients

May 5, 2026 updated by: Xiujun Cai, Sir Run Run Shaw Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In patients with rectal cancer who have a high risk of anastomotic leakage, we aim to compare the safety and effectiveness of SDT versus ileostomy in this study. The primary endpoint of the study was severe complications that occurred within 90 days of the surgery. The secondary endpoints included total complications, the incidence of coloanal anastomotic leakage (Grade B/C), postoperative hospital stay and cost, and postoperative quality of life evaluation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
570

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Peking Union Hospital
      • Beijing, Beijing Municipality, China, 100000
        • Beijing Friendship Hospital
      • Beijing, Beijing Municipality, China, 100000
        • Cancer Hospital, Peking University
      • Beijing, Beijing Municipality, China, 310000
        • Chinese PLA General Hospita
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Fujian Union Hospital, Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital, Sun Yat-sen University
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Union Hospital, Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410000
        • Xiangya Hospital, Central South Universit
    • Jilin
      • Jilin, Jilin, China, 132000
        • The First Affiliated Hospital, Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Shengjing Hospital, China Medical University
    • Shandong
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital, Qingdao University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Cancer Hospital, FuDan University
      • Shanghai, Shanghai Municipality, China, 200000
        • ChangHai Hospital, The Second Military Medical University
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Sichuan Provincial People's Hospital
      • Chengdu, Sichuan, China, 610000
        • Sichuan Cancer Hospital, University of Electronic Science and Technology of China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310000
        • The First Affiliated Hospital, Zhejiang University
      • Hangzhou, Zhejiang, China, 310000
        • Sir Run Run Shaw Hospital, Zhejiang University
      • Ningbo, Zhejiang, China, 315000
        • The First Affiliated Hospital, Ningbo University
      • Wenzhou, Zhejiang, China, 325000
        • The Second Affiliated Hospital, Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stent-based Diverting Technique
For Stent-based Diverting Technique, the small intestine measuring 15 cm from the ileocecal junction was pulled out through the median incision in the lower abdomen. After a length-wise incision was established in the mesenteric margin of the small intestine, the degradable stent was implanted, and the intestine was sutured. Then, the stent was held in place using an external tie around the bowel. Next, a mushroom-like tube (28 Fr) was placed into the intestine proximal (5-10 cm) to the aforementioned stent. The other side of the mushroom-like tube was inserted through the right lower abdominal wall and connected with a drainage bag. An abdominal drainage tube, or an anal tube, if necessary, was inserted in the proper location prior to the closure of the incision and the abdominal cavity. Abdominal X-ray was routinely performed every week to detect stent degradation, and the mushroom-like tube (28 Fr) was removed two days after stent degradation.
Procedure: Stent-based Diverting Technique
The stent-based diverting technique (SDT) contains two parts to achieve feces diversion One is a degradable solid intestinal stent to be implanted 20 cm from the terminal ileum and could be gradually degraded within 3-4 weeks. Another part is a drainage tube to be placed at the proximal 5-10 cm of the aforementioned stent. Given this SDT, intestinal contents could be diverted through the drainage tube, and the stent prevents the feces from entering the distal intestinal. After removing the drainage tube after 3-4 weeks, intestinal contents will freely access the distal intestinal space following the degradation of the stent. For patients, stoma reversal is avoided.
Active Comparator: Ileostomy
There will be an ileostomy for the control group. An incision with a diameter of 2 cm will be performed in the lower abdomen, and layers will be separated into the abdominal cavity. The intestine, 20cm to the ileocecal juction under laparoscopic vision, will be pulled out. The anterior sheath of the rectus abdominis and the serous layer of the intestine will be sutured with an absorbable line. Then, the middle point of the mesangial margin of the intestine will be transected, and the intestine will be fixed on the skin. No volvulus or angular formation of the intestine should be confirmed laparoscopically.
Procedure: Stent-based Diverting Technique
The stent-based diverting technique (SDT) contains two parts to achieve feces diversion One is a degradable solid intestinal stent to be implanted 20 cm from the terminal ileum and could be gradually degraded within 3-4 weeks. Another part is a drainage tube to be placed at the proximal 5-10 cm of the aforementioned stent. Given this SDT, intestinal contents could be diverted through the drainage tube, and the stent prevents the feces from entering the distal intestinal. After removing the drainage tube after 3-4 weeks, intestinal contents will freely access the distal intestinal space following the degradation of the stent. For patients, stoma reversal is avoided.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of severe complications within 90-day
Time Frame: Study group, from SDT to postoperative 90 days, Control group, from ileostomy to postoperative 90 days of reversal of stoma.
Clavein-Dindo≥III
Study group, from SDT to postoperative 90 days, Control group, from ileostomy to postoperative 90 days of reversal of stoma.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total complications
Time Frame: Study group, from SDT to postoperative 90 days; Control group, from ileostomy, plus interval time before stoma reversal, to postoperative 90 days of reversal of stoma
Clavein-Dindo I to V
Study group, from SDT to postoperative 90 days; Control group, from ileostomy, plus interval time before stoma reversal, to postoperative 90 days of reversal of stoma
Clinical anastomotic leakage
Time Frame: Study group, from SDT to postoperative 90 days; Control group, from ileostomy, plus interval time before stoma reversal, to postoperative 90 days of reversal of stoma
Grade B or Grade C
Study group, from SDT to postoperative 90 days; Control group, from ileostomy, plus interval time before stoma reversal, to postoperative 90 days of reversal of stoma
Postoperative hospital stay
Time Frame: Study group, from SDT to discharge, and adding second postoperative hospital stay if the patient received the ileostomy. Control group, from ileostomy to discharge and from stoma reversal to discharge，up to six months for both group
Postoperative hospital stay after SDT or ileostomy or reversal of stoma
Study group, from SDT to discharge, and adding second postoperative hospital stay if the patient received the ileostomy. Control group, from ileostomy to discharge and from stoma reversal to discharge，up to six months for both group
Total medical Costs
Time Frame: From first admission to end of follow-up or date of death from any cause, whichever came first, assessed up to six months for both group
Including medical costs, surgery costs and other costs
From first admission to end of follow-up or date of death from any cause, whichever came first, assessed up to six months for both group
Quality of life evaluation
Time Frame: Study group, 90 days after SDT; Control group, 90 days after ileostomy
SF-8 scale
Study group, 90 days after SDT; Control group, 90 days after ileostomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sir Run Run Shaw Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: XiuJun Cai, MD, Sir Run Run Shaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SRRSH.SDT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data are available from the Principal Investigator upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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