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

January 10, 2024 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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

570

Phase

  • 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 Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Not yet recruiting
        • Beijing Friendship Hospital
        • Principal Investigator:
          • Zhongtao Zhang, MD
        • Sub-Investigator:
          • Hongwei Yao, MD
        • Contact:
        • Contact:
          • Hongwei Yao, MD
          • Phone Number: +86-571-13611015609
      • Beijing, Beijing, China, 100000
        • Not yet recruiting
        • Cancer Hospital, Peking University
        • Contact:
          • Aiwen Wu, MD
          • Phone Number: +86-571-13911577190
          • Email: wuaw@sina.com
        • Principal Investigator:
          • Aiwen Wu, MD
      • Beijing, Beijing, China, 100000
        • Not yet recruiting
        • Peking Union hospital
        • Principal Investigator:
          • Yi Xiao, MD
        • Contact:
      • Beijing, Beijing, China, 310000
        • Not yet recruiting
        • Chinese PLA General Hospita
        • Contact:
        • Principal Investigator:
          • Xiaohui Xiaohui, MD
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian Union Hospital, Fujian Medical University
        • Contact:
        • Principal Investigator:
          • Pan Chi, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Principal Investigator:
          • Wu Song, MD
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Union Hospital, Huazhong University of Science and Technology
        • Principal Investigator:
          • Kaixiong Tao, MD
        • Contact:
        • Contact:
          • Peng Zhang, MD
          • Phone Number: +86-571-18186100993
        • Sub-Investigator:
          • Peng Zhang, MD
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Xiangya Hospital, Central South Universit
        • Contact:
        • Principal Investigator:
          • Zhikang Chen, MD
    • Jilin
      • Jilin, Jilin, China, 132000
        • Not yet recruiting
        • The First Affiliated Hospital, Jilin University
        • Contact:
        • Principal Investigator:
          • Quan Wang, MD
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • Shengjing Hospital, China Medical University
        • Contact:
        • Principal Investigator:
          • Dingsheng Liu, MD
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Not yet recruiting
        • The Affiliated Hospital, Qingdao University
        • Contact:
        • Principal Investigator:
          • Yun Lu, MD
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • Cancer Hospital, FuDan University
        • Contact:
        • Principal Investigator:
          • Xinxiang Li, MD
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • ChangHai Hospital, The Second Military Medical University
        • Principal Investigator:
          • Wei Zhang, MD
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Minghui Pang, MD
        • Contact:
      • Chengdu, Sichuan, China, 610000
        • Not yet recruiting
        • Sichuan Cancer Hospital, University of Electronic Science and Technology of China
        • Contact:
        • Principal Investigator:
          • Hai Hu, MD
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Weiping Chen, MD
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University
        • Contact:
        • Principal Investigator:
          • Xiujun Cai, MD
        • Sub-Investigator:
          • Zhangfa Song, MD
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Contact:
        • Principal Investigator:
          • Wenbin Chen, MD
      • Ningbo, Zhejiang, China, 315000
        • Not yet recruiting
        • The First Affiliated Hospital, Ningbo University
        • Contact:
        • Principal Investigator:
          • Zhilong Yan, MD
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The Second Affiliated Hospital, Wenzhou Medical University
        • Contact:
        • Principal Investigator:
          • Yaojun Yu, MD

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

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
Intervention / Treatment
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

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

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

Sir Run Run Shaw Hospital

Investigators

  • 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 (Estimated)

January 31, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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