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

Last updated: January 10, 2024
Sponsor: Sir Run Run Shaw Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Colorectal Cancer

Rectal Cancer

Treatment

Stent-based Diverting Technique

Clinical Study ID

NCT06204497
SRRSH.SDT
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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):
  7. Preoperative body mass index (BMI) ≥30 kg/m2;
  8. Long-term use of glucocorticoids before surgery (≥2 weeks);
  9. Poor general condition: Preoperative serum albumin was less than 30.0g/L aftersupportive treatment; or Preoperative renal replacement therapy (bloodpurification/hemodialysis) is required; or diabetes;
  10. Preoperative neoadjuvant radiotherapy;
  11. Distance between tumor and anal anus (baseline MRI) ≤7cm
  12. The number of stapler used to cut the rectum during the operation ≥3; or the defect ofanastomosis is observed; or Intraoperative leak test was positive.

Exclusion

Exclusion Criteria:

  1. History of previous rectectomy, except endoscopic mucosal resection or endoscopicsubmucosal 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 thepast six months.
  4. Groups who are particularly vulnerable include those who suffer from mental disease,cognitive impairment, severe illness, adolescents, illiterates, women during pregnancyor breast-feeding, etc.
  5. Patients with severe complications who do not tolerate surgery or need emergencysurgery due to complication (bleeding, obstruction or perforation)
  6. Unable ot radical resection, or underwent Miles or Hartmann or TaTME procedure, orrequirement of simultaneous surgery for other disease (except the gallblader orappendix due to benign lesion).

Study Design

Total Participants: 570
Treatment Group(s): 1
Primary Treatment: Stent-based Diverting Technique
Phase:
Study Start date:
January 31, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Beijing Friendship Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • Cancer Hospital, Peking University

    Beijing, Beijing 100000
    China

    Site Not Available

  • Chinese PLA General Hospita

    Beijing, Beijing 310000
    China

    Site Not Available

  • Peking Union Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • Fujian Union Hospital, Fujian Medical University

    Fuzhou, Fujian 350000
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Union Hospital, Huazhong University of Science and Technology

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Xiangya Hospital, Central South Universit

    Changsha, Hunan 410000
    China

    Site Not Available

  • The First Affiliated Hospital, Jilin University

    Jilin, Jilin 132000
    China

    Site Not Available

  • Shengjing Hospital, China Medical University

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • The Affiliated Hospital, Qingdao University

    Qingdao, Shandong 266000
    China

    Site Not Available

  • Cancer Hospital, Fudan University

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • ChangHai Hospital, The Second Military Medical University

    Shanghai, Shanghai 200000
    China

    Site Not Available

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

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • The First Affiliated Hospital, Ningbo University

    Ningbo, Zhejiang 315000
    China

    Site Not Available

  • The Second Affiliated Hospital, Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

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