Clinical trial NCT06204497: The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Neoplasms
Keywords: Stent-based diverting technique
Ileostomy
Complication
Anastomotic leakage
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients who were enrolled will either undergo ileostomy or SDT after the removal of the rectal tumor, which will be decided by chance.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of severe complications within 90-day
timeFrame: Study group, from SDT to postoperative 90 days, Control group, from ileostomy to postoperative 90 days of reversal of stoma.
Secondary outcomes:
measure: Total complications
timeFrame: 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
measure: Clinical anastomotic leakage
timeFrame: 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
measure: Postoperative hospital stay
timeFrame: 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
measure: Total medical Costs
timeFrame: 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
measure: Quality of life evaluation
timeFrame: Study group, 90 days after SDT; Control group, 90 days after ileostomy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital, Peking University
state: Beijing
city: Beijing
country: China
facility: Peking Union Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospita
state: Beijing
city: Fuzhou
country: China
facility: Fujian Union Hospital, Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Central South Universit
state: Hunan
city: Jilin
country: China
facility: The First Affiliated Hospital, Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital, China Medical University
state: Liaoning
city: Qingdao
country: China
facility: The Affiliated Hospital, Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Cancer Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: ChangHai Hospital, The Second Military Medical University
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer Hospital, University of Electronic Science and Technology of China
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliated Hospital, Ningbo University
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital, Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: XiuJun Cai, MD
role: PRINCIPAL_INVESTIGATOR
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