Status:
RECRUITING
The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients
Lead Sponsor:
Sir Run Run Shaw Hospital
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
NA
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, par...
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 ...
Eligibility Criteria
Inclusion
- Rectal adenocarcinoma confirmed pathologically.
- Rectal cancer patients with high-risk of anastomotic leakage(AL).
- Age from over 18 to under 80 years.
- Performance status of 0/1 on ECOG (Eastern Cooperative Oncology Group) scale.
- ASA (American Society of Anesthesiology) score class I, II, or III.
- Written informed consent.
- Definition of high-risk of AL (one of them):
- Preoperative body mass index (BMI) ≥30 kg/m2;
- Long-term use of glucocorticoids before surgery (≥2 weeks);
- 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;
- Preoperative neoadjuvant radiotherapy;
- Distance between tumor and anal anus (baseline MRI) ≤7cm
- 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
- History of previous rectectomy, except endoscopic mucosal resection or endoscopic submucosal dissection.
- Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active colitis ulcerosa.
- History of unstable angina, myocardial infarction, cerebrovascular accident within the past six months.
- 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.
- Patients with severe complications who do not tolerate surgery or need emergency surgery due to complication (bleeding, obstruction or perforation)
- 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).
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT06204497
Start Date
January 31 2024
End Date
June 1 2025
Last Update
January 12 2024
Active Locations (20)
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1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100000
2
Cancer Hospital, Peking University
Beijing, Beijing Municipality, China, 100000
3
Peking Union Hospital
Beijing, Beijing Municipality, China, 100000
4
Chinese PLA General Hospita
Beijing, Beijing Municipality, China, 310000