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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Friendship Hospital
NOT_YET_RECRUITING
Beijing
Cancer Hospital, Peking University
NOT_YET_RECRUITING
Beijing
Chinese PLA General Hospita
NOT_YET_RECRUITING
Beijing
Peking Union Hospital
NOT_YET_RECRUITING
Beijing
Xiangya Hospital, Central South Universit
NOT_YET_RECRUITING
Changsha
Sichuan Cancer Hospital, University of Electronic Science and Technology of China
NOT_YET_RECRUITING
Chengdu
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Fujian Union Hospital, Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
The First Affiliated Hospital, Sun Yat-Sen University
NOT_YET_RECRUITING
Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University
RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University
NOT_YET_RECRUITING
Hangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital, Jilin University
NOT_YET_RECRUITING
Jilin
The First Affiliated Hospital, Ningbo University
NOT_YET_RECRUITING
Ningbo
The Affiliated Hospital, Qingdao University
NOT_YET_RECRUITING
Qingdao
Cancer Hospital, Fudan University
NOT_YET_RECRUITING
Shanghai
ChangHai Hospital, The Second Military Medical University
NOT_YET_RECRUITING
Shanghai
Shengjing Hospital, China Medical University
NOT_YET_RECRUITING
Shenyang
The Second Affiliated Hospital, Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Union Hospital, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Contact Information
Primary
Yifan Tong, PhD
tongyf@zju.edu.cn
+86-571-13732207321
Backup
Lingfei Li, bachelor
3196024@zju.edu.cn
+86-571-13588708122
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2025-06
Participants
Target number of participants: 570
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Sir Run Run Shaw Hospital

This content was sourced from clinicaltrials.gov