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

Rectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204497
• Other study ID #: SRRSH.SDT
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Sir Run Run Shaw Hospital
• Contact: Yifan Tong, PhD
• Phone: +86-571-13732207321
• Email: tongyf[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 570
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing
China	Cancer Hospital, Peking University	Beijing	Beijing
China	Chinese PLA General Hospita	Beijing	Beijing
China	Peking Union Hospital	Beijing	Beijing
China	Xiangya Hospital, Central South Universit	Changsha	Hunan
China	Sichuan Cancer Hospital, University of Electronic Science and Technology of China	Chengdu	Sichuan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Fujian Union Hospital, Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, Zhejiang University	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Jilin University	Jilin	Jilin
China	The First Affiliated Hospital, Ningbo University	Ningbo	Zhejiang
China	The Affiliated Hospital, Qingdao University	Qingdao	Shandong
China	Cancer Hospital, Fudan University	Shanghai	Shanghai
China	ChangHai Hospital, The Second Military Medical University	Shanghai	Shanghai
China	Shengjing Hospital, China Medical University	Shenyang	Liaoning
China	The Second Affiliated Hospital, Wenzhou Medical University	Wenzhou	Zhejiang
China	Union Hospital, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

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* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe complications within 90-day	Clavein-Dindo=III	Study group, from SDT to postoperative 90 days, Control group, from ileostomy to postoperative 90 days of reversal of stoma.
Secondary	Total complications	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
Secondary	Clinical anastomotic leakage	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
Secondary	Postoperative hospital stay	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
Secondary	Total medical Costs	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
Secondary	Quality of life evaluation	SF-8 scale	Study group, 90 days after SDT; Control group, 90 days after ileostomy