SEMS Placement Followed by Chemotherapy and Surgery for Obstructing Left-sided Colonic Cancer

Completed

• Conditions: Complication of Treatment

• Registration Number: NCT04039360
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

This study aimed to evaluate the safety and feasibility of SEMS followed by neoadjuvant chemotherapy prior to elective surgery for obstructing left-sided colon cancer.

Detailed Description

Stoma is reported to be frequent in self-expanding metallic stent (SEMS) treated patients with obstructing left-sided colon cancer than in those with non-obstructing surgery. Retrospective study reported worse overall survival with SEMS and elective surgery than with emergency surgery in patients with left-sided malignant colon obstruction. In practice, intestinal wall edema following stent placement increases the difficulty of surgery, and this could be a major problem if the interval between stent insertion and surgery is short (1-2 weeks). The patients with obstructing left-sided colon cancer received SEMS treatment, and the recevied neoadjuvant chemotherapy prior to elective surgery.

Study Timeline

• Study Start: 2014-05-01
• Primary Completion: 2015-11-30
• Study Completion: 2015-11-30
• Status Verified: 2019-07
• Study First Submitted: 2019-07-27
• Study First Submitted QC: 2019-07-30
• Last Update Submitted: 2019-07-30
• Study First Posted: 2019-07-31
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1. histologically proven adenocarcinoma located in the left colon (between the splenic flexure and 15 cm proximal to the anal margin)
2. Eastern Cooperative Oncology Group (ECOG) performance status of from 0 to 2

Exclusion Criteria

1. history of any other cancer
2. multiple primary colorectal cancers
3. distant metastases
4. hereditary nonpolyposis colorectal cancer
5. familial adenomatous polyposis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stoma rate	3 years after operation	stoma rate after surgery