SEMS Placement Followed by Chemotherapy and Surgery for Obstructing Left-sided Colonic Cancer
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|ClinicalTrials.gov Identifier: NCT04039360|
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Beijing Chao Yang Hospital
Information provided by (Responsible Party):
Zhen Jun Wang, Beijing Chao Yang Hospital
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.
|Condition or disease||Intervention/treatment|
|Complication of Treatment||Combination Product: self-expanding metallic stent placement followed by neoadjuvant chemotherapy|
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 Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Self-expanding Metallic Stent Placement Followed by Neoadjuvant Chemotherapy and Scheduled Surgery for Treatment of Obstructing Left-sided Colonic Cancer|
|Actual Study Start Date :||May 1, 2014|
|Actual Primary Completion Date :||November 30, 2015|
|Actual Study Completion Date :||November 30, 2015|
- Combination Product: self-expanding metallic stent placement followed by neoadjuvant chemotherapy
Neoadjuvant chemotherapy was administered 1 week after successful SEMS placement and decompression for patient with obstructing left-sided colonic cancer. Patients received either three cycles of mFOLFOX6 repeated every 2 weeks or two cycles of CAPOX repeated every 3 weeks. Elective surgery was performed 2 weeks after completion of chemotherapy by experienced colorectal surgeons.
Primary Outcome Measures :
- stoma rate [ Time Frame: 3 years after operation ]stoma rate after surgery
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