COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04039360
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Information provided by (Responsible Party):
Zhen Jun Wang, 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.

Condition or disease Intervention/treatment
Complication of Treatment Combination Product: self-expanding metallic stent placement followed by neoadjuvant chemotherapy

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Intervention Details:
  • 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 :
  1. stoma rate [ Time Frame: 3 years after operation ]
    stoma rate after surgery

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
11 patients included seven (63.6%) men and four (36.4%) women. The median age of the patients was 67 years (range, 43-72 years)

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
Layout table for additonal information
Responsible Party: Zhen Jun Wang, Chairman of General Surgery, Beijing Chao Yang Hospital Identifier: NCT04039360    
Other Study ID Numbers: SEMS-NCS-01
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhen Jun Wang, Beijing Chao Yang Hospital:
Left-sided colonic tumor
Intestinal obstruction
Self-expanding metallic stent
Neoadjuvant chemotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases