Change of Circulating Tumor Cells Quantity in the Central Vein During Laparoscopic or Transanal Endoscopic Surgery for Rectal Cancer.

Sponsor
Sun Yat-sen University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05109130
Collaborator
(none)
100
1
47.4
2.1

Study Details

Study Description

Brief Summary

The primary purpose of this study is to compare the changes of circulating tumor cells (CTCs) at different time points in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection. Our secondary purpose is to explore the effects of perioperative circulating tumor cells on tumor recurrence and metastasis.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgical approach

Detailed Description

Mid-low rectal cancer is one of the common malignant tumors and the incidence has increased significantly in recent years. At present, surgery is still the most important and effective method for the treatment of mid-low rectal cancer. Traditional laparoscopic surgery and emerging transanal total mesorectal excision (TaTME) are the main methods. More than one-third of rectal cancer patients will eventually local recurrence and distant metastasis, which are the most important factors affecting prognosis. Circulating tumor cells may lead to distant metastasis, so the detection of CTCs in blood has important clinical significance in predicting recurrence and metastasis of rectal cancer and monitoring treatment response. Due to the different degrees of contact between distinct surgical methods, this may lead to an increase in the quantity of CTCs in the blood, which may affect the prognosis of patients. Therefore, the investigators conducted a randomized controlled study to compare the changes in the quantity of CTCs in the central vein before, during and after operation in rectal cancer patients undergoing transanal endoscopic or laparoscopic radical resection. To explore the effect of two surgical methods on the risk of micrometastasis, and to provide new ideas for the selection and improvement of rectal cancer treatment.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Sixth Affiliated Hospital, Sun Yat-sen University
Actual Study Start Date :
Oct 18, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
laparoscopic surgery

Procedure: Surgical approach
Different surgical methods for rectal cancer resection

Transanal endoscopic surgery

Procedure: Surgical approach
Different surgical methods for rectal cancer resection

Outcome Measures

Primary Outcome Measures

  1. Change of circulating tumor cells during laparoscopic or transanal endoscopic surgery [1 years]

    Determine the changes of circulating tumor cells at different time points in patients undergoing laparoscopic or transanal endoscopic radical resection of rectal cancer

Secondary Outcome Measures

  1. Disease free survival [3 years]

    Determine relationship of CTC numbers and local recurrence and distant metastasis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Mid-low rectal cancer.

  2. Single lesion.

  3. No metastasis.

Exclusion Criteria:
  1. History of malignant tumors.

  2. Acute bowel obstruction, bleeding or perforation.

  3. Tumor over 6cm in diameter or in severe adhesion with surrounded tissues.

  4. Severe other contradictions of surgery.

  5. Pregnant women will be excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong China 510655

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanhong Deng, Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05109130
Other Study ID Numbers:
  • GIHSYSU-20
First Posted:
Nov 5, 2021
Last Update Posted:
Nov 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yanhong Deng, Sun Yat-sen University, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2021