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Active, not recruitingNCT05109130Updated Apr 13, 2023

Change of Circulating Tumor Cells During Laparoscopic or Transanal Endoscopic Surgery for Rectal Cancer.

An observational study in Rectal Neoplasms, Neoplastic Cells, Circulating and Laparoscopic Surgery, sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-13.

Sponsored by Sun Yat-sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 occur 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 the 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 evidence for the selection and improvement of rectal cancer treatment.

02

Conditions studied

  • Rectal Neoplasms
  • Neoplastic Cells, Circulating
  • Laparoscopic Surgery
  • Transanal Endoscopic Surgery

Keywords

  • rectal cancer
  • CTCs
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 100 is below the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

100 rectal cancer patients will be enrolled. Patients must be older than 18 years.

Inclusion criteria

  1. Mid-low rectal cancer.
  2. Single lesion.
  3. No metastasis.
  4. Clinical Stage T2-3, N0-1.

Exclusion criteria

Exclusion Criteria:

  1. History of malignant tumors.
  2. Acute bowel obstruction, bleeding or perforation.
  3. Received neoadjuvant treatment.
  4. Tumor over 6cm in diameter or in severe adhesion with surrounded tissues.
  5. Severe other contradictions of surgery.
  6. Pregnant women will be excluded.

Exit Criteria:

  1. The patient suffered from massive hemorrhage.
  2. The operation mode needs to be changed according to the patient's condition.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • laparoscopic surgery

    Laparoscopic total mesorectal excision was performed on the enrolled patients.

    Procedure: Surgical approach

  • Transanal endoscopic surgery

    Transanal total mesorectal excision was performed on the enrolled patients.

    Procedure: Surgical approach

Interventions

  • ProcedureSurgical approach

    Different surgical methods for rectal cancer resection

06

What researchers measure

Primary outcomes

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

    To determine the changes of circulating tumor cells in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection before operation and 5 days after operation.

    Time frame: 1 years

Secondary outcomes

  1. Disease free survival

    Determine relationship of CTC numbers and local recurrence and distant metastasis

    Time frame: 3 years

07

Study locations

1 site
  • Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
    Guangzhou, Guangdong 510655, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05109130
Lead sponsor
Sun Yat-sen University
Responsible party
Yanhong Deng (Sun Yat-sen University, Sun Yat-sen University) — Principal investigator
First posted
Nov 5, 2021
Start date
Oct 18, 2021
Primary completion
Oct 25, 2022
Completion
Oct 18, 2025 (estimated)
Last update
Apr 13, 2023

Study contacts

Liang Huang
principal investigator · Sun Yat-sen University Sixth Affiliated Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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