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

Sixth Affiliated Hospital, Sun Yat-sen University

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Laparoscopic Surgery; Rectal Neoplasms; Neoplastic Cells, Circulating; Transanal Endoscopic Surgery
• Intervention / Treatment: 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 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
laparoscopic surgery; Laparoscopic total mesorectal excision was performed on the enrolled patients.	Procedure: Surgical approach; Different surgical methods for rectal cancer resection
Transanal endoscopic surgery; Transanal total mesorectal excision was performed on the enrolled patients.	Procedure: Surgical approach; Different surgical methods for rectal cancer resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	Determine relationship of CTC numbers and local recurrence and distant metastasis	3 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Liang Huang, Sun Yat-sen University Sixth Affiliated Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): October 25, 2022
• Study Completion (Anticipated): October 18, 2025

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: rectal cancer; CTCs
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Rectal Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: GIHSYSU-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No