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

Active, not recruiting

• Conditions: Rectal Neoplasms; Laparoscopic Surgery; Neoplastic Cells, Circulating; Transanal Endoscopic Surgery
• Interventions: Procedure: Surgical approach

• Registration Number: NCT05109130
• Lead Sponsor: Sun Yat-sen University

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.

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 Timeline

• Study Start: 2021-10-18
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-05
• Primary Completion: 2022-10-25
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13
• Study Completion: 2025-10-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laparoscopic surgery	Surgical approach	Laparoscopic total mesorectal excision was performed on the enrolled patients.
Transanal endoscopic surgery	Surgical approach	Transanal total mesorectal excision was performed on the enrolled patients.

Primary Outcome Measures

Name	Time	Method
Change of circulating tumor cells during laparoscopic or transanal endoscopic surgery	1 years	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.

Secondary Outcome Measures

Name	Time	Method
Disease free survival	3 years	Determine relationship of CTC numbers and local recurrence and distant metastasis

Trial Locations

Locations (1)

Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China