Skip to content

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

Sixth Affiliated Hospital, Sun Yat-sen University

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05109130
Enrollment
100
Registered
2021-11-05
Start date
2021-10-18
Completion date
2025-10-18
Last updated
2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

rectal cancer, CTCs

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.

Interventions

Different surgical methods for rectal cancer resection

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of circulating tumor cells during laparoscopic or transanal endoscopic surgery1 yearsTo 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

MeasureTime frameDescription
Disease free survival3 yearsDetermine relationship of CTC numbers and local recurrence and distant metastasis

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026