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

NCT05109130 | Unknown

• 1 other identifier: GIHSYSU-20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

rectal cancer; CTCs

Outcome Measures

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.

  1 years

Secondary Outcomes (1)

• Disease free survival

  3 years

Study Arms (2)

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

Surgical approach PROCEDURE

Different surgical methods for rectal cancer resection

Transanal endoscopic surgery; laparoscopic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• History of malignant tumors.
• Acute bowel obstruction, bleeding or perforation.
• Received neoadjuvant treatment.
• Tumor over 6cm in diameter or in severe adhesion with surrounded tissues.
• Severe other contradictions of surgery.
• Pregnant women will be excluded.
• Exit Criteria:
• The patient suffered from massive hemorrhage.
• The operation mode needs to be changed according to the patient's condition.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liang Huang

  Sun Yat-sen University Sixth Affiliated Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: October 18, 2021
• Primary Completion: October 25, 2022
• Study Completion: October 18, 2025
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

CN (1)