MedTrace Logo

Optical Biopsy for Distal Margin in Low Rectal Cancer

NCT04016948 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2019-07-12

No results posted yet for this study

Summary

This is a multi-center prospective randomized controlled study. In this study, the investigators will use confocal laser endomicroscopy to make real-time in vivo optical biopsy of distal margin in rectal cancer surgery and help surgeons to make surgical decision.The investigators also assess the accuracy of CLE optical biopsy, compared with intra-operative frozen section.

Conditions

Interventions

DEVICE

Probe-based confocal laser endomicroscopy optical biopsy

In the pCLE group, after intravenous injection of fluorescein, the optical biopsy will be performed, using a confocal miniprobe, to exam the rectal mucosa when the rectum transection is ready. The raters will analyse the CLE images to determine whether the distal margin is positive. In the IFS group, intra-operative frozen section will be performed at the site of distal margin after the rectum transection.

DEVICE

Intra-operative frozen section

In the pCLE group, after intravenous injection of fluorescein, the optical biopsy will be performed, using a confocal miniprobe, to exam the rectal mucosa when the rectum transection is ready. The raters will analyse the CLE images to determine whether the distal margin is positive. In the IFS group, intra-operative frozen section will be performed at the site of distal margin after the rectum transection.

Sponsors & Collaborators

  • Southern Medical University, China

    collaborator OTHER

  • Shenzhen Hospital of Southern Medical University

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Jun Yan, M.D., Ph.D · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2020-09-01
Completion
2021-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04016948 on ClinicalTrials.gov