Optical Biopsy for Distal Margin in Low Rectal Cancer

A Multicenter Randomized Study of Real-time In-vivo Confocal Laser Endomicroscopy Optical Biopsy for Distal Margin in Low Rectal Cancer Compared to Intraoperative Frozen Section

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.

Study Overview

Detailed Description

In low rectal cancer surgery, how to select the precise dissection plane and optimal surgical procedure is an important challenge for surgeons. In current clinic, surgeons select dissection plane by a comprehensive judgment of pre-operative pelvis MRI, colonoscopy and digital rectal examination, then through submitting the "doughnut" after cutting and anastomosis to intra-operative frozen section (IFS) to definite whether there is residual tumor in distal margin (DM). However, IFS can only make diagnosis using the tissue specimen in vitro and time-consuming. Once the IFS confirm positive margin, it always means anal resection should be implemented to ensure radical treatment. Therefore, if there is a real-time in situ examination method to evaluate DM in vivo, it will bring great benefits to both surgeons and patients.

Confocal laser endomicroscopy (CLE) had been widely used in medical field to diagnose colorectal disease, but it is seldom applied in surgical filed especially in rectal cancer to make optical biopsy and help surgical decision-making. Therefore, the investigators hypothesize that CLE can real-time in situ evaluate DM during surgery in rectal cancer and its accuracy is non-inferior to intra-operative frozen section.

In this study, the investigators will randomly assign patients to the experimental group (CLE optical biopsy) and control group (IFS). Using H-E staining pathological diagnosis as golden standard, the accuracy, sensitivity and specificity of both CLE optical biopsy and IFS will be evaluated and compared. And the investigators will also evaluate patients' postoperative urinary function, defection function and quality of life through a year follow-up.

Study Type

Interventional

Enrollment (Anticipated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510-515
        • Nanfang Hospital, Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages from 18 to 70 years.
  • Rectal tumor confirmed pathologically by endoscopic biopsy.
  • The distance from lower edge of tumor to the dentate line is less than 5cm.
  • Plan to perform curative resection.
  • ASA(American Society of Anesthesiology)score class I,II,or III.
  • Able to provide written informed consent.

Exclusion Criteria:

  • Intestinal perforation or acute intestinal obstruction.
  • Multiple distant metastasis and can not R0 resection.
  • T4b according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
  • Pregnancy or breastfeeding.
  • Impaired renal function
  • American Society of Anesthesiology score (ASA) class IV or V.
  • Unable or refuse to provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Probe-based confocal laser endomicroscopy(pCLE)
Confocal laser endomicroscopy optical biopsy will be performed in surgery for patients assigned to this group
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.
ACTIVE_COMPARATOR: Intra-operative frozen section(IFS)
Intra-operative frozen section will be performed for patients assigned to this group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of optical biopsy
Time Frame: One week after surgery
Accuracy of confocal laser endomicroscopy optical biopsy of distal margin is determined by the pathology result.
One week after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: One week after surgery
Sensitivity and specificity of confocal laser endomicroscopy optical biopsy of distal margin are determined by the pathology result.
One week after surgery
Operation related indexes
Time Frame: One week after surgery
Operation time in minutes
One week after surgery
Postoperative function recovery
Time Frame: Up to 12 months
Defecation and sphincter function will be combined to report Wexner score.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 28, 2017

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

July 9, 2019

First Posted (ACTUAL)

July 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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