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Optical Biopsy for Distal Margin in Low Rectal Cancer

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ClinicalTrials.gov Identifier: NCT04016948
Recruitment Status : Active, not recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Southern Medical University, China
Shenzhen Hospital of Southern Medical University
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Device: Probe-based confocal laser endomicroscopy optical biopsy Device: Intra-operative frozen section Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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
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.

Active Comparator: Intra-operative frozen section(IFS)
Intra-operative frozen section will be performed for patients assigned to this group
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Operation related indexes [ Time Frame: One week after surgery ]
    Operation time in minutes

  3. Postoperative function recovery [ Time Frame: Up to 12 months ]
    Defecation and sphincter function will be combined to report Wexner score.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016948


Locations
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China, Guangdong
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510-515
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Southern Medical University, China
Shenzhen Hospital of Southern Medical University
Investigators
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Principal Investigator: Jun Yan, M.D., Ph.D Nanfang Hospital of Southern Medical University

Publications:

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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT04016948     History of Changes
Other Study ID Numbers: yanjun
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nanfang Hospital of Southern Medical University:
Rectal cancer
distal margin
confocal laser endomicroscopy
real-time
in vivo
optical biopsy

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases