Optical Biopsy for Distal Margin in Low Rectal Cancer

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Device: Intra-operative frozen section; Device: Probe-based confocal laser endomicroscopy optical biopsy

• Registration Number: NCT04016948
• Lead Sponsor: Nanfang Hospital, 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.

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 Timeline

• Study Start: 2017-06-28
• Study First Submitted: 2017-07-26
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Study First Posted: 2019-07-12
• Last Update Posted: 2019-07-12
• Primary Completion: 2020-09-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-operative frozen section(IFS)	Intra-operative frozen section	Intra-operative frozen section will be performed for patients assigned to this group
Probe-based confocal laser endomicroscopy(pCLE)	Probe-based confocal laser endomicroscopy optical biopsy	Confocal laser endomicroscopy optical biopsy will be performed in surgery for patients assigned to this group

Primary Outcome Measures

Name	Time	Method
Accuracy of optical biopsy	One week after surgery	Accuracy of confocal laser endomicroscopy optical biopsy of distal margin is determined by the pathology result.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China