Clinical trial NCT04016948: Optical Biopsy for Distal Margin in Low Rectal Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: Rectal cancer
distal margin
confocal laser endomicroscopy
real-time
in vivo
optical biopsy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
name: Shenzhen Hospital of Southern Medical University
First posted: 2019-07-12
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Accuracy of optical biopsy
timeFrame: One week after surgery
Secondary outcomes:
measure: Sensitivity and Specificity
timeFrame: One week after surgery
measure: Operation related indexes
timeFrame: One week after surgery
measure: Postoperative function recovery
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jun Yan, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
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