Status:
UNKNOWN
Optical Biopsy for Distal Margin in Low Rectal Cancer
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Southern Medical University, China
Shenzhen Hospital of Southern Medical University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
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 rec...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04016948
Start Date
June 28 2017
End Date
May 1 2021
Last Update
July 12 2019
Active Locations (1)
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1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510-515