- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016948
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510-515
- Nanfang Hospital, Southern Medical University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of optical biopsy
Time Frame: One week after surgery
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Accuracy of confocal laser endomicroscopy optical biopsy of distal margin is determined by the pathology result.
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One week after surgery
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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.
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One week after surgery
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Operation related indexes
Time Frame: One week after surgery
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Operation time in minutes
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One week after surgery
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Postoperative function recovery
Time Frame: Up to 12 months
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Defecation and sphincter function will be combined to report Wexner score.
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Up to 12 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- Rullier E, Laurent C, Bretagnol F, Rullier A, Vendrely V, Zerbib F. Sphincter-saving resection for all rectal carcinomas: the end of the 2-cm distal rule. Ann Surg. 2005 Mar;241(3):465-9. doi: 10.1097/01.sla.0000154551.06768.e1.
- Gomes RM, Bhandare M, Desouza A, Bal M, Saklani AP. Role of intraoperative frozen section for assessing distal resection margin after anterior resection. Int J Colorectal Dis. 2015 Aug;30(8):1081-9. doi: 10.1007/s00384-015-2244-4. Epub 2015 May 16.
- Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. doi: 10.1016/j.cgh.2006.05.010. Epub 2006 Jul 13.
- Pech O, Rabenstein T, Manner H, Petrone MC, Pohl J, Vieth M, Stolte M, Ell C. Confocal laser endomicroscopy for in vivo diagnosis of early squamous cell carcinoma in the esophagus. Clin Gastroenterol Hepatol. 2008 Jan;6(1):89-94. doi: 10.1016/j.cgh.2007.10.013. Epub 2007 Dec 11.
- Li Z, Zuo XL, Yu T, Gu XM, Zhou CJ, Li CQ, Ji R, Li YQ. Confocal laser endomicroscopy for in vivo detection of gastric intestinal metaplasia: a randomized controlled trial. Endoscopy. 2014 Apr;46(4):282-90. doi: 10.1055/s-0033-1359215. Epub 2014 Jan 28.
- Li WB, Zuo XL, Li CQ, Zuo F, Gu XM, Yu T, Chu CL, Zhang TG, Li YQ. Diagnostic value of confocal laser endomicroscopy for gastric superficial cancerous lesions. Gut. 2011 Mar;60(3):299-306. doi: 10.1136/gut.2010.223586. Epub 2010 Dec 30.
- Xie XJ, Li CQ, Zuo XL, Yu T, Gu XM, Li Z, Ji R, Wang Q, Li YQ. Differentiation of colonic polyps by confocal laser endomicroscopy. Endoscopy. 2011 Feb;43(2):87-93. doi: 10.1055/s-0030-1255919. Epub 2010 Oct 29.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- yanjun
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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