Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
146 participants
INTERVENTIONAL
2017-06-28
2021-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Probe-based confocal laser endomicroscopy(pCLE)
Confocal laser endomicroscopy optical biopsy will be performed in surgery for patients assigned to this group
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.
Intra-operative frozen section(IFS)
Intra-operative frozen section will be performed for patients assigned to this group
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Southern Medical University, China
OTHER
Shenzhen Hospital of Southern Medical University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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Jun Yan, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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References
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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.
Tan J, Ji HL, Hu YW, Li ZM, Zhuang BX, Deng HJ, Wang YN, Zheng JX, Jiang W, Yan J. Real-time in vivo distal margin selection using confocal laser endomicroscopy in transanal total mesorectal excision for rectal cancer. World J Gastrointest Surg. 2022 Dec 27;14(12):1375-1386. doi: 10.4240/wjgs.v14.i12.1375.
Other Identifiers
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yanjun
Identifier Type: -
Identifier Source: org_study_id
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