NCT04016948

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
2 years until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

3.2 years

First QC Date

July 26, 2017

Last Update Submit

July 9, 2019

Conditions

Rectal Cancer

Keywords

Rectal cancerdistal marginconfocal laser endomicroscopyreal-timein vivooptical biopsy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of optical biopsy

    Accuracy of confocal laser endomicroscopy optical biopsy of distal margin is determined by the pathology result.

    One week after surgery

Secondary Outcomes (3)

  • Sensitivity and Specificity

    One week after surgery

  • Operation related indexes

    One week after surgery

  • Postoperative function recovery

    Up to 12 months

Study Arms (2)

Probe-based confocal laser endomicroscopy(pCLE)

EXPERIMENTAL

Confocal laser endomicroscopy optical biopsy will be performed in surgery for patients assigned to this group

Device: Probe-based confocal laser endomicroscopy optical biopsy

Intra-operative frozen section(IFS)

ACTIVE COMPARATOR

Intra-operative frozen section will be performed for patients assigned to this group

Device: Intra-operative frozen section

Interventions

Probe-based confocal laser endomicroscopy optical biopsyDEVICE

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.

Probe-based confocal laser endomicroscopy(pCLE)
Intra-operative frozen sectionDEVICE

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)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510-515, China

Location

Related Publications (8)

  • 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.

    PMID: 15729069BACKGROUND

  • 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.

    PMID: 25982468BACKGROUND

  • 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.

    PMID: 16843068BACKGROUND

  • 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.

    PMID: 18063417BACKGROUND

  • 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.

    PMID: 24473908BACKGROUND

  • 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.

    PMID: 21193460BACKGROUND

  • 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.

    PMID: 21038291BACKGROUND

  • 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.

    PMID: 36632126DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jun Yan, M.D., Ph.D

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 12, 2019

Study Start

June 28, 2017

Primary Completion

September 1, 2020

Study Completion

May 1, 2021

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)