Clinical trial · Interventional
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
NCT04016948CI-TRIAL-00039473unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-operative frozen section | Device | — | UNRESOLVED |
| Probe-based confocal laser endomicroscopy optical biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Probe-based confocal laser endomicroscopy(pCLE)
- description
- Confocal laser endomicroscopy optical biopsy will be performed in surgery for patients assigned to this group
- interventionNames
- Device: Probe-based confocal laser endomicroscopy optical biopsy
- type
- ACTIVE_COMPARATOR
- label
- Intra-operative frozen section(IFS)
- description
- Intra-operative frozen section will be performed for patients assigned to this group
- interventionNames
- Device: Intra-operative frozen section
Primary outcomes (1)
- measure
- Accuracy of optical biopsy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDRullier 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 15729069
- BACKGROUNDGomes 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 25982468
- BACKGROUNDKiesslich 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 16843068
- BACKGROUNDPech 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 18063417
- BACKGROUNDLi 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 24473908
- BACKGROUNDLi 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 21193460
- BACKGROUNDXie 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.