Clinical trial · Interventional
Endocytoscopy and Colorectal Neoplasia
The Role of in Vivo Real Time Endocytoscopy in Diagnosing Colorectal Neoplasia
NCT02324374CI-TRIAL-00063421completedN/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 will be a feasibility study to evaluate the role of endocytoscopy in classifying colorectal polyps in vivo. The primary outcomes will be to determine the key endocytoscopy image features of neoplastic and non-neoplastic colorectal polyps. The target population will include adult subjects undergoing screening and surveillance colonoscopies.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endocystoscopy During Colonoscopy | Device | — | UNRESOLVED |
| Endocytoscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endocytoscopy During Colonoscopy
- description
- Colonoscopies will be performed as per routine practice. When a colorectal lesion is found that would normally require biopsy or polypectomy; the lesion will be evaluated by chromoendoscopy with the application of 10 ml 1% methylene blue followed by the inspection with the endocytoscope at both magnifications (450X and 1100X). The endocytoscopic images of the abnormal area will be recorded prior to biopsy or removal of the suspicious tissue. For each lesion, a matching endocytoscopy image from normal adjacent tissue will also be obtained, at least 5cm away from the suspect site, but within the same segment of intestine (e.g. ascending colon). No biopsy will be obtained from normal tissue, and this will be assumed to be normal. Following image acquisition, the lesion will be biopsied or removed as per standard clinical care.
- interventionNames
- Device: Endocystoscopy During Colonoscopy
- Device: Endocytoscope
Primary outcomes (1)
- measure
- Unblinded Analysis of Endocytoscopic Images of Colorectal Lesions (Technical quality of the images will be compared to histology and rated on a scale of 1-5 (1-worst, 3- acceptable, 5-being equal to histology)
- timeFrame
- 30 Days (from Colonoscopy)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: • Age above 18, any patient undergoing screening or surveillance colonoscopy. Exclusion Criteria: * Pregnancy * Unwillingness to consent * Lack of any pathological state that would require biopsy at the time of endoscopy (will be considered "screen failure" since this will not be known until after consent is obtained and sedated endoscopy performed).
References
Publications (16)
- BACKGROUNDHawk ET, Levin B. Colorectal cancer prevention. J Clin Oncol. 2005 Jan 10;23(2):378-91. doi: 10.1200/JCO.2005.08.097. PMID 15637400
- BACKGROUNDHurlstone DP, Fujii T, Lobo AJ. Early detection of colorectal cancer using high-magnification chromoscopic colonoscopy. Br J Surg. 2002 Mar;89(3):272-82. doi: 10.1046/j.0007-1323.2001.02040.x. PMID 11872049
- BACKGROUNDHurlstone DP, Cross SS, Slater R, Sanders DS, Brown S. Detecting diminutive colorectal lesions at colonoscopy: a randomised controlled trial of pan-colonic versus targeted chromoscopy. Gut. 2004 Mar;53(3):376-80. doi: 10.1136/gut.2003.029868. PMID 14960519
- BACKGROUNDKiesslich R, Fritsch J, Holtmann M, Koehler HH, Stolte M, Kanzler S, Nafe B, Jung M, Galle PR, Neurath MF. Methylene blue-aided chromoendoscopy for the detection of intraepithelial neoplasia and colon cancer in ulcerative colitis. Gastroenterology. 2003 Apr;124(4):880-8. doi: 10.1053/gast.2003.50146. PMID 12671882
- BACKGROUNDKiesslich R, Burg J, Vieth M, Gnaendiger J, Enders M, Delaney P, Polglase A, McLaren W, Janell D, Thomas S, Nafe B, Galle PR, Neurath MF. Confocal laser endoscopy for diagnosing intraepithelial neoplasias and colorectal cancer in vivo. Gastroenterology. 2004 Sep;127(3):706-13. doi: 10.1053/j.gastro.2004.06.050. PMID 15362025
- BACKGROUNDSakashita M, Inoue H, Kashida H, Tanaka J, Cho JY, Satodate H, Hidaka E, Yoshida T, Fukami N, Tamegai Y, Shiokawa A, Kudo S. Virtual histology of colorectal lesions using laser-scanning confocal microscopy. Endoscopy. 2003 Dec;35(12):1033-8. doi: 10.1055/s-2003-44595. PMID 14648417
- BACKGROUNDPolglase AL, McLaren WJ, Skinner SA, Kiesslich R, Neurath MF, Delaney PM. A fluorescence confocal endomicroscope for in vivo microscopy of the upper- and the lower-GI tract. Gastrointest Endosc. 2005 Nov;62(5):686-95. doi: 10.1016/j.gie.2005.05.021.