Clinical trial · Interventional
Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy
- 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)
Confocal endomicroscopy is an emerging technique that allows in vivo imaging of cells and tissue structures of the gastrointestinal mucosa, with a magnification of about 1000 times, guiding optical biopsies in real time. Confocal endomicroscopy represents technique that combines conventional white light image with the confocal microscope probe, thereby allowing examination of the surface epithelium in vivo and histological diagnosis during endoscopy. Among the applications already established for its use, stand out diagnosis of Barrett's esophagus, gastric atrophy and intestinal metaplasia, celiac disease, differentiation of hyperplastic adenomatous polyps of the colon, microscopic colitis and follow-up of patients with inflammatory disease, reducing the need for endoscopic biopsies. The CLE can still detect molecular changes effectively improving the endoscopic diagnosis. This pilot project consists of 07 subprojects which the technology of confocal endomicroscopia will be evaluated and compared with the histological results of biopsy or surgical specimens: 1\. confocal endomicroscopy for the diagnosis of high-grade dysplasia and superficial esophageal adenocarcinoma in patients with Barrett's esophagus 2 Diagnosis of superficial esophageal squamous cell carcinoma in patients with head and neck cancer by confocal endomicroscopy 3 Detect the presence of premalignant lesions in the gastric stump in patients with reflux alkaline gastritis after partial gastrectomy 4. detect lesions in the gastric mucosa of patients with familial history of gastric cancer 5 Biliary Strictures: differential diagnosis by confocal endomicroscopia 6 confocal Endomicroscopy of cystic neoplasms of the pancreas 7 Contribution of confocal endomicroscopy for the differential diagnosis of colorectal polyps The project aims to deploy the structure of the Confocal endomicroscopy Endoscopy ICESP, for performing in vivo histological examinations of the digestive tract, biliary tract and pancreas. All research groups involved in the early detection of tumors of the esophagus, stomach, biliary tract, pancreas, colon and rectum may benefit from the implementation of this methodology.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Biliary Duct Stricture | — | UNRESOLVED | — |
| Colorectal Polyps | — | UNRESOLVED | — |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastric Antrectomy Partial | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Duct Stricture | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal endomicroscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Confocal endomicroscopy
- description
- Pts will be submitted to confocal endomicroscopy examination of the area of interest during endoscopy. A presumptive diagnosis will be made. This diagnosis will be compared to the definitive histologic diagnosis provided by endoscopic biopsies of the area of interest.
- interventionNames
- Procedure: Confocal endomicroscopy
Primary outcomes (1)
- measure
- accuracy of confocal endomicroscopy
- timeFrame
- Less than 7 days
- description
- Diagnostic accuracy of confocal endomicroscopy for the early detection of tumors of the digestive tract
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Minimum age of 18 years old * Clinical conditions for the proposed endoscopic procedure * Sign the informed consent Exclusion Criteria: * History of anaphylactic reactions to fluorescein
References
Publications (7)
- RESULTSafatle-Ribeiro AV, Baba ER, Faraj SF, Rios JT, de Lima MS, Martins BC, Geiger SN, Pennacchi C, Gusman C, Kawaguti FS, Uemura RS, de Melo ES, Ribeiro U Jr, Maluf-Filho F. Diagnostic accuracy of probe-based confocal laser endomicroscopy in Lugol-unstained esophageal superficial lesions of patients with head and neck cancer. Gastrointest Endosc. 2017 Jun;85(6):1195-1207. doi: 10.1016/j.gie.2016.09.031. Epub 2016 Sep 30. PMID 27697445
- RESULTSafatle-Ribeiro AV, Ryoka Baba E, Corsato Scomparin R, Friedrich Faraj S, Simas de Lima M, Lenz L, Costa Martins B, Gusmon C, Shiguehissa Kawaguti F, Pennacchi C, Zilberstein B, Ribeiro U Jr, Maluf-Filho F. Probe-based confocal endomicroscopy is accurate for differentiating gastric lesions in patients in a Western center. Chin J Cancer Res. 2018 Oct;30(5):546-552. doi: 10.21147/j.issn.1000-9604.2018.05.08. PMID 30510366
- RESULTBaba ER, Safatle-Ribeiro AV, Paduani GF, Giovannini M, Maluf-Filho F. Probe-based confocal laser endomicroscopy for the differential diagnosis of gastric tubular adenoma and intestinal metaplasia in a patient with severe atrophic pangastritis. Gastrointest Endosc. 2016 Jul;84(1):183. doi: 10.1016/j.gie.2016.02.033. Epub 2016 Mar 3. No abstract available. PMID 26949002
- RESULTSafatle-Ribeiro AV, Marques CFS, Pires C, Arraes L, Baba ER, Meirelles L, Kawaguti FS, da Costa Martins B, Lenz LT, de Lima MS, Gusmon-Oliveira CC, Ribeiro U Jr, Maluf-Filho F, Nahas SC. Diagnosis of Clinical Complete Response by Probe-Based Confocal Laser Endomicroscopy (pCLE) After Chemoradiation for Advanced Rectal Cancer. J Gastrointest Surg. 2021 Feb;25(2):357-368. doi: 10.1007/s11605-020-04878-y. Epub 2021 Jan 14. PMID 33443686
- RESULTScomparin RC, Bento LH, Batista CP, Martins BC, Lenz L, Baba ER, Safatle-Ribeiro AV, Maluf-Filho F. Application of confocal endomicroscopy in the diagnostic elucidation of pancreatic cyst. Rev Assoc Med Bras (1992). 2018 Oct;64(10):885-887. doi: 10.1590/1806-9282.64.10.885. No abstract available. PMID 30517234