Clinical trial · Interventional
The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE
The Prevalence, Risk Factors and Optimal Biopsy Protocol of Barrett's Esophagus in Taiwan - A Prospective Randomized Study
NCT05818072CI-TRIAL-00066355recruitingN/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)
Detections of goblet cells and dysplasia are crucial for diagnosis and determining the surveillance program of Barrett's esophagus (BE). However, the optimal biopsy numbers and their yield rates of intestinal metaplasia (IM) and dysplasia are still uncertain, especially in Asia. The aim of this study was to determine the optimal biopsy protocol of BE.
Conditions
Conditions (2)
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's Esophagus | — | UNRESOLVED | — |
| Intestinal Metaplasia | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopy | Device | — | UNRESOLVED |
| One biopsy | Procedure | — | UNRESOLVED |
| Seattle protocol | Procedure | — | UNRESOLVED |
| Three biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- One biopsy
- description
- Obtain one biopsy specimen at the proximal part of the the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus
- interventionNames
- Procedure: One biopsy
- Device: Endoscopy
- type
- ACTIVE_COMPARATOR
- label
- Three biopsy
- description
- Obtain three biopsy specimens at the proximal, middle and distal part of the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus
- interventionNames
- Procedure: Three biopsy
- Device: Endoscopy
- type
- SHAM_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Adults with columnar-lined esophagus Exclusion Criteria: * A prior history of endoscopic treatment for Barrett's Esophagus * A prior history of upper gastrointestinal malignancy * A prior history of total or subtotal gastrectomy * Esophageal varices noted during the procedure * Uncontrolled coagulopathy * Taking antiplatelet drug or anticoagulant
References
Publications (12)
- RESULTSharma P. Barrett Esophagus: A Review. JAMA. 2022 Aug 16;328(7):663-671. doi: 10.1001/jama.2022.13298. PMID 35972481
- RESULTRichter JE, Rubenstein JH. Presentation and Epidemiology of Gastroesophageal Reflux Disease. Gastroenterology. 2018 Jan;154(2):267-276. doi: 10.1053/j.gastro.2017.07.045. Epub 2017 Aug 3. PMID 28780072
- RESULTShiota S, Singh S, Anshasi A, El-Serag HB. Prevalence of Barrett's Esophagus in Asian Countries: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1907-18. doi: 10.1016/j.cgh.2015.07.050. Epub 2015 Aug 7. PMID 26260107
- RESULTDesai TK, Krishnan K, Samala N, Singh J, Cluley J, Perla S, Howden CW. The incidence of oesophageal adenocarcinoma in non-dysplastic Barrett's oesophagus: a meta-analysis. Gut. 2012 Jul;61(7):970-6. doi: 10.1136/gutjnl-2011-300730. Epub 2011 Oct 13. PMID 21997553
- RESULTSingh S, Manickam P, Amin AV, Samala N, Schouten LJ, Iyer PG, Desai TK. Incidence of esophageal adenocarcinoma in Barrett's esophagus with low-grade dysplasia: a systematic review and meta-analysis. Gastrointest Endosc. 2014 Jun;79(6):897-909.e4; quiz 983.e1, 983.e3. doi: 10.1016/j.gie.2014.01.009. Epub 2014 Feb 17. PMID 24556051
- RESULTRastogi A, Puli S, El-Serag HB, Bansal A, Wani S, Sharma P. Incidence of esophageal adenocarcinoma in patients with Barrett's esophagus and high-grade dysplasia: a meta-analysis. Gastrointest Endosc. 2008 Mar;67(3):394-8. doi: 10.1016/j.gie.2007.07.019. Epub 2007 Nov 28. PMID 18045592
- RESULTHamade N, Vennelaganti S, Parasa S, Vennalaganti P, Gaddam S, Spaander MCW, van Olphen SH, Thota PN, Kennedy KF, Bruno MJ, Vargo JJ, Mathur S, Cash BD, Sampliner R, Gupta N, Falk GW, Bansal A, Young PE, Lieberman DA, Sharma P. Lower Annual Rate of Progression of Short-Segment vs Long-Segment Barrett's Esophagus to Esophageal Adenocarcinoma. Clin Gastroenterol Hepatol. 2019 Apr;17(5):864-868. doi: 10.1016/j.cgh.2018.07.008. Epub 2018 Aug 8.