The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

NCT05818072 | Recruiting

• 1 other identifier: EDAHS-111031
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Barrett's Esophagus; Intestinal Metaplasia

Keywords

Barrett's Esophagus; Columnar-lined esophagus; Intestinal metaplasia

Outcome Measures

Primary Outcomes (1)

• The yield rate of intestinal metaplasia

  Defined as the proportion of histologic confirmation of goblet cells

  Up to 7 days histologic confirmation

Secondary Outcomes (3)

• The yield rate of dysplasia

  Up to 7 days histologic confirmation

• Adverse events

  From the date of procedure until any events, assessed up to 2 weeks

• Procedure time

  From forcep insertion to biopsy complete, assessed up to 1 minutes

Study Arms (3)

One biopsy

EXPERIMENTAL

Obtain one biopsy specimen at the proximal part of the the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus

Procedure: One biopsy; Device: Endoscopy

Three biopsy

ACTIVE COMPARATOR

Obtain three biopsy specimens at the proximal, middle and distal part of the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus

Procedure: Three biopsy; Device: Endoscopy

Seattle protocol

SHAM COMPARATOR

Obtain 4-quadrant biopsy specimens at intervals of every 1 to 2 cm throughout the the columnar-lined esophagus for patients with suspected Barrett's Esophagus

Procedure: Seattle protocol; Device: Endoscopy

Interventions

One biopsy PROCEDURE

To do one biopsy at the proximal part of the longest columnar-lined esophagus.

One biopsy

Three biopsy PROCEDURE

To do three biopsy at the proximal, middle and distal part of the longest columnar-lined esophagus.

Three biopsy

Seattle protocol PROCEDURE

To do 4-quadrant biopsy every 1-2 cm at the esophagogastric junction. Seattle protocol has been considered as the gold standard biopsy protocol for patients with suspected Barrett's Esophagus.

Seattle protocol

Endoscopy DEVICE

The participants will receive meticulous endoscopic examination with narrow-band imaging.

One biopsy; Seattle protocol; Three biopsy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with columnar-lined esophagus

You may not qualify if:

• 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

Sponsors & Collaborators

• E-DA Hospital: lead

Study Sites (1)

E-DA Hospital

Kaohsiung City, 82445, Taiwan

RECRUITING

Related Publications (12)

• Sharma P. Barrett Esophagus: A Review. JAMA. 2022 Aug 16;328(7):663-671. doi: 10.1001/jama.2022.13298.

  PMID: 35972481 RESULT

• Richter 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 RESULT

• Shiota 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 RESULT

• Desai 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 RESULT

• Singh 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 RESULT

• Rastogi 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 RESULT

• Hamade 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.

  PMID: 30012433 RESULT

• Shaheen NJ, Falk GW, Iyer PG, Souza RF, Yadlapati RH, Sauer BG, Wani S. Diagnosis and Management of Barrett's Esophagus: An Updated ACG Guideline. Am J Gastroenterol. 2022 Apr 1;117(4):559-587. doi: 10.14309/ajg.0000000000001680.

  PMID: 35354777 RESULT

• Fitzgerald RC, di Pietro M, Ragunath K, Ang Y, Kang JY, Watson P, Trudgill N, Patel P, Kaye PV, Sanders S, O'Donovan M, Bird-Lieberman E, Bhandari P, Jankowski JA, Attwood S, Parsons SL, Loft D, Lagergren J, Moayyedi P, Lyratzopoulos G, de Caestecker J; British Society of Gastroenterology. British Society of Gastroenterology guidelines on the diagnosis and management of Barrett's oesophagus. Gut. 2014 Jan;63(1):7-42. doi: 10.1136/gutjnl-2013-305372. Epub 2013 Oct 28.

  PMID: 24165758 RESULT

• Abrams JA, Kapel RC, Lindberg GM, Saboorian MH, Genta RM, Neugut AI, Lightdale CJ. Adherence to biopsy guidelines for Barrett's esophagus surveillance in the community setting in the United States. Clin Gastroenterol Hepatol. 2009 Jul;7(7):736-42; quiz 710. doi: 10.1016/j.cgh.2008.12.027. Epub 2009 Jan 13.

  PMID: 19268726 RESULT

• Ronkainen J, Aro P, Storskrubb T, Johansson SE, Lind T, Bolling-Sternevald E, Vieth M, Stolte M, Talley NJ, Agreus L. Prevalence of Barrett's esophagus in the general population: an endoscopic study. Gastroenterology. 2005 Dec;129(6):1825-31. doi: 10.1053/j.gastro.2005.08.053.

  PMID: 16344051 RESULT

• Tseng PH, Lee YC, Chiu HM, Huang SP, Liao WC, Chen CC, Wang HP, Wu MS, Lin JT. Prevalence and clinical characteristics of Barrett's esophagus in a Chinese general population. J Clin Gastroenterol. 2008 Nov-Dec;42(10):1074-9. doi: 10.1097/MCG.0b013e31809e7126.

  PMID: 18360296 RESULT

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Ying-Nan Tsai, M.D

CONTACT

886-7-6150011; littlepig9933@gmail.com

Wen-Lun Wang, Ph.D

CONTACT

886-7-6150011; warrengodr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: April 18, 2023
• Study Start: March 13, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)