Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia

NCT01688687 | Completed DMC

• 1 other identifier: MD-2012-01
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are limited data exploring the application of pCLE to gastric lesions, and this is the first study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the final specimens obtained from endoscopic resection as a reference standard. The aims of this study were (1) the accuracy of pCLE compared to conventional forceps biopsy using histopathology results following endoscopic resection as a reference, and (2) comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis, and off-line interobserver agreement.

Conditions

Early Gastric Cancer; Gastric Dysplasia

Outcome Measures

Primary Outcomes (1)

• The accuracy of pCLE compared to conventional forceps biopsy

  The accuracy of pCLE compared to conventional forceps biopsy was assessed using histopathology results following endoscopic resection as a reference

  in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.

Secondary Outcomes (2)

• Comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis.

  1-3 months after endoscopic resection and final histopathological analysis

• Off-line pCLE interobserver agreement

  1-3 months after endoscopic resection and final histopathological analysis

Study Arms (1)

Superficial gastric neoplasia

Patients with superficial gastric neoplasia on diagnostic endoscopy, recieved both conventional endoscopic forcpes biopsies and pCLE. All patients were subject to endoscopic resection of the lesion.

Procedure: Endoscopic submucosal dissection

Interventions

Endoscopic submucosal dissection PROCEDURE

Superficial gastric neoplasia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients referred to a tertiary medical center for endoscopic resection of gastric superficial lesions.

You may qualify if:

• Patients with biospy proven superficial gastric neoplasia, suitable for endoscopic resection.

You may not qualify if:

• Patients with uncorrectable coagulopathy,
• liver cirrhosis,
• acute gastrointestinal bleeding,
• pregnancy,
• breast feeding,
• documented allergy to fluorescein,
• patients with lesions that were deemed unsuitable for endoscopic resection, and
• patients without documented conventional biopsy results.

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang University Seoul Hospital

Seoul, 140-743, South Korea

Location

Related Publications (5)

• Wallace M, Lauwers GY, Chen Y, Dekker E, Fockens P, Sharma P, Meining A. Miami classification for probe-based confocal laser endomicroscopy. Endoscopy. 2011 Oct;43(10):882-91. doi: 10.1055/s-0030-1256632. Epub 2011 Aug 4.

  PMID: 21818734 RESULT

• Jeon SR, Cho WY, Jin SY, Cheon YK, Choi SR, Cho JY. Optical biopsies by confocal endomicroscopy prevent additive endoscopic biopsies before endoscopic submucosal dissection in gastric epithelial neoplasias: a prospective, comparative study. Gastrointest Endosc. 2011 Oct;74(4):772-80. doi: 10.1016/j.gie.2011.05.005. Epub 2011 Jul 29.

  PMID: 21802680 RESULT

• Shahid MW, Buchner AM, Raimondo M, Woodward TA, Krishna M, Wallace MB. Accuracy of real-time vs. blinded offline diagnosis of neoplastic colorectal polyps using probe-based confocal laser endomicroscopy: a pilot study. Endoscopy. 2012 Apr;44(4):343-8. doi: 10.1055/s-0031-1291589. Epub 2012 Mar 1.

  PMID: 22382851 RESULT

• Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.

  PMID: 22749368 RESULT

• Kuiper T, Kiesslich R, Ponsioen C, Fockens P, Dekker E. The learning curve, accuracy, and interobserver agreement of endoscope-based confocal laser endomicroscopy for the differentiation of colorectal lesions. Gastrointest Endosc. 2012 Jun;75(6):1211-7. doi: 10.1016/j.gie.2012.01.040. Epub 2012 Mar 28.

  PMID: 22459661 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endscopic resection specimens of gastric neoplasia. Speciments were obtained either by endoscopic mucosal resection or endoscopic submucosal dissection.

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 20, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2012
• Last Updated: September 20, 2012

Record last verified: 2012-09

Locations

KR (1)