The Use of a OCT Probe in Assessment of Endoscopic and Surgical Resection Specimen of Gastrointestinal Tract
Primary Purpose
Gastrointestinal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Optical Coherence Tomography Probe
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Neoplasms focused on measuring Gastrointestinal neoplasm, Optical coherence tomography
Eligibility Criteria
Inclusion Criteria:
- Patients with esophageal, gastric or colonic cancer undergoing elective surgical resection
- Patients with early esophageal, gastric or colonic neoplasia undergoing endoscopic resection (Endoscopic submucosal dissection)
Exclusion Criteria:
- Refusal to participate
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OCT probe
Arm Description
The examination of gastrointestinal tract resected specimen with the use of the OCT probe
Outcomes
Primary Outcome Measures
Visualisation of gastrointestinal tract
Visualisation of different layers of gastrointestinal tract. Ability to differentiate mucosa and submucosa and muscular propria layer. (Yes or No).
Secondary Outcome Measures
Ability to asses depth of invasion of resected GI early tumor
Ability to assess depth of invasion of resected GI early tumor
Full Information
NCT ID
NCT04670718
First Posted
December 11, 2020
Last Updated
July 27, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04670718
Brief Title
The Use of a OCT Probe in Assessment of Endoscopic and Surgical Resection Specimen of Gastrointestinal Tract
Official Title
The Use of a Novel Optical Coherence Tomography (OCT) Probe in Assessment of Endoscopic and Surgical Resection Specimen of Gastrointestinal Tract
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study aiming to investigate the ability of a novel Optical Coherence Tomography (OCT) probe in assessing the different layers of the gastrointestinal tract and the depth of invasion of early neoplasia, utilising surgically and endoscopically resected specimens
Detailed Description
Endoscopic treatment of early neoplasia in the gastrointestinal tract has been established as the standard therapy in the past decade. Various endoscopic resection techniques have been developed, such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), to ensure complete removal of such lesions and avoid recurrence. Successful endoscopic resection of early gastrointestinal (GI) neoplasia relies on accurate pre-procedural prediction of the margin and depth of invasion of the corresponding lesions. Generally, GI neoplasia (even carcinoma) confined to the mucosa layer could be safely removed endoscopically with margin negative resection and minimal chance of lymph node involvement.
Image-enhanced endoscopy or endoscopic ultrasonography has been used as the modality of pre-resection assessment on the depth of invasion. Chromoendoscopy and digital enhancement such as magnifying Narrow Band Imaging (NBI) focus on characterization of the surface morphology and the vascular structures and predict the depth of invasion instead of direct depth measurement. Endoscopic ultrasonography allows good visualization of the different layers of GI tract, but the ability to differentiate early mucosal (T1a) or submucosal invasive (T1b) cancer remains limited owing to its low resolution (>100um). A small proportion of patients subjected for endoscopic resection had invasive cancer not curable by endoscopic means and require additional surgery afterwards. There is thus a potential role for further refinement of imaging technique to allow better prediction of tumor depth in early GI neoplasia.
Optical coherence tomography (OCT) is a novel high spatial-resolution, cross-sectional imaging technique that allows visualization of biological tissue at higher resolution (~10um). It has been used routinely in the field of ophthalmology for retinal assessment. Earlier studies have also confirmed the potential application in the gastrointestinal tract with a probe-based design to be placed within an endoscopy.
The Department of Mechanical and Automation Engineering from the Chinese University of Hong Kong have recently designed a novel OCT probe that could be placed within the working channel of an endoscope. In-vitro experiment with porcine intestinal model demonstrated its ability to provide high-resolution images with visualization of different layers of the GI tract. The investigators therefore design this pilot study to assess the application of the OCT probe in human resected tissue specimen to assess the ability in determining different layers of GI tract and depth of invasion of GI tumors.
The current pilot study is designed aiming to assess the ability of the novel OCT probe in visualization of the layers of the human GI tract and depth of invasion of GI neoplasia in resected surgical and endoscopic specimens. There would be two parts of the study:
To visualize normal gastrointestinal tract in a resected surgical specimen of esophageal, stomach, small bowel and colonic tissue.
To assess the depth of invasion of the neoplastic tissue in surgical specimens as well as endoscopic (ESD) specimens
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms
Keywords
Gastrointestinal neoplasm, Optical coherence tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCT probe
Arm Type
Experimental
Arm Description
The examination of gastrointestinal tract resected specimen with the use of the OCT probe
Intervention Type
Device
Intervention Name(s)
Optical Coherence Tomography Probe
Intervention Description
Use of OCT probe for examination of gastrointestinal tract
Primary Outcome Measure Information:
Title
Visualisation of gastrointestinal tract
Description
Visualisation of different layers of gastrointestinal tract. Ability to differentiate mucosa and submucosa and muscular propria layer. (Yes or No).
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Ability to asses depth of invasion of resected GI early tumor
Description
Ability to assess depth of invasion of resected GI early tumor
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with esophageal, gastric or colonic cancer undergoing elective surgical resection
Patients with early esophageal, gastric or colonic neoplasia undergoing endoscopic resection (Endoscopic submucosal dissection)
Exclusion Criteria:
Refusal to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hon Chi Yip, MBChB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
The Use of a OCT Probe in Assessment of Endoscopic and Surgical Resection Specimen of Gastrointestinal Tract
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