Back to resultsThe Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
Primary Purpose
Ampulla of Vater Intestinal-Type Adenoma
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Cap
Sponsored by
About this trial
This is an interventional diagnostic trial for Ampulla of Vater Intestinal-Type Adenoma focused on measuring Endoscopy, Ampulla of Vater, Duodenoscopy
Eligibility Criteria
Inclusion Criteria:
- Cap-assisted endoscopy
- Referral to endoscopic examination of ampulla of Vater
Exclusion Criteria:
- Patients with surgically modified anatomy.
- Obstruction of the upper gastrointestinal tract.
- Contra-indication for endoscopy.
- Absence of informed consent.
Sites / Locations
- Barretos Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cap-assisted endoscopy
Arm Description
forward-viewing endoscope with a Cap attached at the tip
Outcomes
Primary Outcome Measures
Visualization rates of the ampulla of Vater
Secondary Outcome Measures
Rates of complications for both groups.
Additional time required for Cap-assisted endoscopy
Need for additional sedation required for the Cap-assisted endoscopy.
Full Information
NCT ID
NCT02867826
First Posted
August 8, 2016
Last Updated
August 17, 2016
Sponsor
Barretos Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02867826
Brief Title
The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
Official Title
The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barretos Cancer Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.
Detailed Description
The complete visualization of the ampulla of Vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. There are limited data in the relevant literature regarding the effectiveness of the Cap assisted forward viewing endoscope for accurate evaluation of the ampulla de Vater. Therefore, the aim of this study is to compare the visualization rates of the ampulla of Vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ampulla of Vater Intestinal-Type Adenoma
Keywords
Endoscopy, Ampulla of Vater, Duodenoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cap-assisted endoscopy
Arm Type
Experimental
Arm Description
forward-viewing endoscope with a Cap attached at the tip
Intervention Type
Device
Intervention Name(s)
Cap
Intervention Description
Cap-assisted endoscopy
Primary Outcome Measure Information:
Title
Visualization rates of the ampulla of Vater
Time Frame
Up to 30 minutes during gastrointestinal endoscopy
Secondary Outcome Measure Information:
Title
Rates of complications for both groups.
Time Frame
Up to 3 hours after upper endoscopy
Title
Additional time required for Cap-assisted endoscopy
Time Frame
Up to 30 minutes during upper endoscopy
Title
Need for additional sedation required for the Cap-assisted endoscopy.
Time Frame
Up to 30 minutes during upper endoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Cap-assisted endoscopy
Referral to endoscopic examination of ampulla of Vater
Exclusion Criteria:
Patients with surgically modified anatomy.
Obstruction of the upper gastrointestinal tract.
Contra-indication for endoscopy.
Absence of informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise P Guimarães, MD, PhD
Phone
+551733216600
Email
guimaraes.dp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise P Guimarães, MD, PhD
Organizational Affiliation
Barretos Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barretos Cancer Hospital
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784400
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise P Guimarães, MD, PhD
Phone
+55 17 33216600
Ext
6777
Email
guimaraes.dp@gmail.com
First Name & Middle Initial & Last Name & Degree
Denise P Guimarães, MD, PhD
First Name & Middle Initial & Last Name & Degree
Leonardo C Silva, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32646369
Citation
Silva LC, Arruda RM, Botelho PFR, Taveira LN, Giardina KM, de Oliveira MA, Dias J, Oliveira CZ, Fava G, Guimaraes DP. Cap-assisted endoscopy increases ampulla of Vater visualization in high-risk patients. BMC Gastroenterol. 2020 Jul 9;20(1):214. doi: 10.1186/s12876-020-01361-5.
Results Reference
derived
Learn more about this trial
The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
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