Clinical Trial: The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
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 Summary: 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.
Sponsor: Barretos Cancer Hospital
Current Primary Outcome: Visualization rates of the ampulla of Vater [ Time Frame: Up to 30 minutes during gastrointestinal endoscopy ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Rates of complications for both groups. [ Time Frame: Up to 3 hours after upper endoscopy ]
- Additional time required for Cap-assisted endoscopy [ Time Frame: Up to 30 minutes during upper endoscopy ]
- Need for additional sedation required for the Cap-assisted endoscopy. [ Time Frame: Up to 30 minutes during upper endoscopy ]
Original Secondary Outcome: Same as current
Information By: Barretos Cancer Hospital
Dates:
Date Received: August 8, 2016
Date Started: August 2016
Date Completion: December 2017
Last Updated: August 17, 2016
Last Verified: August 2016
