Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla

Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla: a Randomized Non-inferiority Trial

Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden standard. However, side-viewing duodenoscope is not available in some endoscopic centers. Cap-assisted esophagogastroduodenoscopy (Ca-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for the observation of MDP. A recent study showed that complete examination of MDP could be achieved in 97% of patients. The investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of MDP.

Study Overview

• Status: Completed
• Conditions: Observation of Major Duodenal Papilla (MDP)
• Intervention / Treatment: Device: Cap-EGD; Device: Duo

Detailed Description

Interim analyses were planned to be performed by the data and safety monitoring board after data collection has been completed for 50% of the enrollment.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400010
    • Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Endoscopic center, Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years and < 70 years
• Patients with native MDP who underwent ERCP

Exclusion Criteria:

• Prior surgery in upper GI tract
• Prior history of endoscopic sphincterotomy
• Prior history of MDP treatment
• Known or suspected obstruction of upper GI tract
• Patients in poor condition who may not be suitable for Ca-EGD or duodenoscope
• Pregnancy or lactic women
• Inability to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cap group: Cap-EGD; Undergoing cap-assisted esophagogastroduodenoscopy	Device: Cap-EGD; Undergoing cap-assisted endoscopy
Active Comparator: Duo group: Duo; Undergoing side-viewing duodenoscope	Device: Duo; Undergoing side-viewing duodenoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complete examination of MDP	Complete examination is defined by visualization of both proximal and distal ends with orifice of papilla	5 minutes after intubation of the esophagus

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic findings in descending duodenum	All pathological findings which are seen in descending duodenum should be reported (e.g. ampullary adenoma, peripapillary diverticulum, ampullary carcinoma, inflammatory change of papilla, etc)	5 minutes after intubation of the esophagus
Overall endoscopic findings	All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, gastric cancer, gastric ulcer, duodenal ulcer, etc)	5 minutes after intubation of the esophagus
MDP examination time	The times taken for the examination of the MDP (after passing the pylorus until examination of MDP)	5 minutes after intubation of the esophagus
MDP examination score	Score 3 when proximal end, distal end and orifice were visualized; Score 2 when either proximal or distal end with orifice were visualized; Score 1 when either proximal or distal end without orifice was visualized; Score 0 when the MDP could not be localized	5 minutes after intubation of the esophagus

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General Publications

• Shi X, Luo H, Ning B, Wang X, Tao Q, Liang S, Zhang R, Chen J, Luo B, Yao S, Pan Y, Guo X, Fan D. Effect of cap-assisted esophagogastroduodenoscopy on examination of the major duodenal papilla: a noninferior, randomized controlled trial. Endoscopy. 2019 May;51(5):427-435. doi: 10.1055/a-0767-6529. Epub 2019 Jan 8.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Actual): July 20, 2018
• Study Completion (Actual): July 20, 2018

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: KY20170517-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No