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

Not Applicable

Completed

• Conditions: Observation of Major Duodenal Papilla (MDP)
• Interventions: Device: Cap-EGD; Device: Duo

• Registration Number: NCT03219619
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-17
• Study Start: 2018-07-20
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cap group: Cap-EGD	Cap-EGD	Undergoing cap-assisted esophagogastroduodenoscopy
Duo group: Duo	Duo	Undergoing side-viewing duodenoscope

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall endoscopic findings	5 minutes after intubation of the esophagus	All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, gastric cancer, gastric ulcer, duodenal ulcer, etc)
Endoscopic findings in descending duodenum	5 minutes after intubation of the esophagus	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)
MDP examination time	5 minutes after intubation of the esophagus	The times taken for the examination of the MDP (after passing the pylorus until examination of MDP)
MDP examination score	5 minutes after intubation of the esophagus	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

Trial Locations

Locations (2)

Endoscopic center, Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China

Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China