Completed

NCT Number: NCT03219619

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

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.

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Key information

Conditions

Observation of Major Duodenal Papilla (MDP)

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cap-EGD

Device

Undergoing cap-assisted endoscopy

Duo

Device

Undergoing side-viewing duodenoscope

Primary outcomes

Rate of complete examination of MDP

Time frame: 5 minutes after intubation of the esophagus

Complete examination is defined by visualization of both proximal and distal ends with orifice of papilla

Secondary outcomes

Endoscopic findings in descending duodenum

Time frame: 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)
Overall endoscopic findings

Time frame: 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)
MDP examination time

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jul 17, 2017
Registry last updated: Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.