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

N/ACompletedNCT03219619

Air Force Military Medical University, China171 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

171

Conditions

Observation of Major Duodenal Papilla (MDP)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Rate of complete examination of MDP

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