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

Observation of Major Duodenal Papilla (MDP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219619
• Other study ID #: KY20170517-3
• Status: Completed
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: July 20, 2018

Study information

• Verified date: October 2019
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Observation of Major Duodenal Papilla (MDP)

Intervention

Device:
• Cap-EGD
Undergoing cap-assisted endoscopy
• Duo
Undergoing side-viewing duodenoscope

Locations

Country	Name	City	State
China	Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University	Chongqing
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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