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

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Observation of Major Duodenal Papilla (MDP)

Treatments: Device: Duo; Device: Cap-EGD

Study type: Interventional

Funder types: Other

Identifiers

NCT03219619

KY20170517-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

171 participants in 2 patient groups

Cap group: Cap-EGD

Experimental group

Description:

Undergoing cap-assisted esophagogastroduodenoscopy

Treatment:

Device: Cap-EGD

Duo group: Duo

Active Comparator group

Description:

Undergoing side-viewing duodenoscope

Treatment:

Device: Duo