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

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



Sponsors


Source

Fourth Military Medical University

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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. We hypothesize
that Ca-EGD is non-inferior to duodenoscope for the observation of MDP.

Overall Status

Not yet recruiting

Start Date

2017-07-13

Completion Date

2018-01-20

Primary Completion Date

2018-01-20

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Rate of complete examination of MDP
5 minutes after intubation of the esophagus

Secondary Outcome

Measure

Time Frame

Endoscopic findings in descending duodenum
5 minutes after intubation of the esophagus
Overall endoscopic findings
5 minutes after intubation of the esophagus
MDP examination time
5 minutes after intubation of the esophagus
MDP examination score
5 minutes after intubation of the esophagus

Enrollment

150

Condition


Intervention

Intervention Type

Device

Intervention Name


Description

Undergoing cap-assisted endoscopy

Arm Group Label

Cap group: Cap-EGD


Intervention Type

Device

Intervention Name

 Duo

Description

Undergoing side-viewing duodenoscope

Arm Group Label

Duo group: Duo



Eligibility

Criteria

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

Gender

All

Minimum Age

18 Years

Maximum Age

70 Years

Healthy Volunteers

No


Location

Facility

Status

Contact

Investigator

Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an Shaanxi 710032 China
Not yet recruiting
Last Name: Yanglin Pan, M.D.
Phone: 86-29-84771536
Email: [email protected]
Last Name: Yanglin Pan, M.D.
Role: Principal Investigator
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing 400010 China
Not yet recruiting
Last Name: Bo Ning, M.D.
Phone: +8613996476336
Email: [email protected]
Last Name: Bo Ning, M.D.
Role: Principal Investigator

Location Countries

Country

China


Verification Date

2017-07-01

Lastchanged Date

2017-07-13

Firstreceived Date

2017-07-13

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Fourth Military Medical University

Investigator Full Name

Yanglin Pan

Investigator Title

Associate Professor


Has Expanded Access

No

Number Of Arms

2

Arm Group

Arm Group Label

Cap group: Cap-EGD

Arm Group Type

Experimental

Description

Undergoing cap-assisted esophagogastroduodenoscopy


Arm Group Label

Duo group: Duo

Arm Group Type

Active Comparator

Description

Undergoing side-viewing duodenoscope



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Diagnostic

Masking

Participant



ClinicalTrials.gov processed this data on July 17, 2017

Conditions

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Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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