Periampullary Lesions Via ERCP in Assuit University Hospital

NCT03185390 | Completed DMC

• 1 other identifier: 17100192
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

A periampullary lesion may be begin as duodenal adenoma, ampullary adenoma, gall stone pregnant ampulla, Stricture, or periampullary lipoma, or malignant as pancreatic ductal adenocarcinoma, distal CBD cholangiocarcinoma, ampullary carcinoma and periampullary duodenal adenocarcinoma, pancreatic carcinoma. The aim of the study is to detect incidence of different types of periampullary lesions detected by ERCP in Assuit University Hospital and the role of ERCP in early detection, diagnosis and management and diagnostic accuracy and sensitivity of biopsy and brush cytology taken by ERCP in a period of 1 years starting from June 2017 to June 2018.

Conditions

ERCP

Keywords

periampullary lesions

Outcome Measures

Primary Outcomes (1)

• percentage of different types of periampullary massesand efficacy of ERCP guided biopsy calculating the number of cases correctly diagnosed by ERCP or guided biopsy

  one year

Secondary Outcomes (1)

• number of cases addmited in Assiut University Hospital with differrent types of periampullary mass diagnosed correctly by the help of ERCP

  one year

Study Arms (1)

ERCP guided biopsy or brush cytology

OTHER

ERCP guided biopsy or brush cytology

Procedure: ERCP guided biopsy or brush cytology

Interventions

ERCP guided biopsy or brush cytology PROCEDURE

ERCP guided biopsy or brush cytology

ERCP guided biopsy or brush cytology

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All cases admitted in Assuit university hospital with periampullary lesions detected by ERCP within the period of the study.

You may not qualify if:

• Cases diagnosed to have periampullary lesion and managed without ERCP

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Univesity Hospital

Asyut, Egypt

Location

Study Officials

• morsy m morsy, professor

  prof

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle invvestigat

Model Details: All cases admitted in Assuit university hospital with periampullary lesions detected by ERCP with ERCP guided biopsy or brush cytology within the period of the study.

Study Record Dates

• First Submitted: June 3, 2017
• First Posted: June 14, 2017
• Study Start: June 15, 2017
• Primary Completion: June 15, 2018
• Study Completion: May 1, 2019
• Last Updated: May 11, 2020

Record last verified: 2020-05

Locations

EG (1)