Periampullary Lesions Via ERCP in Assuit University Hospital

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03185390
Collaborator
(none)
150
1
1
22.5
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ERCP guided biopsy or brush cytology
N/A

Detailed Description

Periampullary lesion is defined as lesion located in 2CM around the ampulla of Vater. Periampullary lesions, identified during endoscopic retrograde cholangiopancreatography (ERCP), duodenoscopy or endoscopic ultrasonography (EUS) often present a diagnostic dilemma. Although some of these lesions represent a benign lesion, they also occur in case of malignancy. Therefore, management of periampullary lesions widely varies from observation for low-grade dysplasia to pancreaticoduodenectomy in case of invasive carcinoma. Unfortunately, endoscopic biopsies are by definition superficial and, therefore, the risk of a sample errors exists. On the other hand the similarity in presentation and the difficulty in accurate location of the origin of these lesions often leads to a diagnostic challenge. ERCP in addition to its diagnostic value it allows therapeutic procedures, such as sphincterotomy, stenting, and nasobiliary drainage. It permits sampling of pancreatic juice, bile, and brush or grasp biopsy, but endoscopic biopsies are by definition superficial and, therefore, the risk of a sample errors exists .

ERCP is an invasive procedure that requires an expert endoscopist/radiologist and a cooperative patient.

Very small tumors (< 1 cm) can be missed. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Periampullary Lesions Via ERCP in Assuit University Hospital
Actual Study Start Date :
Jun 15, 2017
Actual Primary Completion Date :
Jun 15, 2018
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: ERCP guided biopsy or brush cytology

ERCP guided biopsy or brush cytology

Procedure: ERCP guided biopsy or brush cytology
ERCP guided biopsy or brush cytology

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. number of cases addmited in Assiut University Hospital with differrent types of periampullary mass diagnosed correctly by the help of ERCP [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All cases admitted in Assuit university hospital with periampullary lesions detected by ERCP within the period of the study.
Exclusion Criteria:
  • Cases diagnosed to have periampullary lesion and managed without ERCP

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut Univesity Hospital Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: morsy m morsy, professor, prof

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
emad mamdouh, Principle invvestigat, Assiut University
ClinicalTrials.gov Identifier:
NCT03185390
Other Study ID Numbers:
  • 17100192
First Posted:
Jun 14, 2017
Last Update Posted:
May 11, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by emad mamdouh, Principle invvestigat, Assiut University

Study Results

No Results Posted as of May 11, 2020