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Periampullary Lesions Via ERCP in Assuit University Hospital

Periampullary Lesions Via ERCP in Assuit University Hospital

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03185390
Enrollment
150
Registered
2017-06-14
Start date
2017-06-15
Completion date
2019-05-01
Last updated
2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ERCP

Keywords

periampullary lesions

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.

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.

Interventions

PROCEDUREERCP guided biopsy or brush cytology

ERCP guided biopsy or brush cytology

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
percentage of different types of periampullary massesand efficacy of ERCP guided biopsy calculating the number of cases correctly diagnosed by ERCP or guided biopsyone year

Secondary

MeasureTime frame
number of cases addmited in Assiut University Hospital with differrent types of periampullary mass diagnosed correctly by the help of ERCPone year

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026