Epidermoid Cancer Development in Esophageal Achalasia

NCT ID: NCT03546998

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

681 participants

Study Classification

OBSERVATIONAL

Study Start Date

1973-01-01

Study Completion Date

2025-12-31

Brief Summary

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Esophageal achalasia is a precancerous condition for epidermoid carcinoma; incidence and risk factors for cancer development are not defined. Incidence and risk factors for epidermoid carcinoma development in achalasia patients were investigated.

Detailed Description

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In order to define incidence and risk factors for epidermoid carcinoma 681 patients affected by esophageal achalasia observed since 1973 were followed up with no time limits according to a prospective follow-up protocol. The local institutional review board approved using the database from the division of thoracic surgery for research purposes. Clinical, radiological and endoscopic data of achalasia patients were collected and analyzed.

Conditions

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Achalasia Epidermoid Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Clinical instrumental examinations

Achalasia patients were periodically submitted to clinical assessment, barium swallow (esophageal diameter and residual barium column were measured), endoscopy. Mucosal esophageal biopsies were taken in order to diagnose dysplasia or epidermoid carcinoma.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* diagnosis of primary esophageal achalasia achieved by means of radiology, endoscopy and manometry

Exclusion Criteria

* pseudoachalasia
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sandro Mattioli

OTHER

Sponsor Role lead

Responsible Party

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Sandro Mattioli

Prof. Sandro Mattioli

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sandro Mattioli, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical and Surgical Sciences-Alma Mater Studiorum-Università di Bologna

Locations

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Division of Thoracic Surgery Maria Cecilia Hospital

Cotignola, RA, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Sandro Mattioli, MD

Role: CONTACT

0039 0512144643

Marisaluisa Lugaresi, MD

Role: CONTACT

3356843779

Facility Contacts

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Sandro Mattioli, MD

Role: primary

+39 051-6364643

Marialuisa Lugaresi, MD

Role: backup

0039 0512144643

Other Identifiers

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Epidermoid cancer in achalasia

Identifier Type: -

Identifier Source: org_study_id

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