Epidermoid Cancer Development in Esophageal Achalasia

May 23, 2018 updated by: Sandro Mattioli

Incidence and Risk Factors for Development of Epidermoid Carcinoma in Esophageal Achalasia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

681

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • RA
      • Cotignola, RA, Italy
        • Recruiting
        • Division of Thoracic Surgery Maria Cecilia Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Valentina Tassi, MD
        • Sub-Investigator:
          • Marialuisa Lugaresi, MD
        • Sub-Investigator:
          • Niccolò Daddi, MD
        • Sub-Investigator:
          • Benedetta Mattioli, MD
        • Sub-Investigator:
          • Francesca Fortunato, PhD
        • Sub-Investigator:
          • Rocco Maurizio Zagari, MD
        • Sub-Investigator:
          • Francesco Bassi, MD
        • Sub-Investigator:
          • Vladimiro Pilotti, MD
        • Principal Investigator:
          • Sandro Mattioli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

681 patients admitted at the division of Clinica Chirurgica II of the University of Bologna from 1973 and undergone surgery, pneumatic dilations or medical therapy for esophageal achalasia.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pseudoachalasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of epidermoid carcinoma of the esophagus
Time Frame: 1 year
Detection of epidermoid carcinoma of the esophagus by means of upper GI endoscopy
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Result of achalasia treatment by investigating dysphagia and gastro-esophageal reflux
Time Frame: 1 year
Result of achalasia treatment assessed by means of semiquantitative grading scales of dysphagia and gastro-esophageal reflux
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandro Mattioli

Investigators

  • Principal Investigator: Sandro Mattioli, MD, Department of Medical and Surgical Sciences-Alma Mater Studiorum-Università di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1973

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 27, 2018

First Submitted That Met QC Criteria

May 23, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Epidermoid cancer in achalasia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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