Epidermoid Cancer Development in Esophageal Achalasia
Incidence and Risk Factors for Development of Epidermoid Carcinoma in Esophageal Achalasia
1 other identifier
observational
681
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 1973
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1973
CompletedFirst Submitted
Initial submission to the registry
April 27, 2018
CompletedFirst Posted
Study publicly available on registry
June 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 6, 2018
May 1, 2018
53 years
April 27, 2018
May 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection of epidermoid carcinoma of the esophagus
Detection of epidermoid carcinoma of the esophagus by means of upper GI endoscopy
1 year
Secondary Outcomes (1)
Result of achalasia treatment by investigating dysphagia and gastro-esophageal reflux
1 year
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- diagnosis of primary esophageal achalasia achieved by means of radiology, endoscopy and manometry
You may not qualify if:
- pseudoachalasia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandro Mattiolilead
Study Sites (1)
Division of Thoracic Surgery Maria Cecilia Hospital
Cotignola, RA, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandro Mattioli, MD
Department of Medical and Surgical Sciences-Alma Mater Studiorum-Università di Bologna
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 25 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Sandro Mattioli
Study Record Dates
First Submitted
April 27, 2018
First Posted
June 6, 2018
Study Start
January 1, 1973
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
June 6, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share