Epidermoid Cancer Development in Esophageal Achalasia

Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03546998
• Other study ID #: Epidermoid cancer in achalasia
• Status: Recruiting
• Start date: January 1, 1973
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2018
• Source: University of Bologna
• Contact: Sandro Mattioli, MD
• Phone: 0039 0512144643
• Email: sandro.mattioli[@]unibo.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 681
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pseudoachalasia

Related Conditions & MeSH terms

• Achalasia
• Carcinoma
• Carcinoma, Squamous Cell
• Epidermoid Carcinoma
• Esophageal Achalasia

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Italy	Division of Thoracic Surgery Maria Cecilia Hospital	Cotignola	RA

Sponsors (1)

Lead Sponsor	Collaborator
Sandro Mattioli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of epidermoid carcinoma of the esophagus	Detection of epidermoid carcinoma of the esophagus by means of upper GI endoscopy	1 year
Secondary	Result of achalasia treatment by investigating dysphagia and gastro-esophageal reflux	Result of achalasia treatment assessed by means of semiquantitative grading scales of dysphagia and gastro-esophageal reflux	1 year