Epidermoid Cancer Development in Esophageal Achalasia

• Sponsor: Sandro Mattioli (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03546998
• Collaborator: (none)
• Enrollment: 681
• Location: 1
• Anticipated Duration (Months): 636
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Achalasia; Epidermoid Carcinoma	Diagnostic Test: Clinical instrumental examinations

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 681 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Incidence and Risk Factors for Development of Epidermoid Carcinoma in Esophageal Achalasia
• Actual Study Start Date: Jan 1, 1973
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Outcome Measures

Primary Outcome Measures

1. Detection of epidermoid carcinoma of the esophagus [1 year]

   Detection of epidermoid carcinoma of the esophagus by means of upper GI endoscopy

Secondary Outcome Measures

1. Result of achalasia treatment by investigating dysphagia and gastro-esophageal reflux [1 year]

   Result of achalasia treatment assessed by means of semiquantitative grading scales of dysphagia and gastro-esophageal reflux

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• pseudoachalasia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Thoracic Surgery Maria Cecilia Hospital	Cotignola	RA	Italy

Sponsors and Collaborators

• Sandro Mattioli

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sandro Mattioli, Prof. Sandro Mattioli, University of Bologna
• ClinicalTrials.gov Identifier: NCT03546998
• Other Study ID Numbers: Epidermoid cancer in achalasia
• First Posted: Jun 6, 2018
• Last Update Posted: Jun 6, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sandro Mattioli, Prof. Sandro Mattioli, University of Bologna: epidermoid carcinoma; esophageal achalasia; risk factors
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Achalasia

Study Results

No Results Posted as of Jun 6, 2018