INCIDENCE, PREVALENCE AND OVERALL RISK OF ESOPHAGEAL CANCER IN ACHALASIA: A PROPENSITY-MATCHED POPULATION-BASED STUDY FROM A LARGE MULTICENTER DATABASE

NCT07022886 | Active Not Recruiting

• 1 other identifier: RECAP
• Study Type: observational
• Target: 47,000
• Locations: 1 country
• Sites: 1

Brief Summary

Esophageal Achalasia has been investigated as a potential risk factor for esophageal cancer (EC). Longstanding disease, repeated treatment, age and male sex seem the most relevant risk factors, but no clear effect size estimation from large sample cohorts has been provided so far. The aim of the investigators is to estimate EC risk in large sample-size population, and to provide sub-analyses per cancer type and treatment impact on EC risk.

Conditions

Achalasia Cardia; Esophageal Cancer (EsC)

Keywords

achalasia; esophageal cancer

Outcome Measures

Primary Outcomes (2)

• Hazard Ratio

  Hazard Ratio (HR) with Kaplan Meyer (KM) analysis of EC occurrence in achalasia vs control subjects

  from Jan 1st 2000 to June 3rd 2025

• Incidence proportion, prevalence and incidence rate

  Incidence proportion (%), prevalence (%) and incidence rate (100,000 persons-year) of EC (and different histological subtypes)

  Jan 1st 2000- June 3rd 2025

Secondary Outcomes (3)

• Risk Ratio

  Jan 1st 2000-Jun 3rd 2025

• Risk Difference

  Jan 1st 2000-June 3rd 2025

• Hazard Ratio (HR) with Kaplan Meyer (KM) analysis of EC occurrence

  Jan 1st 2000- June 3rd 2025

Study Arms (7)

Achalasia primary cohort

Achalasia cohort (both naive or treated)

Control subjects

Healthy controls, with the exclusion of achalasia

Achalasia without Barrett Esophagus

Sensitivity analysis of achalasia both treated or untreated without Barrett esophagus

Treated achalasia

achalasia undergone to various treatments

Procedure: achalasia treatments

Untreated achalasia

Achalasia without previous treatment

LHM

Heller-Dor myotomy

Procedure: achalasia treatments

POEM

Peroral endoscopic myotomy

Procedure: achalasia treatments

Interventions

achalasia treatments PROCEDURE

esophageal achalasia treatments

Also known as: POEM, LHM

LHM; POEM; Treated achalasia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Achalasia diagnosis according to guidelines as stated in Electronic Health Records (EHR) data.

You may qualify if:

• Esophageal achalasia diagnosed according to guidelines (ICD-10-K22.0)

You may not qualify if:

• Primary esophaeal and pharyngeal motility disorders (ICD-10-J39.2)

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• TriNetX, LLC: collaborator
• Vita-Salute San Raffaele University: collaborator

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, Lombardy, 20132, Italy

Location

Related Publications (3)

• Ponds FA, Moonen A, Smout AJPM, Rohof WOA, Tack J, van Gool S, Bisschops R, Bredenoord AJ, Boeckxstaens GE. Screening for dysplasia with Lugol chromoendoscopy in longstanding idiopathic achalasia. Am J Gastroenterol. 2018 Jun;113(6):855-862. doi: 10.1038/s41395-018-0064-1.

  PMID: 29748564 BACKGROUND

• Tustumi F, Bernardo WM, da Rocha JRM, Szachnowicz S, Seguro FC, Bianchi ET, Sallum RAA, Cecconello I. Esophageal achalasia: a risk factor for carcinoma. A systematic review and meta-analysis. Dis Esophagus. 2017 Oct 1;30(10):1-8. doi: 10.1093/dote/dox072.

  PMID: 28859394 BACKGROUND

• Gillies CL, Farrukh A, Abrams KR, Mayberry JF. Risk of esophageal cancer in achalasia cardia: A meta-analysis. JGH Open. 2019 Feb 8;3(3):196-200. doi: 10.1002/jgh3.12132. eCollection 2019 Jun.

  PMID: 31276035 BACKGROUND

Related Links

• TriNetX platform link

MeSH Terms

Conditions

Esophageal Achalasia; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Albert Jan Bredenoord, MD, PhD, Prof

  Department of Gastroenterology, Amsterdam UMC Location AMC, Amsterdam, The Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 15, 2025
• Study Start: June 3, 2025
• Primary Completion: June 3, 2025
• Study Completion: September 7, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)