Neoplasms

Digestive System Diseases

All Conditions

Wounds and Injuries

Symptoms and General Pathology

Ear, Nose, and Throat Diseases

Rare Diseases

Esophageal Neoplasms

Esophageal Achalasia

Esophageal Diseases

Anastomotic Leak

Esophageal Perforation

Gastrointestinal Diseases

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Cancer

Idiopathic Achalasia

Cardiospasm

Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract

VACStent

Seung-Hun Chon, M.D.

Open, prospective, one-arm feasibility and efficacy study of a European conformity (CE) certified Combination product of two CE certified medical devices in the intended indication.

Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract

The investigators analyzed the outcome of using a hybrid medical device (self-expanding metal stents (SEMS) with negative pressure wound therapy) in the treatment of leaks of the upper gastrointestinal tract

Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)

VAC Stent: A Prospective Feasibility Study for the Treatment of Gastrointestinal Leakage Through a Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment

% of patients with successful implantation of VACStent

% of patients with a sealed leak after successful treatment with VACStent

% of patients with successful treatment of sepsis leak after successful implantation of VACStent

% of patients with migration of VACStent after successful implantation of VACStent

% of patients with bleeding after successful implantation of VACStent

% of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with VACStent

University Hospital of Cologne

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

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.

Clinical instrumental examinations

Sandro Mattioli, MD

Marisaluisa Lugaresi, MD

Marialuisa Lugaresi, MD

Valentina Tassi, MD

Niccolò Daddi, MD

Benedetta Mattioli, MD

Francesca Fortunato, PhD

Rocco Maurizio Zagari, MD

Francesco Bassi, MD

Vladimiro Pilotti, MD

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.

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.

Epidermoid Cancer Development in Esophageal Achalasia

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)	NCT03962179	Perforation Eso... Esophageal Canc... Esophageal Acha... Esophageal Dise...	VACStent	18 Years -	University Hospital of Cologne
Epidermoid Cancer Development in Esophageal Achalasia	NCT03546998	Achalasia Epidermoid Carc...	Clinical instru...	-	University of Bologna
Epidermoid Cancer Development in Esophageal Achalasia	NCT03546998	Achalasia Epidermoid Carc...	Clinical instru...	-	University of Bologna

Spots Global Cancer Trial Database for esophageal achalasia