Status:
RECRUITING
The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor
Lead Sponsor:
Federico II University
Conditions:
Achalasia, Esophageal
Achalasia
Eligibility:
All Genders
18+ years
Brief Summary
The aim this prospective observational study is to evaluate the role of Indocyanine Green Fluorescence (ICG) in patients with achalasia underwent to Heller-Dor laparoscopic. The main gol are: * If wi...
Detailed Description
Achalasia is a rare disease of motility characterized by dysfunction of low esophageal sphincter (LES). This disease is divided according to Chicago classification. Laparoscopic Heller - Dor is gold s...
Eligibility Criteria
Inclusion
- patients with achalasia of type I and II
- patients undergoing laparoscopic Heller-Dor
- patients older than 18 years
Exclusion
- Patients \<18 years of age;
- Uncooperative patients and/or patients unable to provide informed consent
- ASA ≥4
- BMI ≥30
- Patients previously treated with other endoscopic/surgical procedures (botulinum toxin injections, dilation, POEM, myotomy)
- Patients with achalasia type III
- Patients with megaesophagus
- Allergy to dyes or contrast agents included in the protocol (e.g., indocyanine green, barium, gastrografin)
Key Trial Info
Start Date :
November 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07181070
Start Date
November 1 2022
End Date
October 31 2026
Last Update
September 23 2025
Active Locations (1)
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1
Università degli Studi di Napoli, Federico II
Napoli, Italy