Actively Recruiting
The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor
Led by Federico II University · Updated on 2025-09-23
70
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 with use of ICG iatrogenic mucosal leaks can be identified and, if necessary, improve the myotomy. * Assess the need for postoperative radiographic control using esophagogastric radiography with gastrografin. * Compare clinical characteristics, perioperative outcomes, and 12-month postoperative follow-up between the two populations.
CONDITIONS
Official Title
The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with achalasia of type I and II
- Patients undergoing laparoscopic Heller-Dor
- Patients older than 18 years
You will not qualify if you...
- Patients younger than 18 years
- Uncooperative patients or those unable to provide informed consent
- ASA score 4 or higher
- Body mass index of 30 or higher
- Patients previously treated with other endoscopic or surgical procedures such as botulinum toxin injections, dilation, POEM, or myotomy
- Patients with achalasia type III
- Patients with megaesophagus
- Allergy to dyes or contrast agents used in the study (e.g., indocyanine green, barium, gastrografin)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Università degli Studi di Napoli, Federico II
Naples, Italy
Actively Recruiting
Research Team
D
Dr. Giuseppe Palomba, MD, Phd fellow
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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