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Clinical Trials in Italy / NCT07181070
Recruiting Observational

The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor

NCT07181070 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-11-01
Last updated
2025-09-23

Condition(s) studied

Achalasia, EsophagealAchalasiaIndocyanine Green (ICG)Indocyanine Green

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * patients with achalasia of type I and II * patients undergoing laparoscopic Heller-Dor * patients older than 18 years Exclusion Criteria: * 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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Università degli Studi di Napoli, Federico II Naples Italy Recruiting

More Federico II University trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07181070 on ClinicalTrials.gov ↗ ← All trials in Italy