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

Recruitingn/aAges 18 Years - anyAllFederico II University
NCT07181070 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Not listed
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Where

1 site
Università degli Studi di Napoli, Federico II
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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