The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor
The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor: a Prospective Study
Federico II University
70 participants
Nov 1, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- patients with achalasia of type I and II
- patients undergoing laparoscopic Heller-Dor
- patients older than 18 years
Exclusion Criteria8
- 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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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07181070