Università degli Studi di Napoli, Federico II
Naples, Italy
Location status: Recruiting
NCT Number: NCT07181070
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Naples, Italy
Location status: Recruiting
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 standard of types I and II Achalasia. The use of intraoperative indocyanine green (ICG) fluorescence in recent years is becoming an interesting and innovative tool for surgical procedures. Its use is widely described in surgery The aim of our study is to value the role of ICG for this surgery. The investigators prospectively enrolled achalasic patients undergoing laparoscopic Heller -Dor .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Intraoperative
Directly visualize intraoperatively the presence or absence of an esophageal mucosal lesion through the color change due to indocyanine green fluorescence.
Time frame: intraoperative
Intraoperatively visualize the presence or absence of residual muscle fibers after myotomy through the use of indocyanine green fluorescence.
Time frame: From the first to the fourth post-operative day
days of hospitalization from first postoperative day to discarge
Time frame: Perioperative/Periprocedural
Based on Clavien-Dindo classification
Contact information is provided by the study sponsor or research team.
Federico II University
Other
The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor: a Prospective Study
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