NCT07181070

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 .

Conditions

• Achalasia, Esophageal
• Achalasia
• Indocyanine Green (ICG)
• Indocyanine Green

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-10-31
• Completion: 2026-10-31
• First posted: 2025-09-18
• Last updated: 2025-09-23

Locations

1 site across 1 country: Italy