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

Federico II University

Status: Enrolling

Conditions: Achalasia, Esophageal; Indocyanine Green; Achalasia; Indocyanine Green (ICG)

Study type: Observational

Funder types: Other

Identifiers

NCT07181070

09082022

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

70 participants in 1 patient group

Standard group

Description:

IGC group