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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2026-10-31

Brief Summary

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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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Detailed Description

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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

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Achalasia, Esophageal Achalasia Indocyanine Green (ICG) Indocyanine Green

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard group

IGC group

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No