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

ConditionsAchalasia, EsophagealAchalasiaIndocyanine Green (ICG)Indocyanine Green
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFederico II University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

patients with achalasia of type I and II

patients undergoing laparoscopic Heller-Dor

patients older than 18 years

Disqualifiers

Patients <18 years of age;

Uncooperative patients and/or patients unable to provide informed consent

ASA ≥4

BMI ≥30

Trial population

Each patient has type I or type II esophageal achalasia and was treated with the Heller-Dor laparoscopic surgery.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 1 trial group
Group A: Standard group

Trial outcomes

Primary outcomes

1

mucosal leak

Directly visualize intraoperatively the presence or absence of an esophageal mucosal lesion through the color change due to indocyanine green fluorescence.

Time frame
Intraoperative
2

Completeness of myotomy

Intraoperatively visualize the presence or absence of residual muscle fibers after myotomy through the use of indocyanine green fluorescence.

Time frame
intraoperative

Secondary outcomes

1

Length of stay

days of hospitalization from first postoperative day to discarge

Time frame
From the first to the fourth post-operative day
2

Perioperative complications

Based on Clavien-Dindo classification

Time frame
Perioperative/Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Federico II University

Lead sponsor

Source ClinicalTrials.gov
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