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NCT Number: NCT07181070

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Università degli Studi di Napoli, Federico II

Naples, Italy

Location status: Recruiting

Location contact

Giuseppe Palomba

CONTACT

[email protected]

+393381155483

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. mucosal leak

    Time frame: Intraoperative

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

  2. Completeness of myotomy

    Time frame: intraoperative

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

Secondary outcomes

  1. Length of stay

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

    days of hospitalization from first postoperative day to discarge

  2. Perioperative complications

    Time frame: Perioperative/Periprocedural

    Based on Clavien-Dindo classification

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Giuseppe Palomba, MD, Phd fellow

CONTACT

[email protected]

+393381155483

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor: a Prospective Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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