Indocyanine green fluorescence during laparoscopic Heller–Dor for achalasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study at Università degli Studi di Napoli Federico II enrolling adults with type I or II achalasia who are undergoing laparoscopic Heller‑Dor. Surgeons will administer indocyanine green (ICG) intraoperatively and use fluorescence imaging to detect any iatrogenic mucosal leaks and, if present, adjust the myotomy accordingly. The protocol also records whether ICG use affects the need for postoperative contrast radiography with gastrografin and collects perioperative outcome data. Patients will be followed for clinical outcomes and complications for 12 months after surgery.

Why it matters

Who can join: the full rules

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)

Where it's running

• Università degli Studi di Napoli, Federico II
  Naples, Italy Recruiting

Study contacts

• Study coordinator: Dr. Giuseppe Palomba, MD, Phd fellow
• Email: giuseppe.palomba@unina.it
• Phone: +393381155483

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.