Indocyanine green fluorescence during laparoscopic Heller–Dor for achalasia
The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor: a Prospective Study
This study will try using indocyanine green dye during laparoscopic Heller‑Dor in adults with type I or II achalasia to find mucosal leaks during surgery and help guide repairs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT07181070 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults over 18 with type I or II achalasia scheduled for laparoscopic Heller‑Dor who have BMI <30, ASA <4, no prior endoscopic or surgical achalasia treatments, and no allergy to ICG or contrast agents are appropriate candidates.
Not a fit: Patients with type III achalasia, megaesophagus, prior myotomy/POEM or dilation, BMI ≥30, ASA ≥4, children, or those allergic to ICG or contrast agents are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, intraoperative ICG could allow earlier detection and repair of mucosal injuries, potentially reducing postoperative complications and the need for routine radiographic controls.
How similar studies have performed: ICG fluorescence has been used successfully in many surgical fields for perfusion and leak detection, but its specific use to detect mucosal leaks during Heller‑Dor is relatively novel with limited published evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Naples
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.