NCT07181070 The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor
| NCT ID | NCT07181070 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federico II University |
| Condition | Achalasia, Esophageal |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2022-11-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Giovanni Aprea, Prof.
STUDY DIRECTOR
Federico II University
Frequently Asked Questions
Who can join the NCT07181070 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Achalasia, Esophageal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07181070 currently recruiting?
Yes, NCT07181070 is actively recruiting participants. Contact the research team at giuseppe.palomba@unina.it for enrollment information.
Where is the NCT07181070 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT07181070 clinical trial?
NCT07181070 is sponsored by Federico II University. The principal investigator is Giovanni Aprea, Prof. at Federico II University. The trial plans to enroll 70 participants.