Robotic Heller-Dor procedure for oesophageal achalasia: Fluorescence-guided intraoperative assessment of myotomy. A retrospective single-centre experience.
Andrea Romanzi, Lucia D'Alba, Pasquale Campagna...
https://pubmed.ncbi.nlm.nih.gov/35472736Actively Recruiting
Age: 18Years +
All Genders
ID07181070
The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller-Dor: a Prospective Study
Led by Federico II University · Updated on 2025-09-23
70
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Achalasia is a rare disorder affecting the movement of the lower esophageal sphincter, classified into types I, II, and III. This study focuses on patients with types I and II achalasia undergoing laparoscopic Heller-Dor surgery, which is the standard treatment for these types. Researchers are evaluating the potential role of Indocyanine Green Fluorescence (ICG) during this surgery to better detect mucosal leaks and improve surgical outcomes. The study observes patients undergoing the laparoscopic Heller-Dor procedure with the use of ICG fluorescence as a tool during surgery. The investigators aim to determine if ICG can identify intraoperative mucosal leaks and guide myotomy adjustments. They also plan to assess the need for postoperative esophagogastric radiographic control and compare clinical features, perioperative outcomes, and follow-up results over 12 months between patients with and without ICG use. Participants will be monitored through clinical assessments, perioperative complication tracking, and length of hospital stay from the first to fourth postoperative day. The primary outcomes measured are intraoperative detection of mucosal leaks and completeness of the myotomy. Secondary outcomes include perioperative complications and postoperative recovery. Follow-up will extend to 12 months to evaluate longer-term results and the potential benefits of using ICG during surgery.
CONDITIONS
Brief Title
The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with achalasia of type I and II
- Patients undergoing laparoscopic Heller-Dor
- Patients older than 18 years
You will not qualify if you...
- Patients younger than 18 years of age
- Uncooperative patients and/or patients unable to provide informed consent
- ASA score of 4 or higher
- Body mass index (BMI) of 30 or higher
- Patients previously treated with other endoscopic or 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 (such as indocyanine green, barium, gastrografin)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo laparoscopic Heller-Dor surgery with the use of indocyanine green (ICG) fluorescence during the procedure to assist the surgical process.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to 4 days post surgery
Participants are monitored for perioperative complications and recovery, including length of hospital stay from the first to the fourth post-operative day.
Approximately 4 post-operative visits (in-person)
Trial Site Locations
Total: 1 location
1
Università degli Studi di Napoli, Federico II
Naples, Italy
Actively Recruiting
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Research Team
D
Dr. Giuseppe Palomba, MD, Phd fellow
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Is Indocyanine Green the New Gold Standard for Checking Completion of Laparoscopic Heller's Cardiomyotomy?
Jainil Patel, Vishakha Kalikar, Roysuneel Patankar...
https://pubmed.ncbi.nlm.nih.gov/39781145Nasogastric tube after laparoscopic Heller-Dor surgery: Do you really need it?
Giuseppe Palomba, Raffaele Basile, Marianna Capuano...
https://pubmed.ncbi.nlm.nih.gov/38548426