The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Achalasia, Esophageal, Achalasia, Indocyanine Green (ICG), Indocyanine Green. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor: a Prospective Study
Overview
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.
Detailed description
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 .
Primary outcome measures
- mucosal leak [Time frame: Intraoperative]
- Completeness of myotomy [Time frame: intraoperative]
Secondary outcome measures (2)
- Length of stay [Time frame: From the first to the fourth post-operative day]
- Perioperative complications [Time frame: Perioperative/Periprocedural]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Università degli Studi di Napoli, Federico II — Naples
Publications
- Romanzi A, D'Alba L, Campagna P, Mancini R, Pernazza G. Robotic Heller-Dor procedure for oesophageal achalasia: Fluorescence-guided intraoperative assessment of myotomy. A retrospective single-centre experience. Int J Med Robot. 2022 Aug;18(4):e2411. doi: 10.1002/rcs.2411. Epub 2022 May 4. PMID 35472736
- Patel J, Kalikar V, Patankar R, Supe A. Is Indocyanine Green the New Gold Standard for Checking Completion of Laparoscopic Heller's Cardiomyotomy? Cureus. 2024 Dec 8;16(12):e75344. doi: 10.7759/cureus.75344. eCollection 2024 Dec. PMID 39781145
- Palomba G, Basile R, Capuano M, Pesce M, Rurgo S, Sarnelli G, De Palma GD, Aprea G. Nasogastric tube after laparoscopic Heller-Dor surgery: Do you really need it? Curr Probl Surg. 2024 Apr;61(4):101457. doi: 10.1016/j.cpsurg.2024.101457. Epub 2024 Feb 15. No abstract available. PMID 38548426
Identifiers
NCT: NCT07181070 · 09082022