Achalasia, Achalasia, Esophageal, Indocyanine Green, Indocyanine Green (ICG)
Conditions
Keywords
achalasia, Laparoscopic Heller-Dor, Indocyanine Green Fluorescence
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.
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 .
Interventions
None listed
Sponsors
Federico II University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mucosal leak | Intraoperative | Directly visualize intraoperatively the presence or absence of an esophageal mucosal lesion through the color change due to indocyanine green fluorescence. |
| Completeness of myotomy | intraoperative | Intraoperatively visualize the presence or absence of residual muscle fibers after myotomy through the use of indocyanine green fluorescence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | From the first to the fourth post-operative day | days of hospitalization from first postoperative day to discarge |
| Perioperative complications | Perioperative/Periprocedural | Based on Clavien-Dindo classification |
Countries
Italy
Contacts
Primary ContactDr. Giuseppe Palomba, MD, Phd fellow
Outcome results
None listed