The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor

NCT07181070 | Recruiting

• 1 other identifier: 09082022
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Achalasia, Esophageal; Achalasia; Indocyanine Green (ICG); Indocyanine Green

Keywords

achalasia; Laparoscopic Heller-Dor; Indocyanine Green Fluorescence

Outcome Measures

Primary Outcomes (2)

• mucosal leak

  Directly visualize intraoperatively the presence or absence of an esophageal mucosal lesion through the color change due to indocyanine green fluorescence.

  Intraoperative

• Completeness of myotomy

  Intraoperatively visualize the presence or absence of residual muscle fibers after myotomy through the use of indocyanine green fluorescence.

  intraoperative

Secondary Outcomes (2)

• Length of stay

  From the first to the fourth post-operative day

• Perioperative complications

  Perioperative/Periprocedural

Study Arms (1)

Standard group

IGC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Each patient has type I or type II esophageal achalasia and was treated with the Heller-Dor laparoscopic surgery.

You may qualify if:

• patients with achalasia of type I and II
• patients undergoing laparoscopic Heller-Dor
• patients older than 18 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Università degli Studi di Napoli, Federico II

Napoli, Italy

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Giovanni Aprea, Prof.

  Federico II University

  STUDY DIRECTOR

Central Study Contacts

Dr. Giuseppe Palomba, MD, Phd fellow

CONTACT

+393381155483; giuseppe.palomba@unina.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 18, 2025
• Study Start: November 1, 2022
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

IT (1)