Achalasia, EsophagealNCT07181070
The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor
An observational study of Achalasia, Esophageal and Achalasia, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia, Esophageal, Achalasia, Indocyanine Green (ICG)
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2022to 31 Oct 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Each patient has type I or type II esophageal achalasia and was treated with the Heller-Dor laparoscopic surgery.
Who may be able to join
- patients with achalasia of type I and II
- patients undergoing laparoscopic Heller-Dor
- patients older than 18 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università degli Studi di Napoli, Federico II
Naples
Giuseppe Palomba, +393381155483, giuseppe.palomba@unina.it
About this study
Official title: The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor: a Prospective Study
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.
Read the 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 .
- Keywords
- achalasia, Laparoscopic Heller-Dor, Indocyanine Green Fluorescence
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | IGC group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mucosal leak
Directly visualize intraoperatively the presence or absence of an esophageal mucosal lesion through the color change due to indocyanine green fluorescence.
Measured: Intraoperative
Completeness of myotomy
Intraoperatively visualize the presence or absence of residual muscle fibers after myotomy through the use of indocyanine green fluorescence.
Measured: intraoperative
Secondary outcomes (2)
Length of stay
days of hospitalization from first postoperative day to discarge
Measured: From the first to the fourth post-operative day
Perioperative complications
Based on Clavien-Dindo classification
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Nov 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Achalasia, EsophagealStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Palomba, Federico II University
- Investigators
- Giovanni Aprea, Prof., Study director, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181070
- Sponsor's protocol ID
- 09082022
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35472736Patel 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.
PubMed 39781145Palomba 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.
PubMed 38548426Palomba G, Capuano M, Simeone AL, Pesce M, Sarnelli G, Aprea G. Intraoperative indocyanine green (ICG) fluorescence to assess mucosal integrity during laparoscopic Heller-Dor surgery: a pilot randomized study. Updates Surg. 2026 Aug 28. doi: 10.1007/s13304-026-02806-4. Online ahead of print.
PubMed 42663942
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor: a Prospective Study
- ClinicalTrials.gov ID
- NCT07181070
- Acronym / sponsor ID
- 09082022
- Keywords
- achalasia, Laparoscopic Heller-Dor, Indocyanine Green Fluorescence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard group | – | –IGC group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each patient has type I or type II esophageal achalasia and was treated with the Heller-Dor laparoscopic surgery.
Key inclusion criteria (3 listed)
- patients with achalasia of type I and II
- patients undergoing laparoscopic Heller-Dor
- patients older than 18 years
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mucosal leak
Time frame: 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
Time frame: intraoperative
Intraoperatively visualize the presence or absence of residual muscle fibers after myotomy through the use of indocyanine green fluorescence.
2 secondary outcomes
Length of stay
Time frame: From the first to the fourth post-operative day
Perioperative complications
Time frame: Perioperative/Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Background: PubMed 35472736Romanzi 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.
- Background: PubMed 39781145Patel 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.
- Background: PubMed 38548426Palomba 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.
- Derived from this study: PubMed 42663942Palomba G, Capuano M, Simeone AL, Pesce M, Sarnelli G, Aprea G. Intraoperative indocyanine green (ICG) fluorescence to assess mucosal integrity during laparoscopic Heller-Dor surgery: a pilot randomized study. Updates Surg. 2026 Aug 28. doi: 10.1007/s13304-026-02806-4. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Aprea, Prof. study director
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia, Esophageal and Achalasia, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Giuseppe Palomba, MD, Phd fellow (+393381155483, giuseppe.palomba@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mucosal leak (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07181070, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.