EndometriosisNCT03950206
Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis
A study testing Indocyanine green angiography in people with Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Deep infiltrating endometriosis (DIE) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. It is often characterized by pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically impacting on women' quality of life. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Indocyanine green angiography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2019to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients undergoing laparoscopic surgery for endometriosis
- informed consent to participate in the study
Who cannot join
- known or suspected allergy to iodide
- history of active pelvic infection
- presence of intra-abdominal or pelvic malignancy
- pelvic radiation therapy
- hyperthyroidism
- liver dysfunction
- serum creatinine > 2.0 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Assessment of Ureteral Perfusion Using Indocyanine Green Angiography in Women Submitted to Laparoscopic Surgery for Endometriosis
Deep infiltrating endometriosis (DIE) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. It is often characterized by pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically impacting on women' quality of life. It is typically multifocal, involving uterosacral ligaments, the upper third of posterior vaginal wall, bowel, bladder, and ureters.
Indocyanine green (ICG) is an anionic tricarbocyanine molecule able to bind to plasma proteins into the vascular system and to become fluorescent if excited by near-infrared light (NIR). NIR-ICG imaging is used in gynecology for the intraoperative diagnosis of occult peritoneal and deep endometriosis at white light and to assess tissue perfusion and guide surgical strategy.
Read the detailed description
Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of deep endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.
Ureter perfusion will be intraoperatively assessed using indocyanine green angiography.
After surgery, patients will be included in the post-operative follow-up, as usual in our clinical practice.
- Conditions
- Endometriosis
- Being tested
- Indocyanine green angiography
- Keywords
- Endometriosis, Ureters, Indocyanine green angiography
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green angiographyOther
Intravenous ICG (PULSION Medical Systems SE, Feldkirchen, Germany) will be used for the intraoperative evaluation of ureteral vascularization. Twenty-five milligrams of indocyanine green will be diluted in 10 ml of soluble water, and a bolus of 0.25 mg/Kg will be injected through a peripheral vein. During laparoscopy, a NIR camera-head (KARL STORZ Gesellschaft Mit Beschränkter Haftung\& Co., Tuttlingen, Germany) will be used to visualize the ureteral vascularization.
| Study group | Role | What they receive |
|---|---|---|
| Women with endometriosis | Other | Women undergoing laparoscopic surgery for endometriosis Receives: Other: Indocyanine green angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
Evaluation of feasibility and safety of indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis, considering complications using Clavien-Dindo Classification (from Grade I to V)
Measured: From the surgery time, assessed up to 7 days after surgery
Secondary outcomes (1)
Ureteral vascularization
Evaluation of ureteral vascularization using indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jun 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Why it stopped: PI decided to terminate the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Seracchioli, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950206
- Sponsor's protocol ID
- ICG and endometriosis
- Status last verified
- Nov 2019
- First submitted
- 13 May 2019
- Last updated
- 22 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raimondo D, Borghese G, Mabrouk M, Arena A, Ambrosio M, Del Forno S, Degli Esposti E, Casadio P, Mattioli G, Mastronardi M, Seracchioli R. Use of Indocyanine Green for Intraoperative Perfusion Assessment in Women with Ureteral Endometriosis: A Preliminary Study. J Minim Invasive Gynecol. 2021 Jan;28(1):42-49. doi: 10.1016/j.jmig.2020.04.004. Epub 2020 Apr 10.
PubMed 32283326
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Assessment of Ureteral Perfusion Using Indocyanine Green Angiography in Women Submitted to Laparoscopic Surgery for Endometriosis
- ClinicalTrials.gov ID
- NCT03950206
- Acronym / sponsor ID
- ICG and endometriosis
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Ureters, Indocyanine green angiography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI decided to terminate the trial
- Enrolment
- 23 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 15 May 2019 (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.
Deep infiltrating endometriosis (DIE) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. It is often characterized by pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically impacting on women' quality of life. It is typically multifocal, involving uterosacral ligaments, the upper third of posterior vaginal wall, bowel, bladder, and ureters.
Indocyanine green (ICG) is an anionic tricarbocyanine molecule able to bind to plasma proteins into the vascular system and to become fluorescent if excited by near-infrared light (NIR). NIR-ICG imaging is used in gynecology for the intraoperative diagnosis of occult peritoneal and deep endometriosis at white light and to assess tissue perfusion and guide surgical strategy.
Detailed description
Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of deep endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.
Ureter perfusion will be intraoperatively assessed using indocyanine green angiography.
After surgery, patients will be included in the post-operative follow-up, as usual in our clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with endometriosis | Other | Other: Indocyanine green angiographyWomen undergoing laparoscopic surgery for endometriosis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients undergoing laparoscopic surgery for endometriosis
- informed consent to participate in the study
Key exclusion criteria (7 listed)
- known or suspected allergy to iodide
- history of active pelvic infection
- presence of intra-abdominal or pelvic malignancy
- pelvic radiation therapy
- hyperthyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine green angiographyIntravenous ICG (PULSION Medical Systems SE, Feldkirchen, Germany) will be used for the intraoperative evaluation of ureteral vascularization. Twenty-five milligrams of indocyanine green will be diluted in 10 ml of soluble water, and a bolus of 0.25 mg/Kg will be injected through a peripheral vein. During laparoscopy, a NIR camera-head (KARL STORZ Gesellschaft Mit Beschränkter Haftung\& Co., Tuttlingen, Germany) will be used to visualize the ureteral vascularization. | Other | Women with endometriosis |
Primary outcome
Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
Time frame: From the surgery time, assessed up to 7 days after surgery
Evaluation of feasibility and safety of indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis, considering complications using Clavien-Dindo Classification (from Grade I to V)
1 secondary outcome
Ureteral vascularization
Time frame: Intraoperative
Results and safety
The study was stopped early (reason given: PI decided to terminate the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Derived from this study: PubMed 32283326Raimondo D, Borghese G, Mabrouk M, Arena A, Ambrosio M, Del Forno S, Degli Esposti E, Casadio P, Mattioli G, Mastronardi M, Seracchioli R. Use of Indocyanine Green for Intraoperative Perfusion Assessment in Women with Ureteral Endometriosis: A Preliminary Study. J Minim Invasive Gynecol. 2021 Jan;28(1):42-49. doi: 10.1016/j.jmig.2020.04.004. Epub 2020 Apr 10.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green angiography in people with Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Jun 2021. 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?
The study was stopped early (reason given: PI decided to terminate the trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and safety: Clavien-Dindo Classification (from Grade I to V) (time frame: From the surgery time, assessed up to 7 days after surgery). 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 NCT03950206, which also lists 1 linked publication.
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 22 Jun 2021.