Gynecologic CancerNCT05318170
Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)
An observational study of Gynecologic Cancer, run by University of Palermo at 1 site in Italy.
Trial summary
Although several studies have demonstrated the overall benefits of a laparoscopic approach for pelvic and para-aortic lymphadenectomy, complications remain a challenging scenario. Vascular injury occurs in 0.3% to 1.0% of laparoscopic procedures, with potentially lethal consequences. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Laparoscopic ultra-radical lymph node debulking
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 11 Apr 2022
- Phase
- Observational
- 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 80 years
- Women only
- Adult, Older adult
Study population: Women affected by gynecological cancer.
Who may be able to join
- At least one bulky lymph node with size ≥ 25 mm
- Age > 18 years
- Body mass index (BMI) < 40 kg/m²
- Absence of abdominal adhesion syndrome and intraperitoneal dissemination at the time of laparoscopic evaluation
Who cannot join
- Disease-free interval < 6 months and/or
- Performance status > 2 according to Eastern Cooperative Oncology Group (ECOG) criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies
Although several studies have demonstrated the overall benefits of a laparoscopic approach for pelvic and para-aortic lymphadenectomy, complications remain a challenging scenario. Vascular injury occurs in 0.3% to 1.0% of laparoscopic procedures, with potentially lethal consequences. Vascular injuries are usually managed using coagulation, clamps or vascular sutures, but if these measures fail, laparotomy is inevitable.
To date, few reports evaluated the use of minimally invasive surgery for lymph node debulking in gynecological cancer patients with metastatic bulky lymph nodes, with encouraging results, despite the small sample sizes. Nevertheless, new minimally invasive surgery techniques that may minimize intraoperative complications are necessary. Considering these elements, this multicenter retrospective analysis is aimed to evaluate intra- and post-operative surgical outcomes, after laparoscopic ultraradical lymph nodal debulking using Yasargil clamps in gynecological cancer patients with bulky lymph node metastases.
- Conditions
- Gynecologic Cancer
- Being tested
- Laparoscopic ultra-radical lymph node debulking
- Keywords
- Gynecological oncology, Gynecological cancers, Bulky lymph nodes, Laparoscopic ultra-radical lymph node debulking, Yasargil clamps, Complications, Surgical outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ultra-radical lymph node debulkingProcedure or surgery
Laparoscopic ultra-radical lymph node debulking using Yasargil clamps
| Study group | Role | What they receive |
|---|---|---|
| Women affected by gynecological cancer | Women affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer) Receives: Procedure: Laparoscopic ultra-radical lymph node debulking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Any complication occurred
Measured: During the surgery and within 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Apr 2022
- Primary completion8 Apr 2022
- Study completion11 Apr 2022
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 Gynecologic CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Universita di Verona
- Responsible party
- Principal investigator, Antonio Simone Laganà, University of Palermo
- Investigators
- Antonio Simone Laganà, M.D., Ph.D., Study chair, University of PalermoVito Chiantera, Study director, University of PalermoMariano Catello Di Donna, Principal investigator, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318170
- Sponsor's protocol ID
- Yasargil-1
- Status last verified
- Jul 2022
- First submitted
- 4 Apr 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Di Donna MC, Sozzi G, Cucinella G, Giallombardo V, Gallotta V, Uccella S, Garzon S, Scambia G, Lagana AS, Chiantera V. Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies: Results from a Large, Multicenter, Retrospective Analysis. J Minim Invasive Gynecol. 2022 Sep;29(9):1083-1091. doi: 10.1016/j.jmig.2022.05.016. Epub 2022 May 29.
PubMed 35649479
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT05318170
- Acronym / sponsor ID
- Yasargil-1
- Conditions
- Gynecologic Cancer
- Keywords
- Gynecological oncology, Gynecological cancers, Bulky lymph nodes, Laparoscopic ultra-radical lymph node debulking, Yasargil clamps, Complications, Surgical outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Universita di Verona
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 8 Apr 2022 (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.
Although several studies have demonstrated the overall benefits of a laparoscopic approach for pelvic and para-aortic lymphadenectomy, complications remain a challenging scenario. Vascular injury occurs in 0.3% to 1.0% of laparoscopic procedures, with potentially lethal consequences. Vascular injuries are usually managed using coagulation, clamps or vascular sutures, but if these measures fail, laparotomy is inevitable.
To date, few reports evaluated the use of minimally invasive surgery for lymph node debulking in gynecological cancer patients with metastatic bulky lymph nodes, with encouraging results, despite the small sample sizes. Nevertheless, new minimally invasive surgery techniques that may minimize intraoperative complications are necessary. Considering these elements, this multicenter retrospective analysis is aimed to evaluate intra- and post-operative surgical outcomes, after laparoscopic ultraradical lymph nodal debulking using Yasargil clamps in gynecological cancer patients with bulky lymph node metastases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women affected by gynecological cancer | – | Procedure: Laparoscopic ultra-radical lymph node debulkingWomen affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women affected by gynecological cancer.
Key inclusion criteria (4 listed)
- At least one bulky lymph node with size ≥ 25 mm
- Age > 18 years
- Body mass index (BMI) < 40 kg/m²
- Absence of abdominal adhesion syndrome and intraperitoneal dissemination at the time of laparoscopic evaluation
Key exclusion criteria (2 listed)
- Disease-free interval < 6 months and/or
- Performance status > 2 according to Eastern Cooperative Oncology Group (ECOG) criteria
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 |
|---|---|---|
| Laparoscopic ultra-radical lymph node debulkingLaparoscopic ultra-radical lymph node debulking using Yasargil clamps | Procedure or surgery | Women affected by gynecological cancer |
Primary outcome
Complications
Time frame: During the surgery and within 30 days after the surgery
Any complication occurred
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Derived from this study: PubMed 35649479Di Donna MC, Sozzi G, Cucinella G, Giallombardo V, Gallotta V, Uccella S, Garzon S, Scambia G, Lagana AS, Chiantera V. Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies: Results from a Large, Multicenter, Retrospective Analysis. J Minim Invasive Gynecol. 2022 Sep;29(9):1083-1091. doi: 10.1016/j.jmig.2022.05.016. Epub 2022 May 29.
- Individual participant dataSharing planned: Undecided
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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.
Antonio Simone Laganà, M.D., Ph.D. study chair
University of Palermo
Vito Chiantera study director
University of Palermo
Mariano Catello Di Donna principal investigator
University of Palermo
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 Gynecologic Cancer, run by University of Palermo 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jul 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complications (time frame: During the surgery and within 30 days after the 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 NCT05318170, 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 18 Jul 2022.