Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)

NCT ID: NCT05318170

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-04-11

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecologic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Women affected by gynecological cancer

Women affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer)

Laparoscopic ultra-radical lymph node debulking

Intervention Type PROCEDURE

Laparoscopic ultra-radical lymph node debulking using Yasargil clamps

Interventions

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Laparoscopic ultra-radical lymph node debulking

Laparoscopic ultra-radical lymph node debulking using Yasargil clamps

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Disease-free interval \< 6 months and/or
* Performance status \> 2 according to Eastern Cooperative Oncology Group (ECOG) criteria
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario A. Gemelli, IRCCS

UNKNOWN

Sponsor Role collaborator

Universita di Verona

OTHER

Sponsor Role collaborator

University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Antonio Simone Laganà

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Simone Laganà, M.D., Ph.D.

Role: STUDY_CHAIR

University of Palermo

Vito Chiantera

Role: STUDY_DIRECTOR

University of Palermo

Mariano Catello Di Donna

Role: PRINCIPAL_INVESTIGATOR

University of Palermo

Locations

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University of Palermo

Palermo, Sicily, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 35649479 (View on PubMed)

Other Identifiers

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Yasargil-1

Identifier Type: -

Identifier Source: org_study_id

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