MelanomaNCT02508909
Videoscopic Ilioinguinal Lymphadenectomy for Melanoma
A study testing Videoscopic ilioinguinal dissection in people with Melanoma and Secondary Malignant Neoplasm of Lymph Node, run by Istituto Oncologico Veneto IRCCS.
Trial summary
Groin lymph node dissection for melanoma patients is burdened by high post-operative morbidity, mainly related to wound. This is a prospective pilot trial investigated feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in patients with inguinal lymph node melanoma metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Secondary Malignant Neoplasm of Lymph Node
- What is being tested?
- Videoscopic ilioinguinal dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Melanoma patients without distant metastasis and either positive SLNB or clinically positive inguinal lymph nodes
Who cannot join
- American Society of Anaesthesiologists (ASA) classification III-IV Severe chronic obstructive pulmonary disease (COPD) and other restrictive lung disease, Severe ischemic heart disease and chronic heart failure Previous cerebral abnormalities (aneurysm/arteriovenous malformations, ischemic/hemorrhagic stroke, primary or secondary tumors), History of deep vein thrombosis (DVT) Childbearing state Severe hip functional limitation Previous hip/knee arthroplasty. Previous surgery in the groin region (e.g., hernia repair, great saphenous vein surgery, iliac-femoral bypass) was considered a contraindication only for the iliac stage of lymphadenectomy.
About this study
Official title: Videoscopic Ilioinguinal Lymphadenectomy for Groin Lymph Node Metastases From Melanoma
Groin lymph node dissection for melanoma patients is burdened by high post-operative morbidity, mainly related to wound. This is a prospective pilot trial investigated feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in patients with inguinal lymph node melanoma metastases.
Read the detailed description
Videoscopic ilioinguinal dissection is a two-stage procedure. Dissection is performed using an ultrasound dissector. The inguinal step is performed via three ports (one 3-5 cm above the apex of the femoral triangle, a second 5 cm medial to the adductors, and the third 5 cm lateral to the Sartorius muscle). After subcutaneous inflation, a formal inguinal lymph node (LN) dissection is performed, removing the contents of the femoral triangle, with incision and removal of the femoral fascia and proximal and distal ligation of the saphenous vein with vascular endostaplers and endoclips. The specimen is extracted using an endobag from the incision of SLNB, which is systematically removed, or through a small enlargement of the incision of the apex trocar for patients with clinically positive LNs. The iliac step starts with open insertion in the pro-peritoneal space of a Hasson trocar, followed by positioning of two additional trocars (5 and 10 mm respectively) just laterally of the umbilical pubic line. After creation of pneumo-pelvis, the iliac femoral vessels are identified, isolated and all the external iliac LNs removed. Afterwards, the obturator LNs are dissected off the obturator nerve. LNs are retrieved with an endobag or directly through the 10mm trocar after insertion of protective endotrocar. Two drains are positioned at the end of procedure in the obturator fossa and in the inguinal space, respectively. Intra-operative and early post-operative outcome (lenght of stay, complications, number of LNs) is recorded. Follow-up consists in detection of any recurrence, measurement of lymphedema of the leg and evaluation of quality of life
- Being tested
- Videoscopic ilioinguinal dissection
- Keywords
- Videoassisted surgery
- Medical subject headings
- Melanoma, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videoscopic ilioinguinal dissectionProcedure or surgery
Also called Videoscopic groin lymphadenectomy
Inguinal dissection is performed after subcutaneous inflation via three ports. Iliac dissection is obtained through a pro-peritoneal access.
| Study group | Role | What they receive |
|---|---|---|
| Videoscopic ilioinguinal lymphadenectomy for melanoma | Experimental | Melanoma groin lymph node metastasis. Receives: Procedure: Videoscopic ilioinguinal dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative complications
Frequency, type and severity of operative complications according to the Clavien-Dindo classification. Grade I: no intervention required; Grade II: medical therapy resolved the complication; Grade III A: intervention without general anaesthesia; Grade III B: intervention under general anaesthesia.
Measured: 30 days
Secondary outcomes (4)
Leg lymphedema
Lymphedema is measured pre-operatively at 3, 6 and 12 months after surgery. Number of patients with lymphedema according to the definition of the percent change > or = 7% of the sum of circumferences of the lower limb.
Measured: Up to 12 months
Quality of life
Quality of life was evaluated with European Organization Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ-C30) administered pre-operatively and after 3-6 and 9-12 months after surgery.This questionnaire is made up of 30 items to be later summarized in 5 functional scales, 3 symptom scales, 6 single items and a global health status scale. All of the scores are standardized using linear transformation and converted onto a 0-100 scale. Thus, a higher score for a functional scale and the global health status scale mean a high level of functioning/quality of life. Conversely, a high score for a symptom scale/item means a worse quality of life due to the symptoms perceived.
Measured: Up to 12 months
Recurrence
Patients were re-evaluated 1, 3, 6, 9 and 12 months after surgery and every 6 months thereafter. Whole body CT scan and inguinal ultrasonography were performed every six months. Local, in-transit, regional and distant recurrences were recorded.
Number of patients with histology confirmed local recurrence
Measured: Up to 12 months
Number of excised lymph nodes
Information extracted from pathology report. Implications for quality assurance monitoring.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startSep 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508909
- Sponsor's protocol ID
- VIDEO SIIO trial, 2011/41
- Status last verified
- Jul 2015
- First submitted
- 16 Jul 2015
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sommariva A, Pasquali S, Rossi CR. Video endoscopic inguinal lymphadenectomy for lymph node metastasis from solid tumors. Eur J Surg Oncol. 2015 Mar;41(3):274-81. doi: 10.1016/j.ejso.2014.10.064. Epub 2014 Dec 27.
PubMed 25583458Martin BM, Etra JW, Russell MC, Rizzo M, Kooby DA, Staley CA, Master VA, Delman KA. Oncologic outcomes of patients undergoing videoscopic inguinal lymphadenectomy for metastatic melanoma. J Am Coll Surg. 2014 Apr;218(4):620-6. doi: 10.1016/j.jamcollsurg.2013.12.016. Epub 2013 Dec 24.
PubMed 24560569
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videoscopic Ilioinguinal Lymphadenectomy for Groin Lymph Node Metastases From Melanoma
- ClinicalTrials.gov ID
- NCT02508909
- Acronym / sponsor ID
- VIDEO SIIO trial, 2011/41
- Keywords
- Videoassisted surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 27 Jul 2015 (estimated)
- 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.
Groin lymph node dissection for melanoma patients is burdened by high post-operative morbidity, mainly related to wound. This is a prospective pilot trial investigated feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in patients with inguinal lymph node melanoma metastases.
Detailed description
Videoscopic ilioinguinal dissection is a two-stage procedure. Dissection is performed using an ultrasound dissector. The inguinal step is performed via three ports (one 3-5 cm above the apex of the femoral triangle, a second 5 cm medial to the adductors, and the third 5 cm lateral to the Sartorius muscle). After subcutaneous inflation, a formal inguinal lymph node (LN) dissection is performed, removing the contents of the femoral triangle, with incision and removal of the femoral fascia and proximal and distal ligation of the saphenous vein with vascular endostaplers and endoclips. The specimen is extracted using an endobag from the incision of SLNB, which is systematically removed, or through a small enlargement of the incision of the apex trocar for patients with clinically positive LNs. The iliac step starts with open insertion in the pro-peritoneal space of a Hasson trocar, followed by positioning of two additional trocars (5 and 10 mm respectively) just laterally of the umbilical pubic line. After creation of pneumo-pelvis, the iliac femoral vessels are identified, isolated and all the external iliac LNs removed. Afterwards, the obturator LNs are dissected off the obturator nerve. LNs are retrieved with an endobag or directly through the 10mm trocar after insertion of protective endotrocar. Two drains are positioned at the end of procedure in the obturator fossa and in the inguinal space, respectively. Intra-operative and early post-operative outcome (lenght of stay, complications, number of LNs) is recorded. Follow-up consists in detection of any recurrence, measurement of lymphedema of the leg and evaluation of quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Videoscopic ilioinguinal lymphadenectomy for melanoma | Experimental | Procedure: Videoscopic ilioinguinal dissectionMelanoma groin lymph node metastasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Melanoma patients without distant metastasis and either positive SLNB or clinically positive inguinal lymph nodes
Key exclusion criteria (1 listed)
- American Society of Anaesthesiologists (ASA) classification III-IV Severe chronic obstructive pulmonary disease (COPD) and other restrictive lung disease, Severe ischemic heart disease and chronic heart failure Previous cerebral abnormalities (aneurysm/arteriovenous malformations, ischemic/hemorrhagic stroke, primary or secondary tumors), History of deep vein thrombosis (DVT) Childbearing state Severe hip functional limitation Previous hip/knee arthroplasty. Previous surgery in the groin region (e.g., hernia repair, great saphenous vein surgery, iliac-femoral bypass) was considered a contraindication only for the iliac stage of lymphadenectomy.
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 |
|---|---|---|
| Videoscopic ilioinguinal dissectionAlso: Videoscopic groin lymphadenectomyInguinal dissection is performed after subcutaneous inflation via three ports. Iliac dissection is obtained through a pro-peritoneal access. | Procedure or surgery | Videoscopic ilioinguinal lymphadenectomy for melanoma |
Primary outcome
Operative complications
Time frame: 30 days
Frequency, type and severity of operative complications according to the Clavien-Dindo classification. Grade I: no intervention required; Grade II: medical therapy resolved the complication; Grade III A: intervention without general anaesthesia; Grade III B: intervention under general anaesthesia.
4 secondary outcomes
Leg lymphedema
Time frame: Up to 12 months
Quality of life
Time frame: Up to 12 months
Recurrence
Time frame: Up to 12 months
Number of excised lymph nodes
Time frame: 30 days
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 27 Jul 2015.
- Background: PubMed 25583458Sommariva A, Pasquali S, Rossi CR. Video endoscopic inguinal lymphadenectomy for lymph node metastasis from solid tumors. Eur J Surg Oncol. 2015 Mar;41(3):274-81. doi: 10.1016/j.ejso.2014.10.064. Epub 2014 Dec 27.
- Background: PubMed 24560569Martin BM, Etra JW, Russell MC, Rizzo M, Kooby DA, Staley CA, Master VA, Delman KA. Oncologic outcomes of patients undergoing videoscopic inguinal lymphadenectomy for metastatic melanoma. J Am Coll Surg. 2014 Apr;218(4):620-6. doi: 10.1016/j.jamcollsurg.2013.12.016. Epub 2013 Dec 24.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Videoscopic ilioinguinal dissection in people with Melanoma and Secondary Malignant Neoplasm of Lymph Node, run by Istituto Oncologico Veneto IRCCS.
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 1 inclusion and 1 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 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Operative complications (time frame: 30 days). 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 NCT02508909, which also lists 2 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 27 Jul 2015.