A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD)
Abstract Background Penile cancer is a rare male genital malignancy. Surgical excision of the primary tumour is followed by radical inguinal lymphadenectomy if there is metastatic disease detected by biopsy, fine needle aspiration cytology (FNAC) or following sentinel lymph node biopsy in patients w...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2024-04-01
|
| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-024-01474-8 |
| _version_ | 1797209584310419456 |
|---|---|
| author | Stanley Tang Clare Akers Hussain Alnajjar Ben Ayres Cinzia Baldini Andrew Embleton-Thirsk Kurinchi Gurusamy Paul Hadway Vivekanandan Kumar Maurice Lau Raj Nigam Karl Pang Arie Parnham Elena Pizzo Veronica Ranieri Rowland Rees Vijay Sangar Anvi Wadke Norman Williams Asif Muneer |
| author_facet | Stanley Tang Clare Akers Hussain Alnajjar Ben Ayres Cinzia Baldini Andrew Embleton-Thirsk Kurinchi Gurusamy Paul Hadway Vivekanandan Kumar Maurice Lau Raj Nigam Karl Pang Arie Parnham Elena Pizzo Veronica Ranieri Rowland Rees Vijay Sangar Anvi Wadke Norman Williams Asif Muneer |
| author_sort | Stanley Tang |
| collection | DOAJ |
| description | Abstract Background Penile cancer is a rare male genital malignancy. Surgical excision of the primary tumour is followed by radical inguinal lymphadenectomy if there is metastatic disease detected by biopsy, fine needle aspiration cytology (FNAC) or following sentinel lymph node biopsy in patients with impalpable disease. However, radical inguinal lymphadenectomy is associated with a high morbidity rate, and there is increasing usage of a videoendoscopic approach as an alternative. Methods A pragmatic, UK-wide multicentre feasibility randomised controlled trial (RCT), comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy. Patients will be identified and recruited from supraregional multi-disciplinary team meetings (sMDT) and must be aged 18 or over requiring inguinal lymphadenectomy, with no contraindications to surgical intervention for their cancer. Participants will be followed up for 6 months following randomisation. The primary outcome is the ability to recruit patients for randomisation across all selected sites and the rate of loss to follow-up. Other outcomes include acceptability of the trial and intervention to patients and healthcare professionals assessed by qualitative research and obtaining resource utilisation information for health economic analysis. Discussion There are currently no other published RCTs comparing videoendoscopic versus open radical inguinal lymphadenectomy. Ongoing study is required to determine whether randomising patients to either procedure is feasible and acceptable to patients. The results of this study may determine the design of a subsequent trial. Trial registration Clinicaltrials.gov PRS registry, registration number NCT05592639. Date of registration: 13th October 2022, retrospectively registered |
| first_indexed | 2024-04-24T09:57:01Z |
| format | Article |
| id | doaj.art-ca6c797ba772425e9cc52b9dca343a83 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-04-24T09:57:01Z |
| publishDate | 2024-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-ca6c797ba772425e9cc52b9dca343a832024-04-14T11:08:08ZengBMCPilot and Feasibility Studies2055-57842024-04-011011710.1186/s40814-024-01474-8A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD)Stanley Tang0Clare Akers1Hussain Alnajjar2Ben Ayres3Cinzia Baldini4Andrew Embleton-Thirsk5Kurinchi Gurusamy6Paul Hadway7Vivekanandan Kumar8Maurice Lau9Raj Nigam10Karl Pang11Arie Parnham12Elena Pizzo13Veronica Ranieri14Rowland Rees15Vijay Sangar16Anvi Wadke17Norman Williams18Asif Muneer19University College London Hospitals NHS TrustUniversity College London Hospitals NHS TrustUniversity College London Hospitals NHS TrustSt George’s University Hospitals NHS TrustUniversity College LondonUniversity College LondonUniversity College LondonRoyal Berkshire NHS Foundation TrustNorfolk and Norwich University Hospitals NHS Foundation TrustThe Christie NHS Foundation TrustRoyal Surrey County HospitalUniversity College London Hospitals NHS TrustThe Christie NHS Foundation TrustUniversity College LondonUniversity College LondonUniversity Hospital Southampton NHS Foundation TrustThe Christie NHS Foundation TrustUniversity College LondonUniversity College LondonUniversity College London Hospitals NHS TrustAbstract Background Penile cancer is a rare male genital malignancy. Surgical excision of the primary tumour is followed by radical inguinal lymphadenectomy if there is metastatic disease detected by biopsy, fine needle aspiration cytology (FNAC) or following sentinel lymph node biopsy in patients with impalpable disease. However, radical inguinal lymphadenectomy is associated with a high morbidity rate, and there is increasing usage of a videoendoscopic approach as an alternative. Methods A pragmatic, UK-wide multicentre feasibility randomised controlled trial (RCT), comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy. Patients will be identified and recruited from supraregional multi-disciplinary team meetings (sMDT) and must be aged 18 or over requiring inguinal lymphadenectomy, with no contraindications to surgical intervention for their cancer. Participants will be followed up for 6 months following randomisation. The primary outcome is the ability to recruit patients for randomisation across all selected sites and the rate of loss to follow-up. Other outcomes include acceptability of the trial and intervention to patients and healthcare professionals assessed by qualitative research and obtaining resource utilisation information for health economic analysis. Discussion There are currently no other published RCTs comparing videoendoscopic versus open radical inguinal lymphadenectomy. Ongoing study is required to determine whether randomising patients to either procedure is feasible and acceptable to patients. The results of this study may determine the design of a subsequent trial. Trial registration Clinicaltrials.gov PRS registry, registration number NCT05592639. Date of registration: 13th October 2022, retrospectively registeredhttps://doi.org/10.1186/s40814-024-01474-8Penile cancerLymphadenectomySquamous cell carcinomaMelanoma |
| spellingShingle | Stanley Tang Clare Akers Hussain Alnajjar Ben Ayres Cinzia Baldini Andrew Embleton-Thirsk Kurinchi Gurusamy Paul Hadway Vivekanandan Kumar Maurice Lau Raj Nigam Karl Pang Arie Parnham Elena Pizzo Veronica Ranieri Rowland Rees Vijay Sangar Anvi Wadke Norman Williams Asif Muneer A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD) Pilot and Feasibility Studies Penile cancer Lymphadenectomy Squamous cell carcinoma Melanoma |
| title | A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD) |
| title_full | A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD) |
| title_fullStr | A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD) |
| title_full_unstemmed | A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD) |
| title_short | A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD) |
| title_sort | study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer velrad |
| topic | Penile cancer Lymphadenectomy Squamous cell carcinoma Melanoma |
| url | https://doi.org/10.1186/s40814-024-01474-8 |
| work_keys_str_mv | AT stanleytang astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT clareakers astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT hussainalnajjar astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT benayres astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT cinziabaldini astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT andrewembletonthirsk astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT kurinchigurusamy astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT paulhadway astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT vivekanandankumar astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT mauricelau astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT rajnigam astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT karlpang astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT arieparnham astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT elenapizzo astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT veronicaranieri astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT rowlandrees astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT vijaysangar astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT anviwadke astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT normanwilliams astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT asifmuneer astudyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT stanleytang studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT clareakers studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT hussainalnajjar studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT benayres studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT cinziabaldini studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT andrewembletonthirsk studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT kurinchigurusamy studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT paulhadway studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT vivekanandankumar studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT mauricelau studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT rajnigam studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT karlpang studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT arieparnham studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT elenapizzo studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT veronicaranieri studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT rowlandrees studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT vijaysangar studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT anviwadke studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT normanwilliams studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad AT asifmuneer studyprotocolforafeasibilityrandomisedcontrolledtrialinvestigatingvideoendoscopicradicalinguinallymphadenectomyversusopenradicalinguinallymphadenectomyinpatientswithpenilecancervelrad |