Clinical trial · Interventional
Haemorrhage Risk Reduction Using Endovascular Embolisation in Place of Vessel Ligation for Patients Undergoing Transoral Robotic Surgery (HELPR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Transoral robotic surgery (TORS )has been shown to offer excellent oncological and functional outcomes for treating cancer at multiple subsites of the head and neck. Post operative haemorrhage (3.1% to 13.1%) is the most common complication of this procedure and can lead to airway compromise. Ligation of individual feeding vessels in the neck can limit risk of severe bleed and is usually done when concomitant neck dissection is carried out with TORS. In salvage TORS, in the absence of any nodal disease of the neck, the neck is explored, nevertheless, for the sole purpose of tying the vessel. Endovascular embolisation is a minimally invasive, safe and effective procedure; known for treating refractory epistaxis and for reducing intra-operative bleeding for benign vascular head and neck tumour. The investigators propose that superselective endovascular embolisation to occlude feeding blood vessels prior to TORS in patients who do not require neck dissection is a feasible, safe and acceptable intervention; and therefore a plausible alternative conventional open neck vessel ligation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endovascular embolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endovascular embolisation
- description
- Embolisation is an effective measure to reduce intraoperative bleeding for vascular tumours of the head and neck. It is often carried out from 24 to 72 hours prior to the surgical resection to allow time for maximal thrombosis of the occluded vessels and prevent recanalisation of the occluded arteries or formation of collateral arterial channels. Data will be collected for primary and secondary outcome measures
- interventionNames
- Procedure: Endovascular embolization
Primary outcomes (2)
- measure
- Feasibility of embolisation procedure
- timeFrame
- Day 1 post the embolisation procedure
- description
- Measure by the calculating the proportion of successful completion of embolisation procedure out of the total number of patients eligible for the embolisation procedure.
- measure
- Feasibility of open neck vessel ligation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For Main Study: Inclusion Criteria * Residual, recurrent or new primary oropharyngeal, laryngeal or hypopharyngeal cancer, in a previously irradiated field. * Listed for TORS resection * Who would normally be indicated for concurrent ligation of branches of their external carotid artery for peri-operative haemorrhage control Exclusion Criteria * Patients requiring concurrent ipsilateral neck surgery alongside their TORS resection, who would be more suited to undergo surgical vessel ligation. * Patients known to have undergone previous ligation or embolisation of the ipsilateral external carotid artery or the relevant feeding branches. * Females who are pregnant * Females of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test * Females must not be breastfeeding. For Retrospective Sub-Study Inclusion Criteria * Residual, recurrent or new primary oropharyngeal, laryngeal or hypopharyngeal cancer, in a previously irradiated field * Who underwent TORS resection to manage this disease * Who had concurrent neck surgery for surgical ligation of branches of their external carotid artery for peri-operative haemorrhage control Exclusion Criteria \- Patients known to have undergone previous ligation or embolisation of the ipsilateral external carotid artery or the relevant feeding branches.
References
Publications (27)
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- BACKGROUNDD'Souza G, Kreimer AR, Viscidi R, Pawlita M, Fakhry C, Koch WM, Westra WH, Gillison ML. Case-control study of human papillomavirus and oropharyngeal cancer. N Engl J Med. 2007 May 10;356(19):1944-56. doi: 10.1056/NEJMoa065497. PMID 17494927
- BACKGROUNDAng KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7. PMID 20530316
- BACKGROUNDde Almeida JR, Byrd JK, Wu R, Stucken CL, Duvvuri U, Goldstein DP, Miles BA, Teng MS, Gupta V, Genden EM. A systematic review of transoral robotic surgery and radiotherapy for early oropharynx cancer: a systematic review. Laryngoscope. 2014 Sep;124(9):2096-102. doi: 10.1002/lary.24712. Epub 2014 May 27. PMID 24729006
- BACKGROUNDKelly K, Johnson-Obaseki S, Lumingu J, Corsten M. Oncologic, functional and surgical outcomes of primary Transoral Robotic Surgery for early squamous cell cancer of the oropharynx: a systematic review. Oral Oncol. 2014 Aug;50(8):696-703. doi: 10.1016/j.oraloncology.2014.04.005. Epub 2014 Jun 7. PMID 24917389
- BACKGROUNDHutcheson KA, Holsinger FC, Kupferman ME, Lewin JS. Functional outcomes after TORS for oropharyngeal cancer: a systematic review. Eur Arch Otorhinolaryngol. 2015 Feb;272(2):463-71. doi: 10.1007/s00405-014-2985-7. Epub 2014 Mar 19. PMID 24643851
- BACKGROUNDWeinstein GS, O'Malley BW Jr, Magnuson JS, Carroll WR, Olsen KD, Daio L, Moore EJ, Holsinger FC. Transoral robotic surgery: a multicenter study to assess feasibility, safety, and surgical margins. Laryngoscope. 2012 Aug;122(8):1701-7. doi: 10.1002/lary.23294. Epub 2012 Jul 2.