Haemorrhage Risk Reduction Using Endovascular Embolisation in Place of Vessel Ligation for Patients Undergoing Transoral Robotic Surgery (HELPR)

Head and Neck Cancer Clinical Trial

Official title:

Haemorrhage Risk Reduction Using Endovascular Embolisation in Place of Vessel Ligation for Patients Undergoing Transoral Robotic Surgery (HELPR)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05477992
• Other study ID #: CCR5262
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: November 2023

Study information

• Verified date: July 2022
• Source: Royal Marsden NHS Foundation Trust
• Contact: Trial Manager
• Phone: 02073528171
• Email: helpr.study[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The incidence of squamous cell carcinoma of oropharynx has increased at an alarming rate attributed to human papillomavirus (HPV).The prognosis of patients with HPV-associated oropharyngeal cancer is significantly improved, and as such, consideration of functional outcomes has become increasingly important. Transoral robotic surgery (TORS) has been shown to offer excellent oncological outcomes and low incidence of positive margins with promising functional outcome at multiple subsites of the head and neck. Like many oropharyngeal surgeries, bleeding is the most common complication after TORS. Postoperative oropharyngeal haemorrhage, particularly when severe, can lead to airway compromise, aspiration, asphyxiation, and cardiopulmonary arrest. Its incidence has been variable in literature, with rates ranging from 3.1% to 13.1%. It is an area of current interest because of the increasing adoption of TORS and the active recruitment to current multi-centre randomized controlled trials, such as ECOG 3311 (NCT01898494) and PATHOS. Ligation of the individual feeding vessels from the external carotid artery (e.g. ascending pharyngeal, lingual and facial branches) has shown to limit the risk of postoperative haemorrhage and is highly recommended. This is usually done when concomitant neck dissection is carried out with transoral resection. However, in the absence of any nodal disease, for instance in salvage TORS for recurrent oropharyngeal cancer, the neck is surgically explored for the sole purpose of tying the vessel. This is particularly more difficult surgically and carries a higher risk of failure in patients who had exposure to prior radiation where healing can be dramatically delayed. Embolisation, first described in 1974, is now a well-recognised treatment for refractory epistaxis and an effective measure to reduce intraoperative bleeding for vascular tumours of the head and neck. The latter 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 recanalization of the occluded arteries or formation of collateral arterial channels. This procedure has been proven to be minimally invasive, safe and effective in controlling haemorrhage even in cases of acute carotid blowout syndrome. The targeted vessels for embolisation are also branches of the external carotid artery, of similar calibre and size to the feeding vessels which are ligated in TORS. Although endovascular embolisation of branches of external carotid artery has not been carried out for the purpose of TORS in the past, it has been highly successful in controlling of bleeding in the case of benign vascular tumours of head and head. The investigators propose that this standard endovascular embolisation can also be applied to patient undergoing TORS who do not require neck dissection. The investigators believe that this is a feasible, safe and acceptable intervention and a plausible alternative to conventional open neck vessel ligation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Hemorrhage

Intervention

Procedure:
• Endovascular embolization
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

References & Publications (27)

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Gleysteen J, Troob S, Light T, Brickman D, Clayburgh D, Andersen P, Gross N. The impact of prophylactic external carotid artery ligation on postoperative bleeding after transoral robotic surgery (TORS) for oropharyngeal squamous cell carcinoma. Oral Oncol. 2017 Jul;70:1-6. doi: 10.1016/j.oraloncology.2017.04.014. Epub 2017 May 9. — View Citation

Hay A, Migliacci J, Karassawa Zanoni D, Boyle JO, Singh B, Wong RJ, Patel SG, Ganly I. Haemorrhage following transoral robotic surgery. Clin Otolaryngol. 2018 Apr;43(2):638-644. doi: 10.1111/coa.13041. Epub 2017 Dec 26. — View Citation

Hutcheson 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. Review. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of embolisation procedure	Measure by the calculating the proportion of successful completion of embolisation procedure out of the total number of patients eligible for the embolisation procedure.	Day 1 post the embolisation procedure
Primary	Feasibility of open neck vessel ligation	Measure by the calculating the proportion of successful completion of open neck vessel ligation procedure out of the total number of patients who undergo this procedure.	Day 1 post open neck vessel ligation
Secondary	Safety of embolisation procedure	Measured by calculating the proportion of major or minor adverse event sites out of all patients who undergo embolisation	Day 30 post embolisation procedure
Secondary	Efficacy of embolisation procedure	Measured by calculating the proportion of post-operative bleeding from the primary site in all patients who undergo embolisation	Day 30 post embolisation procedure
Secondary	Acceptability of embolisation procedure	Qualitative methods only, therefore no quantitative endpoint	After day 30 post procedure, at the time of focus group discussion
Secondary	Safety of open neck vessel ligation	Measured by calculating the proportion of major or minor adverse event sites out of all patients who undergo open neck vessel ligation	Day 30 post open neck vessel ligation
Secondary	Efficacy of open neck vessel ligation	Measured by calculating the proportion of major or minor adverse event sites out of all patients who undergo open neck vessel ligation	Day 30 post open neck vessel ligation