CompletedPhase 2ACTRN12617000132347

The EXCISE Study - EXcisional treatment Comparison for In Situ Endocervical adenocarinoma

Excisional treatment in women with cervical adenocarcinoma-in-situ (AIS): a prospective randomised controlled non-inferiority trial to compare AIS persistence/recurrence after loop electrosurgical excision procedure to cold knife cone biopsy.


Sponsor

St John of God Hospital, Subiaco WA 6008

Enrollment

40 participants

Start Date

Aug 2, 2017

Study Type

Interventional

Conditions

Summary

The aim of this pilot study is to compare loop electrosurgical excision procedure to cold knife cone biopsy for treatment of adenocarcinoma in situ. Who is it for? You may be eligible to join this study if you are a woman aged between 18 and 45 years old and have been diagnosed with adenocarcinoma in situ (AIS) with lesions amenable to single pass excision. Study details AIS most frequently occurs in young women (less than 45 years of age) who may wish to preserve their fertility. If this is the case, there are two treatment options available: cold knife cone (CKC) biopsy or loop electrosurgical excisional procedure (LEEP). In Australia, CKC is regarded as the 'gold standard' treatment for AIS. However, to date most AIS studies have been limited by small patient numbers and short follow-up periods. Further evidence is required to confirm if CKC is the superior treatment type for managing AIS. Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have their lesions removed using LEEP, whilst participants in the other group will have their lesions removed using CKC. Following treatment, all participants will undergo the 'Test of Cure' management pathway which includes follow-up examinations at 6 and 12 months post-treatment. Assessments for early complications and patient satisfaction will occur 6 weeks post-treatment. We are hoping to perform a pilot research study to confirm the safety and feasibility of conducting a much larger clinical trial which would be the first to compare CKC and LEEP in this way. Study findings could potentially improve patients' experiences and alter treatment guidelines since potential advantages of LEEP include the avoidance of general anaesthesia, provision of treatment in an outpatient setting, lower morbidity and reduced rates of obstetric complications.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria6

  • Aged between > = 18 to < = 45 years of age at time of study enrolment.
  • Documentation of AIS on cervical cytology and/or cervical biopsy test results.
  • Lesion amendable to single pass excision (serial endocervical excisions including 'top-
  • hat' will not be permitted in accordance with American Society for Colposcopy and
  • Cervical Pathology Recommendations.
  • Proficient in English

Exclusion Criteria9

  • High-grade cervical abnormality prior to current AIS diagnosis.
  • Previous excisional or ablative treatment (LEEP, CKC, Fisher cone biopsy, laser cone).
  • Cytology suspicious of invasion.
  • Clinical/colposcopic suspicion of invasion.
  • Presence of a concurrent gynaecological cancer.
  • Patients unable to comply with follow-up evaluations.
  • Immunosuppression.
  • Pregnancy.
  • Lesion considered unsuitable for single pass excision by treating specialist.

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Interventions

Eligible participants reported on screening cytology referred to a gynaecologist or gynaecological oncologist will be randomised to undergo a LEEP or CKC procedure. Participants randomised to the I

Eligible participants reported on screening cytology referred to a gynaecologist or gynaecological oncologist will be randomised to undergo a LEEP or CKC procedure. Participants randomised to the Intervention arm LEEP, will have their procedure performed either under local or general anaesthesia in an outpatient setting or operating theatre at the discretion of the treating specialist as per local routine practice. All participants will undergo endocervical curettage at the time of their LEEP or CKC. The approximate duration of the procedure is 15 - 30 minutes. Loop diathermy (LEEP) is the most commonly used treatment for high grade squamous dysplasia of the cervix in developed countries. The dimensions of the loop should be chosen after colposcopy preceding therapy to meet the width of the transformation zone and the planned type (length) of excision. Excisions are classified according to the length of cervix excised. Type I - usually to 8 mm and not more than 10 mm length of cervical tissue excised Type 2 - not more than 15 mm length of tissue excised Type 3 - equivalent to ‘cone biopsy’ and > 15 mm length In this Study only type 2 and 3 Excision are permitted. Diathermy settings should be significantly higher than used in most open or laparoscopic surgeries to reduce thermal artefact (this should be minimised to 0.2 mm). It is imperative that the clinician obtain the recommended power settings from the electrosurgical system manufacturer. It should be noted that each clinician will have a personal preference (to suit their surgical technique, loop size, speed of excision and other factors) that determine their personal ‘best settings’ for electrosurgical procedures. Extensive application of coagulation current should be avoided, especially at the endocervical margin, which rarely bleeds. A single pass of the loop (side to side or posterior to anterior) to produce a specimen in one piece is optimal. LEEP may be performed in an operating theatre, outpatient clinic or consulting rooms under local or general anaesthesia in accordance with local practice and at the discretion of the treating specialist. A cold knife cone biopsy uses a scalpel to excise a cone shaped piece of cervical tissue where the glandular abnormality (AIS) is located. The shape of the excision is not in reality a true cone, but a cone on top of a cylinder. The initial incision is perpendicular to the external cervical surface to ensure the excision of glands originally exposed in the post-menarche transformation zone now overlain by mature squamous metaplasia. Cone biopsies are type 3 excisions. The procedure is performed in an operating theatre under general anaesthesia by a gynaecological oncologist or gynaecologist with experience in the technique. All treating Investigators will be highly experienced providers and certified under the Colposcopy Quality Improvement Program (CQUIP) in accordance with the requirements of the Royal Australian and New Zealand College of Obstetrics and Gynaecology. Following treatment all patients will undergo the 'Test of Cure' management pathway. * Colposcopy and cervical cytology at 6 months' post excisional treatment * cervical cytology on oncongenic HPV typing at 12 month's post treatment and then annually in accordance with the revised NHMRC guidelines.


Locations(6)

St John of God Hospital, Subiaco - Subiaco

NSW,QLD,WA,VIC, Australia

The Royal Women's Hospital - Parkville

NSW,QLD,WA,VIC, Australia

King Edward Memorial Hospital - Subiaco

NSW,QLD,WA,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,WA,VIC, Australia

Mater Private Hospital - South Brisbane

NSW,QLD,WA,VIC, Australia

Auckland and Christchurch, New Zealand

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ACTRN12617000132347