Guidance

4. Colposcopic diagnosis, treatment and follow up

Updated 27 September 2024

1. Diagnostic standards for colposcopy

1.1 Availability of screening sample results

An individual’s screening sample results must be available to the colposcopist before the colposcopic examination begins.

1.2 Repetition of cervical screening sample

Cervical screening sampling should not be repeated at the first colposcopy following a referral for cytological abnormality or high risk human papillomavirus (hrHPV) positive and cytology negative result. Where an initial cytology sample is inadequate, the repeat cytology sample should be taken no less than 3 months after the date of the first sample.

1.3 Colposcopic examination

As indicated in the revised criteria for colposcopic examination from the International Federation of Cervical Pathology and Colposcopy (IFCPC) nomenclature committee in 2011, data recording at the colposcopic examination must include:

• the indication for referral
• the hrHPV result and grade of cytological abnormality
• the presence or absence of a cervix
• whether the examination was adequate or inadequate (for the examination to be adequate the entire cervix and squamo-columnar junction must be seen)
• the presence or absence of vaginal and or endocervical extension
• the colposcopic features of any lesion
• the colposcopic impression of lesion grade
• the type of transformation zone (type 1, 2 or 3)
• the site of any colposcopically directed biopsies

1.4 Invasive disease

Care must be taken not to overlook invasive disease. Excision is recommended (>95%):

• when most of the ectocervix is replaced with high grade abnormality
• when low grade colposcopic change is associated with high grade dyskaryosis (severe) or worse
• when a lesion extends into the endocervical canal, sufficient cervical tissue should be excised to remove the entire endocervical lesion
• where cytology is suggestive of invasive disease or of ?glandular neoplasia

In the situations mentioned above, punch biopsies are not considered to be reliably informative. The colposcopist should be aware of the small risk of inappropriate or inadvertent destruction of invasive or glandular lesions. These are most often encountered in association with high grade cytological or colposcopic change (CIN3). There may be pressing reasons for delaying excision (pregnancy for example). Reasons for not performing a biopsy must always be recorded.

1.5 Accuracy of colposcopic diagnosis

Colposcopy offers an accurate way to diagnose cervical intraepithelial neoplasia (CIN) and to differentiate high grade lesions from low grade abnormalities. The positive predictive value (PPV) of a colposcopic diagnosis is dependent on the prevalence of the disease in the referred population. According to research published in 2015, 2018 and 2019, the highest prevalence is found in individuals referred with a high grade cytology result, the lowest in individuals referred with persistent hrHPV and negative cytology.

PPV is defined as the proportion of individuals with an adequate colposcopic examination and a colposcopic impression (CI) of a high grade lesion who have high grade CIN (including cervical glandular intraepithelial neoplasia (CGIN)) or worse confirmed by histological examination (directed biopsy or tissue excised at first visit (see and treat)).

The PPV should be at least 75% for a CI of a high grade lesion (CIN2 or worse) for individuals referred with high grade cytology, and at least 35% for all other referrals.

1.6 Colposcopically directed punch biopsy

Unless an excisional treatment is planned, biopsy should be carried out when the cytology is high grade, and always when a recognisably atypical transformation zone is present. For cases occurring in pregnancy see chapter 4 (Management of cases relating to pregnancy, contraception, menopause and hysterectomy).

hrHPV positive and negative cytology or low grade cytological abnormality (low grade dyskaryosis or less) and a low grade or negative colposcopic examination do not necessarily require colposcopic biopsy.

Adequacy of biopsies

Of all biopsies taken (directed and excisional) ≥90% should be suitable for histological interpretation.

If colposcopically directed biopsy is reported as inadequate for histological interpretation, it should be repeated if there is a residual colposcopic lesion (≥95%).

2. Treatment of CIN

2.1 Indications for treatment

When deciding on treatment (and especially if destructive methods are being considered), associated cytological and colposcopic findings are as important as the result of directed biopsy. All individuals needing treatment must have had colposcopic assessment, and treatment must take place in properly equipped and staffed clinics. All treatment must be recorded in the colposcopy database and patient notes.

2.2 Surgical techniques

There is no obviously superior conservative surgical technique for treating and eradicating CIN, however research from 1991 and 2015 suggests that ablative techniques are only suitable when:

• the entire transformation zone is visualised
• there is no evidence of any glandular abnormality, including either ?glandular neoplasia or borderline changes in endocervical cells, on cytology
• there is no suspicion of any invasive disease
• there is no major discrepancy between cytology and histology
• there is no history of post-coital or intermenstrual bleeding
• there is no gland crypt involvement on punch biopsy
• there is no history of previous treatment

Only in exceptional circumstances should ablative treatment be considered for individuals over 50 years of age.

2.3 Local ablative techniques

All individuals must have an established histological diagnosis within the 3 months prior to having ablative treatment. This ensures that the cytology and histology can be correlated in advance to inform the decision on whether ablative treatment is suitable.

2.4 Cryocautery

Cryocautery should only be used for low grade CIN. A double freeze-thaw-freeze technique must be used.

2.5 Excision

Removal of specimen

When excision is used, at least 80% of cases should have the specimen removed as a single sample. Removing the transformation zone in multiple fragments can increase the difficulties encountered in histopathological assessment. Furthermore, if microinvasive disease is present, it may be impossible to allocate a sub-stage or define completeness of excision in fragmented excisional specimens.

Histology report

The histology report should record the dimensions of the specimen and the status of the resection with regard to intraepithelial or invasive disease. Cervical screening programme guidance for histopathology is available on GOV.UK.

Depth of excision

The goal of excision is to remove all the abnormal epithelium in accordance with the type of transformation zone.

Type I cervical transformation zone
For treating ectocervical lesions, excisional techniques should remove tissue to a depth of more than 7mm in ≥95% of cases, though the aim should be to remove <10mm in individuals of reproductive age

Type II cervical transformation zone
Excisional techniques should remove tissue to a depth of 10 to 15mm in ≥95% of cases, depending on the position of the squamocolumnar junction within the endocervical canal.

Type III cervical transformation zone
Excisional techniques should remove tissue to a depth of 15 to 25 mm in ≥95% of cases, depending on the position of the squamocolumnar junction within the endocervical canal.

For the management of individuals with CGIN, see section 3.2 below.

2.6 ‘See and treat’ policy

Clinics can offer treatment at first visit to colposcopy for a high grade referral.

Treatment at first visit to colposcopy for a referral of hrHPV positive and cytology negative, borderline squamous changes or low grade dyskaryosis should not be offered except where the abnormality is known to be long-standing.

It is inappropriate to adopt ‘see and treat’ if the proportion of specimens that do not show evidence of CIN is high. This is because many individuals would receive unnecessary treatment.

The proportion of individuals treated at the first visit who have evidence of CIN2, CIN3, or CGIN on histology must be ≥90%.

2.7 Treatment following diagnostic biopsy

Individuals with a diagnosis of high grade CIN must receive treatment promptly. The proportion of individuals offered definitive treatment for high grade CIN within 4 weeks of the colposcopy clinic receiving a diagnostic biopsy report should be ≥90%. The proportion of individuals treated within 4 weeks should be monitored and recorded. All individuals having definitive treatment for high grade CIN must be treated within 8 weeks with the exception of those who are pregnant.

2.8 Repeat excision

High grade CIN extending to margins

High grade CIN extending to the deep lateral or endocervical margins of excision (or uncertain margin status) results in a higher incidence of recurrence but does not justify routine repeat excision if:

• there is no evidence of glandular abnormality
• there is no evidence of invasive disease
• the individual is under 50 years of age

All individuals over the age of 50 years who have CIN3 at the deep lateral or endocervical margins, and in whom satisfactory screening samples and colposcopy cannot be guaranteed, must have a repeat excision performed to try to obtain clear margins.

Individuals under the age of 50 years of age with HG CIN (CIN2+) on LLETZ or loop specimens at the deep lateral and, or endocervical canal margin do not need to have extra levels or the end blocks turned to assess excisional completion.

Individuals over the age of 50 years of age with potential deep lateral and, or endocervical canal margin involvement by HG CIN (CIN2+) should have levels and, or end blocks turned to allow a definitive statement about the adequacy of excision of HG CIN at these margins.

Individuals of any age with evidence of a glandular abnormality or invasive disease do require this extra work if necessary, to allow for a definitive comment on the adequacy of excision at these margins.

For individuals under the age of 50 years, if the need for margin status should be required for on-going clinical management then this should be discussed at the MDT.

2.9 Local excision of microinvasive squamous cancer FIGO stage Ia1

Microinvasive squamous cancer International Federation of Gynaecology and Obstetrics (FIGO) stage Ia1 can be managed by local excisional techniques if:

• the endocervical and deep lateral excision margins are free of both CIN and invasive disease (re-excision is not required when only the ectocervical margin is involved with CIN)
• the gynaecological cancer centre pathologist and multidisciplinary team (MDT) have reviewed the histology

If the invasive lesion is excised but CIN extends only to the deep lateral and endocervical excision margin, then a repeat excision should be performed to confirm complete excision of the CIN and to exclude further invasive disease.

2.10 Anaesthesia

Treatment should be performed with adequate pain control and should include pre-treatment counselling. Treatment should be offered with local analgesia. Where this is inappropriate, general anaesthesia should be offered. Reasons for treating under general anaesthesia should be recorded in the colposcopy record. The proportion of individuals managed as out-patients with local anaesthesia should be at least 85%, with an achievable target of 90%.

3. Management of glandular abnormalities

3.1 Cervical glandular intraepithelial abnormalities

Cervical screening with hrHPV can predict the presence of cervical glandular intraepithelial abnormalities.

3.2 Reporting of glandular abnormalities on cytology

Written reports

Report samples as ?glandular neoplasia of endocervical type if they show cytological features suggestive of cervical glandular intraepithelial neoplasia (CGIN) or endocervical adenocarcinoma.

Borderline changes in endocervical cell samples

Individuals who have a positive primary hrHPV test and subsequently have a borderline endocervical screening result should be referred to colposcopy and have appropriate assessment. At least 93% of referrals should be seen within 2 weeks.

Individuals referred with borderline changes in endocervical cells with a negative colposcopic examination should not be given a 3 year recall but considered at MDT. They are likely to be followed up at 6 months with screening or in the colposcopy clinic. They will only be discharged to 3 year recall if the cytology is downgraded to negative at MDT.

?Glandular neoplasia of endocervical type

Refer patients to colposcopy for further investigation. At least 93% of patients should be seen within 2 weeks of referral.

?Glandular neoplasia (non-cervical)

Refer patients to gynaecology for further investigation. At least 93% of patients should be seen within 2 weeks of referral.

The role of colposcopically directed or punch biopsy in the management of

?glandular neoplasia and borderline changes in endocervical cells samples

Punch biopsy in the management of ?glandular neoplasia and borderline changes in endocervical cell samples is not appropriate. Investigate and diagnose CGIN/stratified mucin producing intraepithelial lesion of the cervix (SMILE) through colposcopy and histopathological assessment of an excisional biopsy (including the endocervical canal) in order to distinguish between CGIN and invasive adenocarcinoma.

Endometrial biopsy

Endometrial sampling is indicated in individuals referred to colposcopy with ?glandular neoplasia or not otherwise specified (NOS).

Endocervical curettage in the assessment of ?glandular neoplasia of endocervical type

There is no clear role for endocervical curettage in the assessment of ?glandular neoplasia of endocervical type therefore the programme does not recommend this.

3.3 Clinical management of cervical glandular intraepithelial neoplasia

Management of cytology reported as ?glandular neoplasia of endocervical type (CGIN)

For individuals with suspected CGIN or early invasive adenocarcinoma, the extent of the cervical excision should be tailored to each case. In younger individuals and or individuals who wish to conserve their fertility who have a colposcopically visible squamocolumnar junction (SCJ), a cylindrically-shaped cervical excisional biopsy including the whole transformation zone (TZ) and at least 10mm of endocervix above the SCJ is appropriate.

In older individuals (age 50 or over), or where the SCJ is not visible at colposcopy, a cylindrical biopsy should be taken that includes all of the visible TZ and 20mm to 25mm of the endocervical canal.

All cases of CGIN must be discussed at the colposcopy MDT meeting.

Management of confirmed CGIN

CGIN often occurs in young individuals. Excisional treatment is recommended for those wishing to retain fertility. Individuals can be managed conservatively if, following excisional treatment, the margins of the excisional specimen are negative and invasion is excluded. They should be counselled that the expected programme of management appears safe as long as follow up tests and appointments are attended.

Management of incompletely excised CGIN

If the margins of an initial excision are not free from CGIN, a further attempt at excision should be offered in order to confidently exclude invasion and obtain negative margins. For individuals who decline a repeat excision or if a repeat excision is not possible, primary hrHPV testing should be performed 6 months after treatment. If negative, it should be repeated 6 months later (12 months after treatment), and then annually for the subsequent 9 years. If hrHPV test is positive at any point in follow up and the sample was performed in the community, a direct referral to colposcopy is required regardless of the cytology result, or because of persisting HPV positivity and negative cytology.

The colposcopy MDT should help to guide any further management.

Follow up of treated CGIN

Individuals who undergo excision for CGIN are at risk of recurrence. If the CGIN has been completely excised at the time of first excision or subsequent re-excision, a test of cure (TOC) sample should be taken 6 months after treatment. If negative for hrHPV a second TOC sample is taken 12 months later (18 months after treatment or the subsequent re-excision). If this is also negative for hrHPV the individual can be recalled for screening in 3 years. These samples can be performed in the community.

If at 6 or 18 months after treatment the test is positive for hrHPV the individual should be referred to colposcopy. A reflex cytology sample is processed to help inform colposcopy.

If an individual fails TOC at 6 months only because of a positive hrHPV test, cytology is negative or inadequate and no abnormality is detected at colposcopic examination, they should have a second TOC sample 12 months later. If this sample is hrHPV negative the individual can be discharged to recall in 3 years. Further recall will depend on the result of this test and the age of individual.

If a positive hrHPV test with abnormal cytology is reported in either of the 6 or 18 month TOC samples, the individual must be referred to colposcopy for management. If no colposcopic abnormality is present and re-excision is not appropriate, the individual should revert to 10 years of follow up with annual hrHPV testing.

3.4 Stratified mucin producing intraepithelial lesion of the cervix (SMILE)

SMILE is a histological entity usually found in conjunction with CIN and CGIN, but it can occur in the absence of these. The cytological appearance of SMILE is poorly understood. Individuals with SMILE should be managed according to guidance for CGIN.

3.5 Hysterectomy for cervical glandular neoplasia

Simple hysterectomy may be considered if:

• fertility is not required
• there are positive margins after an adequate excisional procedure
• treatment by excision is followed by further high grade cytological abnormality
• the patient is unwilling to undergo conservative management
• adequate screening follow up has not been possible, for example because of cervical stenosis
• the patient has other clinical indications for the procedure
• invasive disease has been confidently excluded

4. Follow up of individuals attending for colposcopy with CIN and early stage cervical cancer

4.1 Treated individuals

All individuals remain at risk following treatment and must be followed up 6 months after treatment according to screening guidance as given below. Treated individuals are between 2 and 5 times more likely than the general population to experience cervical cancer. Much of this increased risk may result from poor compliance with long term follow up. Patient compliance with follow up must be encouraged.

The proportion of histological treatment failures should not exceed 5% within 12 months of treatment.

4.2 Duration and frequency of follow up after treatment for CIN under the HPV test of cure protocol

Individuals who have been treated for CIN1, CIN2, or CIN3 should be invited 6 months after treatment for a test of cure repeat cervical sample in the community. The date for the next recall should be 6 months after their treatment. The colposcopy clinic is responsible for notifying the call and recall service with the due date for the next screen.

Patient compliance with follow up must be encouraged. The nature and timing of follow up depends on their screening result, that is:

• individuals with a sample that has been reported as hrHPV negative should be recalled in 3 years, whatever their age; where the 3 year test is negative, individuals can return to routine recall
• individuals with a sample that has been reported as positive for hrHPV should be referred to colposcopy; reflex cytology is performed as it helps to inform colposcopic examination
• individuals whose hrHPV result is unavailable should have repeat testing at 3 months
• individuals who reach the age of 65 must continue to be invited for follow up tests and or be referred for further investigations as necessary until they have completed all follow up protocols and satisfy the requirements for being ceased from the programme

4.3 Cervical sampling equipment for follow up testing

The Cervex brush is approved for use in the cervical screening programme. Sample takers may take an additional endocervical sample using an endocervical brush in limited circumstances, as described in Guidance for the training of cervical sample takers.

4.4 Management for individuals following treatment for early stage cervical cancer

The treatment of early invasive cervical cancer lies outside the responsibility of the NHS Cervical Screening Programme (NHS CSP). However the guidance below is provided for the sake of completeness and details the programme follow up recall requirements.

Follow up of stage Ia1

If conservative treatment for cervical cancer has been performed, leaving a residual cervix, follow up is recommended. A TOC primary hrHPV sample should be taken 6 and 12 months after treatment, followed by annual sampling for the next 9 years before returning to routine recall (if still within the screening age range). The cervical screening programme continues to provide recall arrangements.

If at any point in follow up a sample performed in the community is hrHPV positive, a direct referral to colposcopy is required regardless of the cytology result.

Follow up of stage Ia2/Ib1

If conservative management for Ia2/Ib1 disease was by simple or radical trachelectomy, follow up is determined by the management policy of the gynaecological oncologist.

If the individual has undergone total hysterectomy for early stage cervical cancer, follow up will be in accordance with local cancer network guidelines. The individual is ceased from the cervical screening programme. Individuals who receive pelvic radiotherapy either as primary or adjuvant treatment are also followed up according to local cancer network guidelines and ceased from cervical screening.

4.5 Follow up after simple hysterectomy

Vault sampling is not part of the routine screening programme. Individuals who have had a hysterectomy with CIN present are potentially at risk of developing vaginal intraepithelial neoplasia (VaIN) and invasive vaginal disease. There is no clear evidence that colposcopy increases the detection of disease on follow up. Responsibility for implementing follow up policies rests with the treating gynaecologist and will be informed by the local lead colposcopist.

The recommended follow up is that:

• for individuals on routine recall and with no CIN in their hysterectomy specimen, no further vaginal vault sample is required
• individuals who undergo hysterectomy and have completely excised CIN should have vaginal vault sample at 6 months following their hysterectomy; if they have a negative HPV result they can be discharged
• individuals who undergo hysterectomy and have completely excised CIN, and are hrHPV positive cytology negative at 6 months, should be referred to colposcopy; if there is no evidence of VaIN at colposcopy the individual can be discharged
• for individuals who undergo hysterectomy and have incompletely excised CIN (or uncertain excision), primary HPV screening follow up should be
  • CIN 1: vault sample at 6, 12 and 24 months
  • CIN 2/3: vault samples at 6 and 12 months followed by 9 annual vault samples
  • follow up for incompletely excised CIN continues to 65 years or until 10 years after surgery (whichever is later)
• any gynaecologist discharging a patient who requires further vault samples should ensure that the GP receives clear written guidance for follow up
• the clinician in charge (gynaecologist or GP) is responsible for failsafe mechanisms for this small group of individuals
• individuals who undergo subtotal hysterectomy still have their cervix in situ, and so must remain within the cervical screening programme

In addition, individuals who have radical trachelectomy as part of conservative management of cervical cancer should remain under the care and guidance of their treating gynaecologist or gynaecological oncologist. Follow up is recommended with colposcopy and hrHPV testing. Owing to the limited information on outcome however, all cases should be subject to local audit. These individuals are under the individual care of a gynaecologist and are no longer within the cervical screening programme. Therefore local commissioning arrangements need to be put in place.

4.6 Follow up of untreated individuals

Individuals referred with high grade dyskaryosis (moderate or severe)

Individuals referred with high grade dyskaryosis (moderate or severe) on their test result are at significant risk of CIN 2 or 3, even if colposcopy was normal. Biopsy should be undertaken in ≥95% of individuals with high grade dyskaryosis (moderate or severe) on their test result. If there is no CIN or low grade CIN on the biopsy these cases should be discussed at the MDT. If no treatment is carried out, close surveillance with colposcopy and cervical samples every 6 months is advised. If at follow up there is persistent high grade cytology, or CIN2 or CIN3 is present on biopsy, excisional treatment is recommended (≥90%). Conservative management of CIN2 is described below.

Individuals referred with high grade dyskaryosis on their test result who have a colposcopically low grade lesion, whose colposcopy is adequate and who are not treated, should have multiple biopsies (≥90%). If CIN 1 or less is confirmed, colposcopic and cervical sample follow up at 6 months is advised. If the repeat sample is negative for hrHPV they should have repeat testing at 36 months.

Cases with unexplained high grade dyskaryosis should be discussed at MDT meetings.

Individuals referred with low grade cytology

Individuals referred with low grade dyskaryosis or less and who have an adequate and normal colposcopic examination are at low risk of developing cervical cancer. These individuals are returned to community-based 3 year recall.

Individuals referred with a result of low grade dyskaryosis or less and who have a colposcopically low grade CIN1 or biopsy proven CIN1 should have a further screen at 12 months in the community.

Colposcopic biopsy at initial assessment is not essential to confirm or exclude low grade CIN.

If the lesion has not resolved within 2 years of referral to colposcopy, a biopsy should be considered. Persistent low grade CIN is not considered to be a significant precursor to high grade disease and women can be offered further annual surveillance. Women can be offered treatment at this point as persistent surveillance risks default and women might prefer this option. Options should be discussed with women and informed choice documented. Excisional treatments in this setting are not expected to contain high grade disease and should be excluded from audits of high grade cytology management pathways.

Women with persistent HPV with no evidence of disease at colposcopy should not be offered treatment.

4.7 Conservative management of CIN2

Individuals can be offered conservative management of CIN2 if:

• the colposcopic examination is adequate and has excluded CIN3 and an invasive lesion
• a CIN2 lesion occupies no more than 2 quadrants of the cervix
• CIN2 has been diagnosed on histology and reviewed at MDT to exclude an undercall or overcall
• they agree to regular 6 monthly follow up colposcopic examinations including repeat cervical sampling and repeat biopsy (if indicated by the presence of a more severe lesion (CIN3) on colposcopic examination)
• they understand the time period for resolution of CIN2 can be at least 24 months (as described in research published in 1993, 2017 and 2018

Treatment must be offered if the CIN2 has not resolved within 24 months.

All cases must be discussed by the MDT to ratify a decision for conservative management. Outcomes should be subject to regular local audit.