Background

The landscape of small bowel investigation has shifted dramatically in the last 14 years following the introduction of capsule endoscopy (CE) and device-assisted enteroscopy (DAE). Previously difficult to access due to anatomy, length and tortuosity, direct visualisation of the small bowel mucosa can now be achieved non-invasively with CE, while histological examination and therapy of abnormalities deep within the small bowel is possible using DAE. CE examination is now well established as an investigative modality for obscure gastrointestinal (GI) bleeding, iron-deficiency anaemia, Crohn's disease, coeliac disease and familial polyposis syndromes.1–5

CE is relatively simple to perform, and without clear definitions of competence to practice, a CE service can be initiated with relatively little time or financial investment. Consequently, widespread use and rising demand has meant services have developed in an organic fashion, led by local interest and initiative rather than in a planned, strategic manner. In contrast, DAE is a difficult and time-consuming procedure requiring specialised equipment, infrastructure and training and therefore remains predominantly the domain of tertiary centres.6 This article describes aspects of service provision, delivery and training and discusses appropriate quality service indicators.

Demand for small bowel endoscopy

When considering development of small bowel services, it is important to think about demand both from the UK national and local perspective. In a survey published in 2012, 91% of UK gastroenterologists referred for CE with 45% referring to local services within their own trust.7 Despite the number of CE per centre growing year on year, only two regions performed more than the expected 45 procedures per 250 000 population per year and 22% were restricted in their use by hospital or primary care trusts.7 Limited access to resources (facilities, trained personnel or both) and inadequate reimbursement are potential reasons for failure of capsule services to expand. Currently (2014–2015), the Healthcare Research Group (HRG) code of FZ42Z for wireless CE attracts a tariff of £909, but Monitor and National Health Service England propose reducing this to £640 (FZ42A, 19 years and over) or £887 (FZ42B, 18 years and under) for 2015–2016.8 Capsule endoscopes cost between £360 and £422 plus VAT, but the CE procedure additionally involves bowel preparation, a day case admission, nursing time to perform the procedure and download the data, clinician time to read and report the video and the cost of renewables, printing, data storage and so on. Failure to make the procedure at least cost neutral is likely to hamper service development.

The experience of the majority of units offering CE is that demand increases with time, particularly if use is not restricted, and anticipating this may help to plan ahead.7 Waiting times may increase if performing CE depends on a single individual or limited trained personnel. But the commonest bottleneck arises because of inadequate time or personnel to read and report CE videos.

DAE has been slower to develop because of the complexity of the procedure and competing pressures at a time when demand for conventional upper and lower GI endoscopy continues to increase. In 2012, eight units were regularly (most weeks) performing DAE.7 Information provided by the UK Small Bowel Endoscopy Users’ Group suggests that this has now increased to 11 centres, with 5 performing >50 procedures in the year 2014. Interestingly, there are a similar number of units in possession of the equipment but performing few if any procedures. The reasons for this are unknown but presumably relate to time or cost pressures, or inadequate training and support. There remains no specific HRG code for DAE, reimbursement for which has either been agreed locally or by assigning a ‘best fit’ code.

All units offering CE need to anticipate the need for DAE to obtain material for histological analysis or for therapeutic intervention. Previously, our experience was that one DAE was needed per 25 CE procedures (figure 1), but with increasing DAE experience, better organisation of DAE lists and appropriate funding, this has increased to a ratio of 1 in 12. Therefore, a unit performing 90 CE procedures (a very conservative estimate for 0.5 m population) might anticipate referring about seven or eight patients per annum to a centre offering DAE.

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Figure 1

Graph of small bowel capsule endoscopy (CE) and device-assisted enteroscopy (DAE) procedures performed per year at Sheffield Teaching Hospitals National Health Service Foundation Trust.

Organisation of services

Our service at Sheffield Teaching Hospitals NHS Foundation Trust has expanded rapidly since 2002, undergoing frequent adaptations to cater for increasing demand and performing >800 small bowel capsule procedures in 2013–2014. The following comments are made on the basis of this experience and a straw poll of the UK Small Bowel Endoscopy Users’ Group members. Central to the service must be a facility (an endoscopy or investigation unit) to house the equipment and care for the patients and where several staff (to allow for cross cover) can be trained to operate the computer software, use the data recorders, perform CE and use a ‘real-time viewer’. A quiet area should be provided for reading and reporting CE videos without distraction.

More experienced units value the role of a nurse practitioner to oversee the service, most of whom are also involved in prereading CE videos and saving any still images (thumbnails) thought to be relevant in order to allow the clinician to interpret any potentially abnormal findings and produce the written report. Niv and Niv9 have shown that an experienced nurse ‘prereader’ was a safe, reliable and cost-effective method to reduce CE reporting time. Although not yet a widely adopted practice, Drew et al10 demonstrated that with appropriate experience and training an advanced endoscopy nurse can report CE procedures and provide appropriate management advice to an equivalent standard as a consultant gastroenterologist.

As patients may be referred having had varying degrees of investigation and information from many different clinicians, nurse-led telephone or preassessment clinics are regarded as helpful. Patient information leaflets and protocols for referring for CE, including when to consider prior investigation of luminal patency (using radiological methods, PillCam patency device (Given Imaging, Yoqneam, Israel), or both) and performing CE, are widely used. Networking of computer systems provides a more secure portal for data storage than detachable devices and for access by referring clinicians from neighbouring hospitals. Finally, a consultant with a specific interest in CE and dedicated time is necessary to run a service. Suggestions for starting and developing a small bowel investigation facility are presented in box 1.

Practical considerations

Cautions and contraindications

Cautions and contraindications to CE are listed in box 2. Capsule retention is reported in approximately 2% of procedures overall. The risk is primarily related to indication for the procedure. It has not been documented in normal small bowel, occurs in approximately 1% of patients with obscure GI bleeding, rising to 13% in patients with known Crohn's disease.14 Other risk factors include prolonged use of non-steroidal anti-inflammatory drugs and previous abdominopelvic irradiation.14 ,15 The World Organisation of Digestive Endoscopy–European Crohn's and Colitis Organisation consensus guidelines recommend considering CT or MR enterography as first-line modalities to evaluate the small bowel in patients with established Crohn's disease because they additionally demonstrate transmural and extramural complications.16 However, confirming functional patency using a PillCam patency device is also recommended in the event that CE is required because of unremarkable or non-diagnostic cross-sectional imaging. Small bowel radiology cannot be guaranteed to exclude short strictures,17 and our practice is to consider a preprocedure patency capsule in any high-risk patient. This is a dissolving capsule (the same size and shape as the capsule endoscope) containing a radiofrequency tag. Failure to detect the radio frequency signal using a handheld scanner 30 h after ingestion suggests functional patency of the GI tract and predicts uncomplicated excretion of the capsule.18 ,19

Box 2

Cautions and contraindications to small bowel capsule endoscopy

• Crohn's disease

• Prolonged non-steroidal anti-inflammatory drug use

• Severe abdominal pain or obstructive sounding symptoms

• Previous abdominopelvic radiotherapy

• Altered upper gastrointestinal anatomy

• Dysphagia

A standardised CE referral form requiring information regarding the indications for the procedure and absence of contraindications allows a screening opportunity for patients at high risk of capsule retention and appropriate selection of those who would additionally benefit from luminal patency assessment.

About half of patients who swallow a patency device fail to excrete it within 30 h, in which case it needs to be located either to the small bowel (raising the possibility of a stricture) or the colon (in which case luminal patency is confirmed). This cannot be done with confidence on a plain abdominal film and conventionally has been achieved using either fluoroscopy or whole abdominal CT scan, both of which require considerable organisation, out-of-hours procedures and substantial irradiation. Our protocol includes the use of a scout film, used to target a limited abdominal CT scan (which involves minimal radiation exposure) to localise the exact position of the patency device and determines luminal patency with a sensitivity of 99.4%.20 Of 400 high-risk patients undergoing the patency protocol, only one (0.6%) retained a capsule after a limited CT scan was incorrectly reported as showing the PillCam patency in the colon. Retrospective review of this case showed the device in the terminal ileum, mistaken as the caecum because it was obstructed, dilated, contained faeces (subsequently recognised as the ‘small bowel faeces sign’ of obstruction) and the patient happened to have a high-lying caecum that lay outside the field of the limited slice CT scan. Collaboration with the local radiology service, a precompleted request form and predesignated CT slots allow this aspect to be entirely nurse led.

A representation of the flow pathway used within our own department is demonstrated in figure 2.

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Figure 2

Flow chart representing the patient pathway through the capsule endoscopy service at Sheffield Teaching Hospitals NHS Foundation Trust. ABDO, abdominal; CE, capsule endoscopy; CT, computed tomography.

A potential risk of interference with permanent implantable cardiac devices such as pacemakers and defibrillators by the radiofrequency of the capsule and data recorder has been anticipated, although several studies of many different device models have failed to demonstrate this and therefore they should not be considered as contraindications.21–23 However, not every model of every device has been tested and therefore it is prudent to risk-assess each patient individually. The development of a local policy in agreement with the resident cardiology department is a sensible approach to avoid confusion.

Bronchial aspiration is a rare complication, with only a small number of cases reported in the literature.24–27 This occurs more commonly in older patients with no prior history of swallowing disorders and may be asymptomatic. Use of a ‘real-time’ viewing device to determine the position of the capsule can be reassuring if doubt exists following ingestion. Expectoration can be achieved spontaneously by coughing, or retrieval may be necessary using a bronchoscope.24 ,28

Quality assurance

Awareness of quality within endoscopy services has peaked over the last 10 years, prompted by patient safety initiatives and the introduction of national endoscopic screening programmes. Quality within colonoscopy practice is known to be variable and thus has been subject to major efforts to standardise practice and service delivery.53 ,54 In the UK, this has been accomplished by a central regulatory body, the Joint Advisory Group (JAG), using quality assessment tools such as the Global Rating Scale to standardise service delivery and a formal certification process for independent endoscopy practice.55 The latter is achieved through an internet-based portfolio, the ‘JAG Endoscopy Training System’, which enables acquisition of skills to be documented and measured against preset criteria.56 The identification of specific quality parameters is central to this process and should encompass the multiple steps, both clinical and non-clinical, that make up the service delivered.

Quality improvement is considered a fundamental aspect of high-quality, cost-effective healthcare. Using the principles of quality improvement may allow more efficient, patient-centred small bowel services to be developed, while facilitating audit and assessment of service provision. Since CE relies on skills of observation primarily, rather than the practical skills necessary to perform conventional endoscopy, it would require a distinct approach. Simple, reproducible outcomes that can be easily measured and audited are preferable for widespread implementation. A number of potential considerations are presented in box 3.

Training

With the development and growth of a new CE service comes the inherent need to develop diagnostic skill, knowledge and certification of clinicians.57 Unlike the technical proficiency requirements of conventional endoscopy, the CE skill set predominantly comprised observation and interpretation of findings acquired from computer images. A competent capsule endoscopist should be able to effectively optimise visualisation of the small bowel, accurately identify and diagnose pathology and apply appropriate management.58

In the UK, CE training is not a mandatory requirement of specialist gastroenterology training and many trainees have never received any formal training.57 A small number of structured, 1-day courses providing ‘hands-on’ computer-based training for beginners have been available for several years. Delegates are trained how to perform the procedure, navigate the software and apply basic interpretation to CE findings. A higher-level training course is also available for established users wishing to advance their interpretations skills. Attending a practical CE course has been shown to significantly improve lesion recognition and classification skills.59 Web-based learning methods with demonstrable knowledge gains have also been documented; however, these have not been publicly available.60 The value of hands-on training courses has been reflected in published training recommendations by the American Society for Gastrointestinal Endoscopy, which include completion of a hands-on course, in addition to supervised video reporting following completion of a GI fellowship.58

There are currently no universally agreed competency frameworks for the assessment of competence in CE. Development and progression of reading skill can be assessed by supervised and double reading, correlation of findings and provision of feedback to the trainee. A recent study advocates that trainees should read a minimum of 20 CE studies before undergoing any assessment of competence, regardless of endoscopy experience.61 To formally test knowledge and skill, some units have developed in-house assessment tools comprising multiple-choice questions, case-based video clips and report completion.61 In the UK, a pathway for CE training and certification for specialist trainees is currently being developed in association with JAG and the Royal College of Physicians with expected completion in 2015. A potential model pathway for training is illustrated in figure 3. A core curriculum would enable all trainees to assess patients for consideration of CE imaging. Advanced training would provide a syllabus and skills learning programme to ensure the acquisition of sufficient knowledge and skill to enable a gastroenterologist to provide a CE service in a specialist capacity.

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Figure 3

Flow chart representing a potential training pathway for competence in capsule endoscopy. *Applies to medical capsule endoscopy trainees. CE, capsule endoscopy; JAG, Joint Advisory Group.