Reviews on Second Generation Fitã‚â® Colon Cancer Test
Endosc Int Open. 2021 Apr; ix(4): E562–E571.
2nd-generation colon capsule endoscopy for detection of colorectal polyps: Systematic review and meta-analysis of clinical trials
Tobias Möllers
aneDivision of Clinical Epidemiology and Aging Inquiry, German Cancer Inquiry Centre, Heidelberg, Deutschland
Matthias Schwab
twoDr. Margarete Fischer Bosch Constitute of Clinical Pharmacology, Clinical Pharmacogenomics and Cancer, Stuttgart, Germany
3Section of Clinical Pharmacology, University Hospitals Tubingen, Tubingen, Germany
4Department of Chemist's shop and Biochemistry, University of Tübingen, Tübingen, Federal republic of germany
5German Cancer Consortium, Partner Site Tubingen, Tubingen, Germany
Lisa Gildein
viSection of Gastroenterology and Hepatology, Robert Bosch Hospital, Stuttgart, Germany
Michael Hoffmeister
oneDivision of Clinical Epidemiology and Aging Research, German Cancer Research Eye, Heidelberg, Deutschland
Jörg Albert
sixSection of Gastroenterology and Hepatology, Robert Bosch Hospital, Stuttgart, Deutschland
Hermann Brenner
1Partition of Clinical Epidemiology and Aging Research, German Cancer Research Centre, Heidelberg, Germany
sevenDivision of Preventive Oncology, National Heart for Tumor Diseases, Heidelberg, Germany
eightGerman Cancer Consortium, Heidelberg, Germany
Simon Jäger
2Dr. Margarete Fischer Bosch Constitute of Clinical Pharmacology, Clinical Pharmacogenomics and Cancer, Stuttgart, Germany
3Department of Clinical Pharmacology, University Hospitals Tubingen, Tubingen, Federal republic of germany
Received 2020 Jul vii; Accepted 2020 October 19.
Abstruse
Background and report aims Adherence to colorectal cancer (CRC) screening is still unsatisfactory in many countries, thereby limiting prevention of CRC. Colon capsule endoscopy (CCE), a minimally invasive procedure, could be an alternative to fecal immunochemical tests or optical colonoscopy for CRC screening, and might increase adherence in CRC screening. This systematic review and meta-analysis evaluates the diagnostic accurateness of CCE compared to optical colonoscopy (OC) as the golden standard, adequacy of bowel preparation regimes and the patient perspective on diagnostic measures.
Methods We conducted a systematic literature search in PubMed, EMBASE and the Cochrane Register for Clinical Trials. Pooled estimates for sensitivity, specificity and the diagnostic odds ratio with their respective 95 % confidence intervals (CI) were calculated for studies providing sufficient data.
Results Of 840 initially identified studies, 13 were included in the systematic review and upwards to 9 in the meta-assay. The pooled sensitivities and specificities for polyps ≥ 6 mm were 87 % (95 % CI: 83 %–90 %) and 87 % (95 % CI: 76 %–93 %) in 8 studies, respectively. For polyps ≥ x mm, the pooled estimates for sensitivities and specificities were 87 % (95 % CI: 83 %–90 %) and 95 % (95 % CI: 92 %–97 %) in 9 studies, respectively. A patients' perspective was assessed in 31 % (north = 4) of studies, and no preference of CCE over OC was reported. Bowel preparation was acceptable in 61 % to 92 % of CCE exams.
Conclusions CCE provides high diagnostic accurateness in an fairly cleaned big bowel. Conclusive findings on patient perspectives require further studies to increase acceptance/adherence of CCE for CRC screening.
Introduction
Colorectal cancer (CRC) is one of the most common cancers worldwide as well as one of the leading causes of death from cancer amongst women and men 1 . Reverse to other cancers, CRC usually develops slowly from not-advanced adenomas to advanced adenomas and CRC over many years 2 . This offers a cracking opportunity for prevention in form of screening measures such as optical colonoscopy (OC) or fecal immunochemical tests (FIT). Despite the multifariousness of secondary prevention measures existence available three , the number of individuals accepting screening offers for CRC remains low. During the initial 10 years of the German screening colonoscopy plan, just about 25 % of eligible individuals (55–79 years old) actually underwent OC for screening purposes 4 . Substantial efforts accept been fabricated to increase screening participation. This includes pre-declaration messages, personal invitation that includes the FIT, and reminder messages for FIT testing or personal invitations for OC, all of which take led to a higher screening adherence v six 7 . Further increase in screening adherence could potentially reduce the incidence of and bloodshed from CRC eight . Nevertheless, barriers such equally a lack of awareness of the risks of CRC and negative attitudes towards the screening procedures decrease the participation in CRC screening programs 9 .
Therefore, other ways to increase participation in CRC screening have to be considered, which include alternative procedures beyond OC or FIT. Colon sheathing endoscopy (CCE) has been bachelor since 2006 and is already recommended in case of incomplete OC or patient refusal to undergo the OC procedure x eleven . In addition, CCE has shown considerable advances in its accurateness to detect polyps with the introduction of the second-generation capsules. This has been confirmed in a meta-assay of CCE studies published in 2016, where polyps ≥ 10 mm were detected with a pooled sensitivity and specificity of 87.3 % and 95.iii %, taking OC as the reference standard 12 . CCE might increase participation in CRC screening 13 , and serve every bit a possible filter examination to decide which individual should undergo OC 14 . Yet, CCE is non an established part of CRC screening programs to engagement.
To support the discussion of CCE every bit a CRC screening method, we conducted an updated systematic review and meta-analysis on the diagnostic accurateness of the second generation CCE (CCE-2) compared to the gilded standard OC. As a secondary aim, we assessed the patient perspective on diagnostic measures reported in the included clinical trials which will be an of import attribute for the acceptance of CCE in the screening setting.
Materials and methods
Data sources and search strategy
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. A protocol was submitted to PROSPERO but no identification number has been assigned by the fourth dimension of submission of the manuscript. PubMed, EMBASE and the Cochrane Key Register of Controlled Trials were searched from inception to Jan 22, 2020. Medical subject headings, non-medical subject headings terms and synonyms for the following terms were used to identify possible studies for inclusion: Colon AND Polyps AND Colon capsule endoscopy. The full list of search terms is given in Tabular array 1 . The reference lists of studies eligible for full-text screening were searched for additional relevant studies.
Table one
Characteristics of included studies.
| Author, twelvemonth | State(ies) | Sample size enrolled/included | Age in years | Female person % | Indications, n (%) | |||||
| CRC Screening | FOBT/FIT + | FDR | Personal/family history | Symptoms | Other | |||||
| Rex, 2015 19 | Us, Israel | 884/689 | MN: 57 | 56 | 689 (100) | – | – | – | – | – |
| Voska, 2019 22 | Czech Republic | 236/225 | MN: 59 | 47 | 225 (100) | – | – | – | – | – |
| Holleran, 2014 xiv | Ireland | NA/62 | MN: 63 | 45 | – | 62 (100) | – | – | – | – |
| Rondonotti, 2014 24 | Italy | 54/50 | MN: 59 | 42 | – | 50 (100) | – | – | – | – |
| Kobaek-Larsen, 2017 21 | Kingdom of denmark | 380/253 | MD: 64 | 42 | – | 253 (100) | – | – | – | – |
| Pecere, 2019 23 | Italia, Spain | 222/178 | MN: 61 | 44 | – | 178 (100) | – | – | – | – |
| Adrian-de-Ganzo, 2015 25 | Spain | 325/233 | Dr.: 55 | 52 | – | – | 233 (100) | – | – | – |
| Parodi, 2018 26 | Italy, Spain | 230/177 | Medico: 57 | 55 | – | – | 177 (100) | – | – | – |
| Kroijer, 2019 27 | Denmark | NA/180 | MN: 59 | 48 | – | – | – | 180 (100) | – | – |
| Eliakim, 2009 xx | Israel | 103/98 | MN: 50 | 34 | 31 (32) | 21 (21) | – | 33 (34) | xx (20) | – |
| Spada, 2011 28 i | Italy, Spain, Germany, Belgium, Netherlands, French republic, Sweden | 117/109 | MN: sixty | 39 | 25 (21) | 7 (vi) | – | 52 (44) | 68 (58) | – |
| Hagel, 2014 xviii | Federal republic of germany | NA/24 | MN: 51 | 42 | 13 (55) | – | – | 7 (29) | – | four (16) |
| Morgan, 2016 29 i | USA | 51/50 | MN: 60 | 55 | 28 (56) | 1 (2) | – | 11 (22) | 29 (58) | – |
| Total 1 | 2,868/ii,328 | – | – | 1011 (43.4) | 572 (24.6) | 410 (17.6) | 283 (12.1) | 117 (5.0) | 4 (0.2) | |
Study selection
Eligibility criteria included full-texts of clinical trials published in English language or German language language, the utilise of CCE-2, OC as the reference standard, a clear comparison of CCE-2 and OC, participants from an average risk screening population (i. due east. persons at an average gamble of developing CRC), patients with family history of CRC, patients referred later on positive FIT/fecal occult blood exam (FOBT) or imaging tests or a written report population with a range of indications. Exclusion criteria included: CCE-2 studies with other endpoints than polyps, neoplasia, adenomas or CRC, a suboptimal reference standard (e. g. computed tomographic colonography [CTC]), and other study designs than clinical trials (database analysis). Based on our eligibility criteria, 2 reviewers (TM and SJ) performed the study selection independently. In case of discrepancy, word and further review followed.
Data extraction
Data extraction was washed independently past two reviewers (TM and SJ or LG) and included the following data: author, year of publication, country(ies), number of centers, study design, bowel preparation protocol, availability of either or both per-patient and per-polyp analysis, timing of OC and CCE-two, unblinding of CCE-2 results at OC, number of patients enrolled/included, reasons for exclusion, historic period (mean or median), sex distribution, indications for CCE-2/OC, patient perspective questions/questionnaire and upshot of patient perspective, charge per unit of acceptable cleansing at CCE-2, CCE-ii excretion rates at dissimilar timings (< 8 hours, 8–10 hours, > ten hours), colon transit fourth dimension, values of diagnostic accuracy, number of patients with any polyp size or ≥ 6 mm/ ≥ 10 mm polyps at CCE-2 and OC, number of patients with at to the lowest degree 1 adenoma of any size or ≥ 6 mm/≥ 10 mm at CCE-2 and OC, number of patients with at least one invasive CRC at CCE-2 and OC, rate of adverse events at CCE-2 and OC.
Run a risk of bias assessment
The Quality assessment of Diagnostic Accurateness in Systematic Reviews – 2 (QUADAS-two) tool was used to assess methodological quality and potential bias amongst included studies by two independent reviewers (TM, LG) 15 .
Descriptive synthesis
All included full texts were part of the descriptive synthesis for the following aspects: characteristics of included studies, patient perspectives, bowel grooming and charge per unit of acceptable cleansing, written report related adverse events as well every bit diagnostic accuracy of polyps and adenomas.
Statistical analysis
Per-patient sensitivity, specificity and the diagnostic odds ratio (DOR) with the respective 95 % confidence interval (CI) were calculated among individual studies providing sufficient information for polyps ≥ 6 mm and polyps ≥ 10 mm. Heterogeneity was calculated past chi-squared based Q tests and the inconsistency index I 2 . Random-effects models were calculated when significant heterogeneity (Q test of p < .05 or I 2 > 50 %) was present, otherwise fixed-furnishings models were used. Subgroup analyses were conducted based on the indication when possible. Deek's funnel plots were created and Begg's and Egger's tests were done to assess potential publication bias. The analyses were done using the "meta" and "mada" packages in R version three.16.3 16 17 . All statistical tests were two-sided and P < .05 was considered statistically significant.
Results
Search results
The search identified 840 articles, of which 213 duplicates were removed ( Fig. i ). After careful title and abstruse screening, 38 articles remained for total text review. I additional publication was identified by screening of the reference list of those studies. Of the 39 articles selected for full-text review, 26 were excluded for the following reasons: 12 studies used the outset generation of CCE, for vii articles no total-text was bachelor (eastward. k. conference abstracts), three studies were not clinical trials (east. thousand. database analysis), ii studies enrolled participants with an indication excluded by our review's study protocol, one study had no clear comparison of CCE-two and OC, and 1 study assessed a different endpoint. A total of 13 studies met the criteria to be included in the systematic review, of which nine were eligible for meta-analyses.
Flow diagram of the systematic literature search.
Written report characteristics
Study characteristics of included studies are displayed in Table 1 . Overall, two,328 participants were included in the studies (24 eighteen to 689 nineteen ). Hateful or median age of participants ranged from 50 years 20 to 64 years 21 and 34 % 20 to 56 % 19 of participants were female person. Studies were conducted amongst an average run a risk screening population (north = 2) 19 22 , FIT/FOBT + test individuals (n = four) 14 21 23 24 , first degree relatives (FDR) of CRC patients (due north = 2) 25 26 , patients with personal or family history (n = 1) 27 , and mixed populations (north = iv) eighteen twenty 28 29 . In total, 1011 (43.4 %), 572 (24.vi %), 410 (17.half dozen %), 283 (12.i %), 117 (5.0 %), 4 (0.ii %) participants were included because of average risk CRC screening, FIT/FOBT + tests, FDR of CRC patients, personal/family unit history, gastrointestinal symptoms or other reasons, respectively.
Risk of bias and publication bias
The risk of bias for each study is shown in Table A2 . A low, unclear or high take a chance of bias was present in 5, 6, and one written report, respectively. The index test was rated with a depression risk of bias for all studies. Merely 1 report had a high risk of bias for the reference standard and ii for the menstruum and timing of patients.
The funnel plots for publication bias can be seen in Fig. A1 . In that location was no bear witness for publication bias from the logarithms of DOR for studies with polyps ≥ 6 mm (n = 8; Egger's exam: P = .4741, Begg'due south test: P = .6523) or ≥ 10 mm (n = 9, Egger's test: P = .7075, Begg's test: P = i.000).
Patient perspectives
The results of the patient perspective are shown in Table 2 . Overall, four studies (31 %) reported an cess of the patient perspective. The participants in one study preferred OC (n = 120, 53 %) over CCE-ii (due north = 105, 47 %) 22 , while 41 % (n = 72) preferred CCE-2 over OC (north = twoscore, 23 % preferred OC; n = 65, 37 % had no preference) in another study. 26 In a trial comparison CCE-2, CTC and OC, 78 % (n = 39) preferred CCE-2 over CTC (due north = 11, 22 %), however "preference for OC" was non given as an option for that question. 24 In the written report past Adrian-de-Ganzo et al., which allowed patients to switch groups after randomization to either CCE-two or OC, 33 % (northward = 39) chose to undergo OC instead of CCE-2, while only fifteen % (n = 17) decided to undergo CCE-2 instead of OC 25 .
Table 2
Studies because patient perspectives and respective results.
| Author, year | Domain(due south) of patient perspective | Questions/questionnaire used | Results of patient perspective | ||
| Preference | Satisfaction | Other | |||
| Voska, 2019 22 | Acceptability, preference of methods | Questionnaire (not specified) | 105 (47 %) CCE, 120 (53 %) OC | – | – |
| Rondonotti, 2014 24 | Preference of methods, reason for selection | Two questions | 39 (78 %) CCE, xi (22 %) CTC | – | Reasons: bloating/balmy pain during CTC |
| Adrian-de-Ganzo, 2015 25 | Satisfaction | Endoscopic Satisfaction Questionnaire | – | 9 (82 %) satisfied i | CCE less unpleasant i |
| Choice of CCE/OC | Questionnaire to determine reason for irresolute assigned screening strategy | CCE to OC: 39 (33 %) OC to CCE: 17 (15 %) | OC: 35 (xc %) avoid 2nd bowel grooming, iii (8 %) more confident about OC, one (3 %) unpleasant experience of FDR CCE: xix (100 %) fear of OC | ||
| Parodi, 2018 26 | Satisfaction, preference of methods | Questionnaire, 10-indicate scales (discomfort bowel preparation, swallowing of capsule, during procedure, nausea/pain OC, satisfaction rate CCE/OC, preference CCE) | 72 (41 %) CCE, twoscore (23 %) OC, 65 (37 %) no preference | Rate: 9.1 CCE, 9.4 OC | – |
Regarding satisfaction, 9 of 11 participants (82 %) receiving CCE-two and OC were satisfied with the procedures in one study 25 . Some other study reported similar rates of satisfaction for CCE-2 (9.i) and OC (9.4) on a 10-bespeak scale amidst patients receiving both measures 26 .
Bowel preparation and adequate cleansing
The findings on bowel training and the rate of adequate cleansing are displayed in Table iii . The majority (62 %) used some kind of laxative and two doses of polyethylene glycol (PEG) with two to 4 L of volume in full. In terms of boosters, seven studies (54 %) used sodium phosphate, 3 studies (23 %) PEG alone or in combination with other products (e. g. bisacodyl) and 1 study each used sodium sulfate or magnesium citrate. Ten studies (77 %) included further optional boosters in their bowel preparation protocols in example the CCE-2 did not reach pre-defined sections of the gastrointestinal tract in time. The rate of adequate cleansing for CCE-2 exam ranged from 61 % 29 to 92 % 14 27 . There was no clear indication as to which bowel preparations yielded the highest charge per unit of adequate cleansing for CCE-2 examination.
Table three
Bowel training and rate of adequate cleansing.
| Author, year | Bowel preparation | Adequate cleansing (%) | ||||
| Laxative (type; number; dose) | PEG (doses, full) | Booster | ||||
| Type | Volume (Total) | Optional | CCE | |||
| Rex, 2015 19 | Senna; 4; 12 mg | ii, iv Fifty | NaS | 6 oz | x mg metoclopramide, 3 oz suprep, 10 mg bisacodyl | 80 |
| Voska, 2019 22 | – | ii, 4 L | NaP | 30 mL | 25 mL NaP, 2 g glycerin suppository | xc |
| Holleran, 2014 14 | Senna; 4; NA | two, four L | NaP, | 75 mL | x mg bisacodyl | 92 |
| Rondonotti, 2014 24 | Bisacodyl; 4; 5 mg | 2, 200 chiliad | NaP | 45 mL | – | seventy |
| Kobaek-Larsen, 2017 21 | Magnesium oxide; 2; m mg | 2, two L | PEG Bisacodyl | 1 L 10 mg | – | 85 |
| Pecere, 2019 23 | Senna; 4 | 2, 4 L | NaP | threescore mL | 10 mg bisacodyl | 88 |
| Adrian-de-Ganzo, 2015 25 | Senna; NA; 24 mg | ii, 2.3 L | PEG | fifty mg | 50 mg PEG, 15 mg mosapride, 10 mg bisacodyl | eighty |
| Parodi, 2018 26 | – | 2, iv L | NaP | 40 mL | x mg metoclopramide, twenty mL NaP, 10 mg bisacodyl | 68 |
| Kroijer, 2019 27 | – | two, 2 50 | PEG Sulfate-based PEG + gastrografin | 1 Fifty 1 L 1 L + 75 mL | ten mg bisacodyl | 92 |
| Eliakim, 2009 twenty | – | 2, 2 L | NaP | 30 mL | 15 mL NaP, ten mg bisacodyl | 78 |
| Spada, 2011 28 | Senna; iv; 12 mg | 2, ii Fifty | NaP | 55 mL | ten mg bisacodyl | 81 |
| Hagel, 2014 xviii | Senna; 4; NA | 2, 2 L | NaP | thirty mL | 15 mL NaP, ten mg bisacodyl | 90 |
| Morgan, 2016 29 | – | ii, 4 L | Magnesium citrate | 8 oz | 10 mg metoclopramide 5 oz magnesium citrate 10 mg bisacodyl | 61 |
CCE, colon sheathing endoscopy; NA, non available; NaP, sodium phosphate; NaS, sodium sulfate; PEG, polyethylene glycol.
Agin events
The reported adverse events (AEs) for each study are shown in Table A3 . In total, 240 mild AEs were reported in 2,328 participants (10.3 %). The proportion of mild AEs in study participants ranged from 1.7 % 25 to 25.3 % 23 , of which 83 % (33 % 22 to 100 % 18 twenty 23 27 ) were related to the bowel grooming, 10 % (viii % xix to 75 % 25 ) to the OC procedure itself, and 6 % (2 % 19 to 60 % 26 ) to the CCE procedure. A total of viii moderate or astringent AEs due to the OC process were reported.
Diagnostic accuracy of whatever polyps and adenomas
The sensitivities and specificities extracted for individual studies are reported in Table A4 . For any polyps, sensitivity and specificity ranged from 82 % 22 to 95 % 14 and 65 % 14 to 86 % for CCE-2 compared to OC eighteen 22 . The sensitivity and specificity of CCE-2 for adenomas ≥ six mm ranged from 81 % 23 to 95 % 26 and lxxx % 26 to 82 % compared to OC 29 . Adenomas ≥ 10 mm were detected with a sensitivity and specificity of 85 % 23 to 100 % 22 , and 92 % 26 to 98 % compared to OC 22 . Adrian-de-Ganzo et al. did non report sensitivities or specificities only found no meaning difference in the detection rate of non-advanced and avant-garde adenomas too as significant lesions for CCE-2 and OC 25 .
Diagnostic accuracy for polyps ≥ 6 mm and ≥ 10 mm
The results of the meta-analyses for polyps ≥ 6 mm and ≥ x mm are shown in Fig. 2 , Fig. iii , and Fig. A2 . For polyps ≥ 6 mm (n = 8 studies), the pooled sensitivity, specificity, and DOR of CCE-ii were 87 % (95 % CI: 83 %–90 %), 87 % (95 % CI: 76 %–93 %), and 49.6 (95 %CI: 22.1–111.4) with OC as the reference standard, respectively. There was significant heterogeneity nowadays for specificity (I 2 91 %, P < .01) and the DOR (I two 71 %, P < .01). Among the average risk screening population (n = two studies), the sensitivity and specificity of CCE-2 were 86 % (95 % CI: 80 %–90 %) and 95 % (95 % CI: 91 %–97 %) compared to OC. Amidst FIT/FOBT + , FDR, and study populations with mixed indication (n = 5 studies) the sensitivity and specificity for CCE-two were 88 % (95 % CI: 82 %–93 %) and 80 % (95 % CI: 69 %–87 %) compared to OC.
Woods plots showing the pooled sensitivity and specificity of CCE-2 for polyps ≥ 6 mm.
Woods plots showing the pooled sensitivity and specificity of CCE-2 for polyps ≥ 10 mm.
For polyps ≥ x mm (n = 9 studies), the pooled sensitivity, specificity, and DOR of CCE-ii were 87 % (95 % CI: 83 %–90 %), 95 % (95 % CI: 92 %–97 %), and 140.3 (95 % CI: 89.ii–220.6) with OC as the reference standard, respectively. Significant heterogeneity was present for the specificity (I 2 59 %, P = .01) hither as well. When stratifying the pooled estimates according to indication, the sensitivities and specificities of CCE-ii compared to OC were 85 % (95 % CI: 77 %–91 %) and 98 % (95 % CI: 94 %–99 %) for the average adventure screening population (north = 2 studies) and 87 % (95 % CI: 82 %–91 %) and 93 % (95 % CI: 88 %–96 %) for studies amidst FIT/FOBT + participants (north = three studies). For FDR or mixed populations (n = iv studies), the sensitivity and specificity of CCE-two were 89 % (95 % CI: 79 %–94 %) and 93 % (95 % CI: 89 %–95 %) compared to OC.
Discussion
This systematic review and meta-assay focused on the diagnostic accuracy, patient perspective, bowel training and charge per unit of adequate cleansing in clinical trials comparing CCE-2 and OC. Our review is an update of a previously performed analysis 12 , including recently published data, and with additional focus on patient perspective regarding CCE. Nosotros found that CCE-2 has a high diagnostic accuracy for polyps ≥ half-dozen mm and ≥ 10 mm. About adverse events were balmy and usually related to bowel preparation rather than the CCE exam itself and the rate of adequate bowel cleansing varied widely among studies. Furthermore, at that place is mixed evidence on whether or non CCE-2 might exist accepted by average risk screening individuals.
The results of our systematic review and meta-analysis are important when considering CCE-2 as a regular CRC screening test. First, the overall diagnostic accuracy of CCE-2 for polyps and adenomas was adequate and supports the implementation of CCE-2 as a valuable screening option. This is in line with the previously published meta-analysis by Spada et al. 12 , but is corroborated by additional clinical trials (n = 4). When considering the accuracy of CCE-2 compared to OC for any polyps (regardless of size), the sensitivity was similar to those for polyps ≥ 6 mm and highest amidst FIT + participants (95 %) 14 . Nonetheless, the specificities for polyps of any size were considerably lower than the specificities for larger polyps ( ≥ vi mm). But in a few studies, histopathologic diagnoses were reported. Here, adenomas ≥ half dozen mm and ≥ 10 mm showed similar sensitivities as "polyps" of the same size (up to 95 % amongst FDR of CRC patients 26 ). Specificities were just comparable for adenomas and "polyps" ≥ 10 mm. Regarding the meta-analyses of polyps ≥ 6 mm and ≥ x mm, the high overall diagnostic accuracy is a adept argument to include CCE-2 in routine CRC screening. However, just two studies were conducted in cohorts of individuals with average CRC risk 19 22 , which underlines the need for further studies in the screening population. The results from the pooled analysis of FIT/FOBT + participants indicate that CCE-2 might indeed be a valuable method to offer as an culling to OC for FIT/FOBT positive individuals xiv 21 24 . It is important to note that due to the miss-rate of polyps in OC xxx and OC being the reference standard, the number of false-positive results of CCE might be overestimated. Hence, the diagnostic accuracy of CCE-2 might be even higher than reported and advances in technology including a third generation of CCE might enhance the diagnostic accurateness even more. In sum, CCE-2 is a valuable option for CRC screening. Other than a standard screening selection, it could also exist offered to patients at a higher chance for CRC (FIT/FOBT + or FDR) equally a selector for referral to colonoscopy with polyp removal.
Only iv of 13 clinical trials comparing CCE-two to OC (31 %) reported the patient perspective. Patients' acceptance of screening methods is crucial as perception of risk and benefit determines the success of a screening measure. The available studies do not indicate preference for OC 22 vs. CCE-2 26 . Additionally, in a trial among FDR of CRC patients, where participants could still choose between OC or CCE subsequently being randomly assigned to 1 group, more participants chose OC over CCE-2 than vice versa. Interestingly, the screening adherence was similar in both groups (CCE-2: 57 %, OC: 56 %) 25 . Even so, awareness of CRC is probably higher amid FDR, and the higher probability of polyp detection might accept led to the decision for OC, which allows detection and removal within one unmarried procedure. According to 1 written report, the lay public prefers non-invasive procedures (CTC or CCE) to OC for general diagnostic purposes but not after a positive FIT/FOBT exam 31 . In another report on FIT + individuals, CCE-2 was preferred over CTC 24 . To our knowledge, there was a unmarried study investigating boilerplate risk screening population, coming with a four-fold increase of screening uptake, when offering CCE as an culling to OC xiii . Thus, offer CCE as an alternative outpatient procedure might result in increasing screening adherence 32 . Currently, the price for a CCE-2 process is priced at most 1,000 EUR 33 , which might decrease when implemented as a screening option including automated imaging assay. Nevertheless, to be considered cost-effective, an increase of screening uptake of xx % or more than for CCE-ii over OC is required 33 . Also, at defecation, the sheathing generally gets disposed in the toilet, which is not a sustainable solution for a high-tech product. A improve concept will exist needed for capsule recovery when the capsule is offered to a large number of people. In summary, future inquiry should focus on the perspective of the screening individual, including the question whether offering CCE would increases participation among average risk individuals.
Overall, the various bowel preparation protocols resulted in a wide range of bowel cleanliness at CCE-2 exam (61 %–92 % "adequate cleansing"). There did not seem to be a clear indication as to which bowel preparation regimen yields the highest cleansing rate. For example, among the four studies with a cleansing rate of ≥ ninety %, two used laxatives xiv 18 and two did non 22 27 . Furthermore, they included different volumes of PEG and types and volumes of boosters and optional boosters. Notwithstanding these uncertainties, the rate of acceptable cleansing remains a primal effect for the success of CCE examinations, as this influences the diagnostic accurateness 34 . On the other hand, by pushing for more all-encompassing or complicated bowel preparations to reach acceptable levels of cleansing, the possibility of discouraging patients and dr. alike from considering CCE at all is quite real. It is articulate that a proportion of patients will not cull CCE in the first identify to avoid the 2nd bowel training in case of positive findings 25 .
Strengths and weaknesses
Our systematic review and meta-analysis has several strengths. It gives an update on the diagnostic accuracy of CCE-2 for polyps ≥ 6 mm and ≥ 10 mm, which includes three (≥ half dozen mm) and four ≥ 10 mm) new studies. Additionally, nosotros conducted stratified analyses based on the indication for CCE-2 and OC examination. Furthermore, we were able to include multiple studies that also analyzed adenomas confirmed by histopathology. An boosted aim of the review was the assessment of the patient perspective, which revealed that clinical trials on CCE-ii and OC take rarely reported the patient perspective in depth.
A full general limitation is the small number of studies that could be included in the meta-assay based on our protocol. In addition, the number of newly published clinical trials is very low (n = 4) since the last meta-assay was published in 2016. The reasons might range from a poor accommodation of the engineering to awaiting the third generation of CCE, the focus on the patient perspective of CCE-2 or the evaluation of the impact of CCE-2 on screening participation. There is a scarcity of studies among unlike populations (boilerplate take a chance, FIT/FOBT + or FDR) that prohibits generalization of our results. Another main limitation of this meta-assay is the heterogeneity of specificities, which was partially controlled by our arroyo using random-effects models. Furthermore, the low number of studies reporting the patient perspective and the heterogenous assessment exercise non let for a clear conclusion on the patient perspective. For more than extensive data on the patient perspective and bowel preparation, separate reviews focusing on those outcomes might be needed.
Decision
In decision, CCE-2 yields advisable diagnostic accuracy for polyps ≥ half dozen mm and ≥ 10 mm in an adequately cleaned large bowel to be implemented in CRC screening. Future studies are needed to elucidate clinical utility with a specific focus on patient perspectives on CCE-2.
Acknowledgments
This piece of work was supported by the German Federal Ministry of Instruction and Research (01KD1907A, 01KD1907B), and the Robert Bosch Stiftung, Stuttgart, Federal republic of germany.
Footnotes
Competing interests The authors declare that they have no conflict of involvement.
Supplementary material
References
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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8041571/
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