ABSTRACT
BACKGROUND AND AIMS: Intestinal and anastomotic strictures in Crohn's disease (CD) produce considerable morbidity. The development of surgery-sparing, endoscopic modalities for stricture resolution is essential. Removable stent therapy is emerging as an efficacious and safe means of stricture resolution. We present outcomes from the largest, single-center series of patients with CD undergoing removable self-expanding metal stent (SEMS) therapy to resolve focal intestinal strictures. METHODS: Patients with symptomatic CD were assessed with magnetic resonance enterography. Short (≤6 cm), fibrostenotic strictures of the terminal ileum or ileocolonic anastomoses were considered by a multidisciplinary team and put forward for stent therapy. Strictures were examined endoscopically and impassable strictures were treated with SEMSs. The Hanaro HRC-20-080-230 partially covered SEMS was used for all patients. Endoscopically inaccessible or inflammatory strictures were excluded. Stent retrieval was scheduled for 7 days after insertion. Therapeutic benefit was assessed with validated inflammatory bowel disease scoring tools. RESULTS: Twenty-one patients underwent 23 stent episodes, with 2 patients requiring repeat therapy in the follow-up period. Most treated strictures were anastomotic (19 of 21); 2 of 21 were de novo. Of those patients attending follow-up, 81% (13 of 16) reported symptom improvement or resolution; 88% (14 of 16) were in clinical remission at follow-up. Across all stent episodes, only 5 adverse events were noted (2 episodes of stent-related discomfort, 3 asymptomatic stent migrations). There were no direct stent-related adverse events such as perforation, impaction, or bleeding. No patient has required stricture-related surgery in the follow-up period (range, 3-50 months). CONCLUSIONS: In this series, removable SEMS therapy for ileal and anastomotic strictures was found to be clinically efficacious. The absence of perforation events and need for stricture-related surgery are noteworthy. These results suggest that the efficacy of stent therapy in this context merits powered, head-to-head investigation with other modalities for stricture resolution.
Subject(s)
Crohn Disease , Constriction, Pathologic/etiology , Constriction, Pathologic/surgery , Crohn Disease/complications , Humans , Retrospective Studies , Stents , Treatment Outcome , United KingdomABSTRACT
PURPOSE: Clinical trials have demonstrated efficacy of vedolizumab in ulcerative colitis (UC) and Crohn's disease (CD). Further real-world data is needed to inform clinical practice. The primary outcome was to assess corticosteroid-free and clinical remission after vedolizumab initiation. Secondary outcomes included effect on disease activity scores, biochemical markers, concomitant drug use, endoscopic remission, surgical intervention, hospital admissions and adverse events. MATERIALS AND METHODS: A multi-centre retrospective observational study was conducted with patients initiated on vedolizumab across seven UK hospitals 1/11/14-30/11/16. Clinical disease activity was assessed using the partial Mayo Scores (pMS) and Harvey Bradshaw Index (HBI). Clinical remission was defined as HBI ≤4 or pMS <2 with a combined stool frequency and rectal bleeding sub score of ≤1. Clinical response was defined as ≥2-point decrease from baseline in pMS and ≥3-point decrease from baseline in HBI. RESULTS: One hundred ninety-two patients were included in the final analysis. 45% of UC and 10% of CD patients were anti-TNF naive. Over the observation period corticosteroid-free remission rates for UC and CD were 46% and 45%, while clinical remission rates were 52% and 44%, respectively. Time to corticosteroid free remission for UC and CD was 17.6 [IQR: 8.7-29.6] and 14.1 [QR: 6.0-21.7] weeks, respectively. Time to clinical response for UC was 9.4 [IQR: 5.7-15.4] and CD was 9.5 [IQR: 6.1-18.2] weeks. There was a substantial decrease in the concomitant use of immunomodulators and a similar decrease in concomitant corticosteroid use over the study period. CONCLUSIONS: Results in this predominately anti-TNF experienced population mirror other published real-world data, demonstrating good clinical effectiveness and a comparable safety profile.
Subject(s)
Antibodies, Monoclonal, Humanized , Colitis, Ulcerative , Inflammatory Bowel Diseases , Antibodies, Monoclonal, Humanized/therapeutic use , Colitis, Ulcerative/drug therapy , Gastrointestinal Agents/therapeutic use , Humans , Inflammatory Bowel Diseases/drug therapy , Tumor Necrosis Factor Inhibitors , United KingdomABSTRACT
BACKGROUND: Although conventional colonoscopy is the most accurate test available for the investigation of the colorectum for polyps, data exist that raise concerns about its sensitivity. Chromoscopy (spraying dye onto the surface of the colon to make polyps more visible) may be one way of enhancing the ability of colonoscopy to detect polyps, particularly diminutive flat lesions, which otherwise may be difficult to detect. OBJECTIVES: To determine whether the use of chromoscopy enhances the detection of polyps and neoplasia during endoscopic examination of the colon and rectum. SEARCH METHODS: We searched the following databases: Cochrane Colorectal Cancer Group Specialised Register (October 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library; Issue 10, 2015), MEDLINE (January 1950 to October 2015), EMBASE (January 1974 to October 2015), and ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (both November 2015). We also handsearched abstracts from relevant meetings from 1980 to 2015. Search terms included 'randomised trials' containing combinations of the following: 'chromoscopy' 'colonoscopy' 'dye-spray' 'chromo-endoscopy' 'indigo-carmine' 'magnifying endoscopy'. SELECTION CRITERIA: We included all prospective randomised trials comparing chromoscopic with conventional endoscopic examination of the whole of the colon and rectum. We excluded studies of people with inflammatory bowel disease or polyposis syndromes and any studies that combined chromoscopy with additional interventions (cap assistance, water-perfused, etc.). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the methodological quality of potentially eligible trials, and two review authors independently extracted data from the included trials. Outcome measures included the detection of polyps (neoplastic and non-neoplastic), the detection of diminutive lesions, the number of participants with multiple neoplastic lesions, and the extubation time. MAIN RESULTS: We included seven trials (2727 participants) in this update. Five trials were of sufficiently similar design to allow for pooled results. Two trials differed substantially in design and were included in a subgroup analysis. All the trials had some methodological drawbacks. However, combining the results showed a significant difference in favour of chromoscopy for all detection outcomes. In particular, chromoscopy was likely to yield significantly more people with at least one neoplastic lesion (odds ratio (OR) 1.53, 95% confidence interval (CI) 1.31 to 1.79; 7 trials; 2727 participants), and at least one diminutive neoplastic lesion (OR 1.51, 95% CI 1.19 to 1.92; 4 trials; 1757 participants). Significantly more people with three or more neoplastic lesions were also detected, but only when studies that used high-definition colonoscopy in the control group were excluded (OR 4.63, 95% CI 1.99 to 10.80; 2 trials; 519 participants). None of the included studies reported any adverse events related to the use of the contrast dye. AUTHORS' CONCLUSIONS: There is strong evidence that chromoscopy enhances the detection of neoplasia in the colon and rectum. People with neoplastic polyps, particularly those with multiple polyps, are at increased risk of developing colorectal cancer. Such lesions, which presumably would be missed with conventional colonoscopy, could contribute to the interval cancer numbers on any surveillance programme.
Subject(s)
Colonoscopy/methods , Indicators and Reagents , Indigo Carmine , Intestinal Polyps/diagnosis , Rectal Diseases/diagnosis , Colonic Polyps/diagnosis , Humans , Precancerous Conditions/diagnosis , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Cold snare techniques are widely used for removal of diminutive and small colorectal polyps. The influence of resection technique on the effectiveness of polypectomy is unknown. We therefore compared standard cold snare polypectomy with a newly described suction pseudopolyp technique, for completeness of excision and for complications. PATIENTS AND METHODS: In this single-center study, 112 patients were randomized to cold snare polypectomy or the suction pseudopolyp technique. Primary outcome was endoscopic completeness of excision. Consensus regarding the endoscopic assessment of completeness of excision was standardized and aided by chromoendoscopy. Secondary outcomes included: completeness of histological excision, polyp "fly away" and retrieval rates, early bleeding (48 hours), delayed bleeding (2 weeks), and perforation. RESULTS: 148 polyps were removed, with size range 3â-â7âmm, 60â% in the left colon, and 90â% being sessile. Regarding completeness of excision (with uncertain findings omitted): endoscopically, this was higher with the suction pseudopolyp technique compared with cold snare polypectomy but not statistically significantly so (73/74 [98.6â%] vs. 63/68 [92.6â%]; Pâ=â0.08). A trend towards a higher complete histological excision rate with the suction pseudopolyp technique was also not statistically significant (45/59 [76.3â%] vs. 37/58 [63.8â%]; Pâ=â0.14). Polyp retrieval rate was not significantly different (suction 68/76 [89.5â%] vs. cold snare 64/72 [88.9â%]; Pâ=â0.91). No perforation or bleeding requiring hemostasis occurred in either group.â CONCLUSION: In this study both polypectomy techniques were found to be safe and highly effective, but further large multicenter trials are required.Clinical trial registration at www.clinicaltrials.gov: NCT02208401.
Subject(s)
Adenomatous Polyps/surgery , Colonoscopy/methods , Colorectal Neoplasms/surgery , Intestinal Polyps/surgery , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Prospective Studies , Single-Blind Method , Suction , Treatment OutcomeABSTRACT
BACKGROUND: Most colonic polyps are small, and several polypectomy techniques are available. We aimed to describe the variation in polypectomy techniques employed for the removal of sub-centimeter polyps in relation to polyp characteristics, completeness of histological excision and safety. METHODS: Prospectively collected data relating to the removal of sub-centimeter polyps over a 3-year period (between January 2010 and December 2012) were retrieved from the English Bowel Cancer Screening Programme. RESULTS: A total of 147,174 sub-centimeter polyps were removed during 62,679 procedures. For pedunculated polyps, hot snare was most common in the left (median 92 %, IQR 83.3-97.0 %) and right colon (median 75 %, IQR 3-92 %). For non-pedunculated polyps, cold snare was most common in the right colon (median 24 %, IQR 9-47 %); whereas hot snare remained most common in the left colon (median 32 %, IQR 19-49 %). Surgeons were more likely than physicians to use diathermy-assisted techniques (65.6 vs. 56.5 %, p < 0.001). Twelve (0.03 %) bleeding episodes required transfusion with no polypectomy technique dominating and 16 (0.04 %) perforations with 81 % of polypectomies performed using diathermy-assisted techniques. There was substantial variation between screening centers for the completeness of histological excision. For non-pedunculated polyps, histologically confirmed complete excision was more after EMR (23.4 %) compared with other techniques (cold biopsy forceps 17.7 %, cold snare 15.1 %, hot biopsy forceps 19.1 %, hot snare 21.5 %). The use of cold techniques and EMR has increased over time, whereas the use of hot biopsy forceps and hot snare has decreased (p < 0.001). CONCLUSIONS: The removal of sub-centimeter polyps within the BCSP is safe despite wide variations in practice. The use of cold resection techniques and EMR has increased over time. The histological assessment for completeness of excision is limited and should be confirmed endoscopically at the time of polypectomy.
Subject(s)
Colonic Neoplasms/diagnosis , Colonic Polyps/surgery , Colonoscopy/methods , Early Detection of Cancer , Aged , Aged, 80 and over , Colonic Polyps/diagnosis , Female , Humans , Male , Middle Aged , United KingdomABSTRACT
BACKGROUND AND AIM: Cold snare techniques are widely used for the removal of small and diminutive polyps. The influence of snare type on the effectiveness of cold snare polypectomy is unknown. METHODS: Cold snare polypectomy of 3-7-mm polyps was undertaken using either a thin wire mini-snare (0.30 mm) or a thick wire mini-snare (0.47 mm). Primary outcome was endoscopic completeness of excision. Consensus regarding endoscopic assessment of completeness of excision was standardized and aided by chromoendoscopy. Secondary outcomes included: completeness of histological excision, polyp 'fly away', polyp retrieval rate, early or delayed bleeding and perforation. RESULTS: One hundred and fifty-seven polyps were removed ranging from 3 to 7 mm, 62% were situated in the left side of the colon and 89.4% were sessile. Endoscopic completeness of excision was significantly higher with the thin wire snare compared to the thick wire snare (90.2% vs 73.3%, P < 0.05). There was a numerical trend towards a higher complete histological excision rate with the thin wire snare, but this did not reach statistical significance (73.3% vs 65.2%, P = 0.4). There was a fair level of agreement (kappa = 0.36) between endoscopic and histological completeness of excision. Polyp 'fly away' occurred less often with the thin wire snare (14.6% vs 35.3%, P = 0.002), but there was no significant difference in polyp retrieval rate (84.3% vs 83.8%, P = 0.94). There were no complications with either snare. CONCLUSION: Snare type appears to be an important determinant of completeness of excision when removing small polyps by the cold snare technique.
Subject(s)
Colonic Polyps/surgery , Colonoscopy/methods , Microsurgery/methods , Postoperative Complications/prevention & control , Adult , Aged , Aged, 80 and over , Colonic Polyps/diagnosis , Confidence Intervals , Female , Humans , Incidence , Male , Middle Aged , Postoperative Complications/epidemiology , Retrospective Studies , Treatment Outcome , United Kingdom/epidemiologyABSTRACT
INTRODUCTION: In the past 5 years, there have been several advances in the management of inflammatory bowel disease (IBD). We aim for a new guideline to update the most recent guideline published in 2019. We present the prospective operating procedure and technical summary protocol in the manuscript. METHODS: 'Grading of Recommendations Assessment, Development and Evaluation' (GRADE) will be followed in the development of the guideline, approach as laid out in the GRADE handbook, supported by the WHO. The guideline development group is formed by a variety of disciplines, across both primary and secondary care that took part in an online Delphi process and split into key areas. A final consensus list of thematic questions within a 'patient, intervention, comparison, outcome' format has been produced and agreed in the final phase of the Delphi process.There will be a detailed technical evidence review with source data including systematic reviews appraised with AMSATAR 2 tool (Assessment of multiple systematic reviews), randomised controlled trial data that will be judged for risk of bias with the Cochrane tool and observational studies for safety concerns assessed through the Robins-I tool. Based on the available evidence, some of the recommendations will be based on GRADE while others will be best practice statements.A full Delphi process will be used to make recommendations using online response systems.This set of procedures has been approved by the Clinical Services and Standards Committee, the British Society of Gastroenterology executive board and aligned with IBD UK standards.
Subject(s)
Inflammatory Bowel Diseases , Humans , Prospective Studies , Delivery of Health Care , Randomized Controlled Trials as TopicABSTRACT
Introduction: In the UK, endoscopy certification is awarded when trainees attain minimum competency standards for independent practice. A national evidence-based review was undertaken to update and develop standards and recommendations for colonoscopy training and certification. Methods: Under the oversight of the Joint Advisory Group (JAG), a modified Delphi process was conducted between 2019 and 2020 with multisociety expert representation. Following literature review and Grading of Recommendations, Assessment, Development and Evaluations appraisal, recommendation statements on colonoscopy training and certification were formulated and subjected to anonymous voting to obtain consensus. Accepted statements were peer reviewed by JAG and relevant stakeholders for incorporation into the updated colonoscopy certification pathway. Results: In total, 45 recommendation statements were generated under the domains of: definition of competence (13), acquisition of competence (20), assessment of competence (8) and postcertification support (4). The consensus process led to revised criteria for colonoscopy certification, comprising: (1) achieving key performance indicators defined within British Society of Gastroenterology standards (ie, unassisted caecal intubation rate >90%, rectal retroversion >90%, polyp detection rate >15%+, polyp retrieval rate >90%, patient comfort <10% with moderate-severe discomfort); (2) minimum procedure count 280+; (3) performing 15+ procedures over the preceding 3 months; (4) attendance of the JAG Basic Skills in Colonoscopy course; (5) terminal ileal intubation rates of 60%+ in inflammatory bowel disease; (6) satisfying requirements for formative direct observation of procedure skills (DOPS) and direct observation of polypectomy skills (Size, Morphology, Site, Access (SMSA) level 2); (7) evidence of reflective practice as documented on the JAG Endoscopy Training System reflection tool; (8) successful performance in summative DOPS. Conclusion: The UK standards for training and certification in colonoscopy have been updated, culminating in a single-stage certification process with emphasis on polypectomy competency (SMSA Level 2+). These standards are intended to support training, improve standards of colonoscopy and polypectomy, and provide support to the newly independent practitioner.
ABSTRACT
Introduction: Joint Advisory Group (JAG) certification in endoscopy is awarded when trainees attain minimum competency standards for independent practice. A national evidence-based review was undertaken to update standards for training and certification in flexible sigmoidoscopy (FS). Methods: A modified Delphi process was conducted between 2019 and 2020 with multisociety representation from experts and trainees. Following literature review and Grading of Recommendations, Assessment, Development and Evaluations appraisal, recommendation statements on FS training and certification were formulated and subjected to anonymous voting to obtain consensus. Accepted statements were peer-reviewed by national stakeholders for incorporation into the JAG FS certification pathway. Results: In total, 41 recommendation statements were generated under the domains of: definition of competence (13), acquisition of competence (17), assessment of competence (7) and postcertification support (4). The consensus process led to revised criteria for colonoscopy certification, comprising: (A) achieving key performance indicators defined within British Society of Gastroenterology standards (ie, rectal retroversion >90%, polyp retrieval rate >90%, patient comfort <10% with moderate-severe discomfort); (B) minimum procedure count ≥175; (C) performing 15+ procedures over the preceding 3 months; (D) attendance of the JAG Basic Skills in Lower gastrointestinal Endoscopy course; (E) satisfying requirements for formative direct observation of procedural skill (DOPS) and direct observation of polypectomy skill (SMSA level 1); (F) evidence of reflective practice as documented on the JAG Endoscopy Training System reflection tool and (G) successful performance in summative DOPS. Conclusion: The UK standards for training and certification in FS have been updated to support training, uphold standards in FS and polypectomy, and provide support to the newly independent practitioner.
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BACKGROUND: Whilst polyp size has been traditionally used as a predictor of the complexity of endoscopic resection, the influence of other factors is increasingly recognised. The SMSA grading system takes into account polyp Site, Morphology, Size and Access, with higher scores correlating with increased technical difficulty. AIMS: To evaluate whether the SMSA grading tool correlates with endoscopic and clinical outcomes. METHODS: This retrospective study was conducted at two high volume centres in the United Kingdom and Italy. All polyps identified at colonoscopy were included in this study and classified as per the SMSA grading system. RESULTS: A total of 1668 lesions were resected in 1016 patients. There was a positive correlation between increasing SMSA level and the inability to resect lesions "en bloc" (p<0.001). Histologically complete clearance was higher in the lower SMSA groups (p<0.0001). Additional endoscopic therapies, were more commonly required with the higher SMSA groups to achieve histological clearance (p<0.0001). Moreover, advanced histology in resection specimens and procedural complications were significantly less common in SMSA level 1 lesions compared to level 3 or 4 lesions (p<0.0001). CONCLUSIONS: The SMSA grading tool is a useful predictor of outcome following the resection of colonic neoplastic lesions.
Subject(s)
Colonic Polyps/pathology , Colonic Polyps/surgery , Colorectal Neoplasms/pathology , Adult , Aged , Aged, 80 and over , Colonic Polyps/diagnosis , Colonoscopy , Colorectal Neoplasms/diagnosis , Female , Humans , Italy , Logistic Models , Male , Middle Aged , Retrospective Studies , Severity of Illness Index , United KingdomABSTRACT
BACKGROUND AND STUDY AIMS: Entonox is a 50 : 50 combination of nitrous oxide and oxygen, which may be used to manage pain during colonoscopy. The optimal mode of Entonox administration is unknown. The aim of this study was therefore to compare continuous and as-required Entonox use. PATIENTS AND METHODS: Patients attending for screening colonoscopy at a single centre were randomized to continuous or as-required Entonox use. The primary outcome measure was the patient's overall pain rating at the time of discharge (verbally administered numerical ratings scale, 0=no pain and 10=extreme pain). Secondary outcome measures included the patients' experience of pain during the colonoscopy (rated every 2 min), side effects and the need for rescue intravenous medications. RESULTS: A total of 108 patients were randomized, and 100 completed the study (46 continuous, 54 as required). The overall pain scores at discharge did not differ between those who used Entonox continuously and as required (mean=2.4 vs. 3.2, P=0.08). There were also no differences in the experience of pain during colonoscopy (mean=1.8 vs. 2.2, P=0.28; peak=4.2 vs. 4.8, P=0.26; and area under curve=23 vs. 30, P=0.24). Patients with high anxiety had greater overall pain scores (mean=3.7 vs. 2.4, P=0.03). Light headedness occurred more often with continuous Entonox use (48 vs. 21%, P=0.009). CONCLUSION: Among patients attending for screening colonoscopy, comfort ratings were similar in those using Entonox continuously and as required, but light headedness was more common with continuous use (NCT identifier: 01865721).