Fergus Thursby-Pelham

Endocuff-assisted vs. standard colonoscopy in the fecal occult blood test-based UK Bowel Cancer Screening Programme (E-cap study): a randomized trial

Background and study aims Up to 25 % colorectal adenomas are missed during colonoscopy. The aim of this study was to investigate whether the endocuff could improve polyp detection in an organized bowel cancer screening program (BCSP). Patients and methods This parallel group, single-blinded, randomized controlled trial included patients with positive fecal occult blood test (FOBT) who were attending for BCSP colonoscopy. The primary outcome was the number of polyps per patient. Secondary outcomes included the number of adenomas per patient, adenoma and polyp detection rates, and withdrawal times. Results A total of 534 BCSP patients were randomized to endocuff-assisted or standard colonoscopy. The mean age was 67 years and the male to female ratio was 1.8:1. We detected no significant difference in the number of polyps per patient (standard 1.8, endocuff 1.6; P = 0.44), adenomas per patient (standard 1.4, endocuff 1.3; P = 0.54), polyp detection rate (standard 69.8 %, endocuff 70.3 %; P = 0.93), adenoma detection rate (standard 63.0 %, endocuff 60.9 %; P = 0.85), advanced adenoma detection rate (standard 18.5 %, endocuff 16.9 %; P = 0.81), and cancer detection rate (standard 5.7 %, endocuff 5.3 %; P = 0.85). The mean withdrawal time was significantly shorter among patients in the endocuff group compared with the standard colonoscopy group (16.9 vs. 19.5 minutes; P < 0.005). The endocuff had to be removed in 17/266 patients (6.4 %) because of inability to pass through the sigmoid colon. Conclusions This study did not find improved polyp or adenoma detection with endocuff-assisted colonoscopy in the FOBT-positive BCSP population. A shorter withdrawal time with endocuff may reflect improved views and stability provided by the endocuff.Trial registered at ClinicalTrials.gov (NCT02529007).

A randomized controlled trial of pre-procedure simethicone and N-acetylcysteine to improve mucosal visibility during gastroscopy – NICEVIS

Background and study aims: Mucosal views can be impaired by residual bubbles and mucus during gastroscopy. This study aimed to determine whether a pre-gastroscopy drink containing simethicone and N-acetylcysteine improves mucosal visualisation. Patients and methods: We conducted a randomized controlled trial recruiting 126 subjects undergoing routine gastroscopy. Subjects were randomized 1:1:1 to receive: A—pre-procedure drink of water, simethicone and N-acetylcysteine (NAC); B—water alone; or C—no preparation. Study endoscopists were blinded to group allocation. Digital images were taken at 4 locations (lower esophagus/upper gastric body/antrum/fundus), and rated for mucosal visibility (MV) using a 4-point scale (1 = best, 4 = worst) by 4 separate experienced endoscopists. The primary outcome measure was mean mucosal visibility score (MVS). Secondary outcome measures were procedure duration and volume of fluid flush required to achieve adequate mucosal views. Results: Mean MVS for Group A was significantly better than for Group B (1.35 vs 2.11, P < 0.001) and Group C (1.35 vs 2.21, P < 0.001). Mean flush volume required to achieve adequate mucosal views was significantly lower in Group A than Group B (2.0 mL vs 31.5 mL, P = 0.001) and Group C (2.0 mL vs 39.2 mL P < 0.001). Procedure duration did not differ significantly between any of the 3 groups. MV scores at each of the 4 locations demonstrated significantly better mucosal visibility in Group A compared to Group B and Group C (P < 0.0025 for all comparisons). Conclusions: A pre-procedure drink containing simethicone and NAC significantly improves mucosal visibility during gastroscopy and reduces the need for flushes during the procedure. Effectiveness in the lower esophagus demonstrates potential benefit in Barrett’s oesophagus surveillance gastroscopy.

PTH-039 The First Randomised Controlled Trial of Endocuff Vision® Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients (E-Cap Study): Abstract PTH-039 Table 1

Introduction Up to 25% polyps are missed during colonoscopy. The Endocuff Vision® is a cap with soft flexible arms that attaches to the colonoscope tip and improves views during withdrawal. We have performed the first randomised controlled trial to identify the role of Endocuff Vision® in improving polyp detection. We aim to investigate the impact of Endocuff Vision® assisted colonoscopy on polyp detection, as compared to standard colonoscopy, in the UK Bowel Cancer Screening Programme (BCSP). Methods Single centre, parallel group, randomised controlled trial. Ethics ref: 14/SC/0207. Adopted on UKCRN portfolio (ID: 16985). Patients attending for BCSP colonoscopy were stratified based on attendance for index screening colonoscopy or for polyp surveillance. Within each stratum participants were randomised to either Standard or Endocuff assisted colonoscopy. All procedures were performed by accredited BSCP endoscopists, who have carried out > 5000 colonoscopies and have caecal intubation rates of >90%. Results 534 patients recruited from Sep 2014 to Sep 2015. 3 excluded due to new diagnosis of polyposis syndrome. 531 were included and randomised to the 2 study arms. No significant difference was seen between the 2 groups for the primary endpoint of number of polyps per patient. Secondary endpoints: No significant difference was observed between the 2 groups for adenoma detection rate (ADR) or number of adenomas per patient (Table 1).Abstract PTH-039 Table 1 Standard Endocuff No. participants 265 266 No. of polyps 470 436 Polyps/patient 1.77 1.63 Adenomas 364 343 Adenomas/patient 1.37 1.28 Polyp detection rate 185/265 = 69.8% 187/266 = 70.3% Adenoma detection rate 167/265 = 63% 162/266 = 60.9% Cancer detection rate 15/265 = 5.7% 14/266 = 5.3% No significant adverse events were encountered during the study in either arm. The cecal intubation time was not prolonged and patients did not experience any additional discomfort due to the Endocuff Vision. Conclusion In the UK, bowel cancer screening is performed by highly experienced endoscopists. Our results suggest that in expert hands, ADR exceeds 60% even without Endocuff. In such settings, Endocuff Vision did not improve polyp detection rates (PDR) or ADR. However, it did not cause any adverse events, prolong procedure duration or cause additional discomfort. These data demonstrate the safety and feasibility of Endocuff. However, no additional gain was demonstrated in expert hands. Disclosure of Interest None Declared

PWE-108 Feasibility, Safety and Efficacy of Knife Assisted Resection (KAR) of Rectal Polyps Extending to The Dentate Line: How Low Can You Go?

Introduction Rectal polyps extending to the dentate line (RPDL) pose a technical challenge to endoscopic resection due to the narrow lumen, rich venous/haemorrhoidal plexus and proximity to the skin. Conventional snare EMR is challenging due to the restrcited space and lack of precision with the snare. This has led to the use of surgical techniques like TEMS and TAR for resection of RPDLs. Knife Assisted snare Resection (KAR) allows for precise mucosal incision at the dentate line and the dissection of the polyp from the anorectal junction. We aim to assess the feasibility, safety and efficacy of KAR for RPDLs. Methods This is a prospective observational study of patients who underwent KAR with a mean follow up of 32 months (range 1–83 months). All procedures were done on a day case basis and were carried out under sedation by two endoscopists using high definition gastroscopes with a distal transparent cap. The polyp margin on the anal side was injected with lifting solution consisting of gelofusin, indigo carmine, 1% lignocaine and adrenaline. Haemostasis was maintained using a combination of the endoscopic knife and coag-grasper (Olympus Medical). A mucosal incision was extended around the margins of the polyp, followed by submucosal dissection to facilitate snare deployment to achieve complete polyp resection. Post-procedural antibiotics were not routinely given. Results A total of forty patients (20 female, median age 69 years) underwent KAR for RPDLs over the study period. The polyp characteristics and histology are described in Table 1. The curative resection after a single KAR was achieved in 33 (82.5%) patients. 7 of the 40 patients required further KARs, leading to a total curative resection rate to 97%. The risk factors for multiple resections are polyps measuring >60 mm and encompassing >50% of the circumference (p < 0.01). Overall, there was one complication where the patient had delayed bleeding which was managed conservatively. None of the patients experienced perforation, or post-procedural sepsis.Abstract PWE-108 Table 1 Lesion characteristics and histology Lesion size, median (range), mm 50 (12–150) Morphology, n (%) - LST – G, nodular mixed- LST – G, homogenous- LST – NG- Is 29 (72.5)2 (5)2 (5)7 (17.5) Scarring, n (%) 13 (32.5) Histology, n(%) Adenoma with LGDAdenoma with HGDCancerOther – Condyloma acuminatum 30 (75)6 (15)3 (7.5)1 (2.5) Conclusion This is the largest reported series of KAR for RPDLs. Our data demonstrates that for Western endoscopists, KAR is a very safe and effective technique in the treatment of RPDLs. As KAR is a viable alternative to full ESD, TEMS and TAR, it will play an increasingly significant role in the management of RPDLs. Disclosure of Interest None Declared

PTH-018 Endoclot Prophylaxis Following Complex Endoscopic Resection of Gastrointestinal Neoplasia: No Need to Bleed!

Introduction EMR / ESD of large lesions creates large mucosal defects and is associated with significant post-procedural bleeding. EndoclotTM is a topical hemostatic powder that rapidly absorbs water creating a high concentration of platelets, red blood cells and clotting factors – accelerating the natural coagulation cascade. Routine application of EndoclotTM to ESD or EMR defects is hypothesised to reduce the risk of significant post EMR/ESD bleeding. Methods A prospective registry was set up to record all EMR / ESD procedures since 2006. Prophylactic use of EndoclotTM, following endoscopic resection of lesions >20 mm, to prevent delayed bleeding was introduced in June 2014. The bleeding rate since the introduction of this strategy was compared with the bleed rate of our historic cohort since 2006. Bleeding was defined as significant if it required: readmission, transfusion or further intervention. SPSS was used for statistical analysis of data. Results Pre-Endoclot cohort: 496 patients underwent lower gastrointestinal EMR/ESD at our institution between 2006 and 2013 with a mean polyp size of 43 mm and 12% of these polyps were scarred due to previous intervention. Significant delayed bleeding was seen in 21/496 patients (4%). 264 patients underwent upper gastrointestinal EMR/ESD at our institution between 2006 and 2013. Significant delayed bleeding was seen in 9/264 patients (3%). Endoclot cohort: 71 patients have undergone colonic EMR/ESD (mean polyp size 46 mm, 38% scarred) (Table 1). 61 patients have undergone upper gastrointestinal resection (mean lesion size 33 mm, 37% scarred).Abstract PTH-018 Table 1 Colonic ER Outcomes Mean Lesion Size (mm) Scarring % Delayed Bleeding % Pre-Endoclot n = 496 43 12 4 Post-Endoclot n = 71 46 38 1 P-value NS <0.01 NS There was 1 significant delayed bleed in the colonic group (1%) requiring further endoscopic therapy. There were 2 bleeds (3%) in the upper GI group, which were managed with further endoscopic therapy without the need for blood transfusion. There have been no complications related to EndoclotTM use. Device clogging was experienced in 5% of upper gastrointestinal cases and 15% of lower gastrointestinal cases. Conclusion EndoclotTM shows promise in reducing the risks of delayed bleeding following endoscopic resection of large neoplastic lesions from the gastrointestinal tract. Our data demonstrates a 75% reduction in risk of delayed bleeding following EMR/ESD for large colonic polyps in a group with a significantly higher rate of scarring and therefore bleeding risk. A randomised controlled trial is required to clarify the role of routine use of EndoclotTM following EMR/ESD. Disclosure of Interest None Declared

Tu2087 The first randomised controlled trial of Endocuff Vision® assisted colonoscopy versus standard colonoscopy for polyp detection in bowel cancer screening patients (E-CAP study)

Introduction Up to 25% polyps are missed during colonoscopy. The Endocuff Vision® is a cap with soft flexible arms that attaches to the colonoscope tip and improves views during withdrawal. We have performed the first randomised controlled trial to identify the role of Endocuff Vision® in improving polyp detection. We aim to investigate the impact of Endocuff Vision® assisted colonoscopy on polyp detection, as compared to standard colonoscopy, in the UK Bowel Cancer Screening Programme (BCSP). Methods Single centre, parallel group, randomised controlled trial. Ethics ref: 14/SC/0207. Adopted on UKCRN portfolio (ID: 16985). Patients attending for BCSP colonoscopy were stratified based on attendance for index screening colonoscopy or for polyp surveillance. Within each stratum participants were randomised to either Standard or Endocuff assisted colonoscopy. All procedures were performed by accredited BSCP endoscopists, who have carried out > 5000 colonoscopies and have caecal intubation rates of >90%. Results 534 patients recruited from Sep 2014 to Sep 2015. 3 excluded due to new diagnosis of polyposis syndrome. 531 were included and randomised to the 2 study arms. No significant difference was seen between the 2 groups for the primary endpoint of number of polyps per patient. Secondary endpoints: No significant difference was observed between the 2 groups for adenoma detection rate (ADR) or number of adenomas per patient (Table 1). No significant adverse events were encountered during the study in either arm. The cecal intubation time was not prolonged and patients did not experience any additional discomfort due to the Endocuff Vision. Conclusion In the UK, bowel cancer screening is performed by highly experienced endoscopists. Our results suggest that in expert hands, ADR exceeds 60% even without Endocuff. In such settings, Endocuff Vision did not improve polyp detection rates (PDR) or ADR. However, it did not cause any adverse events, prolong procedure duration or cause additional discomfort. These data demonstrate the safety and feasibility of Endocuff. However, no additional gain was demonstrated in expert hands. Disclosure of Interest None Declared

PTH-020 Large low rectal vs. high rectal polyps: outcome data from a large prospective series

Introduction Low rectal polyps are challenging to resect. We aim to compare safety, feasibility and outcomes of endoscopic resection of low rectal polyps (within 5 cm of dentate line) versus mid to high rectal polyps. Method Cohort study. All patients who had endoscopic resection of rectal polyps >20 mm from 2009 to July 2014 were included. All procedures performed by a single experienced endoscopist. Benign LST-G lesions were resected by conventional EMR technique but polyps close to dentate line, those with scarring, and flat LST-NG lesions were resected either by full ESD or Knife assisted resection technique. Results 181 polyps resected in 179 patients. Avg. patient age 71 years. Mean polyp size 50 mm (20–170 mm). Mean follow up 3 years. Referrals were due to large polyp size, proximity to dentate line or haemorrhoidal bed, scarring or >50% circumference involvement. Polyp characteristics: 61/181(33.7%) >50 mm size, 34/181(18.8%) scarred, 109/181(60.2%) in high rectum and 72/181(39.8%) in low rectum. 110/181(60.8%) resected by ESD and 71/181(39.2%) by EMR. 60/181(33.2%) resected en bloc. Histology showed 8(4.4%) cancers and 27(15%) HGD. There was no significant difference between high and low rectal lesions. Follow up was available for 158. Endoscopic cure rate: 147/158(93%). Of these 124/147(84%) required 1 attempt, 17/147(11.5%) required 2 and 6/147(4.5%) required more than 2 attempts for complete cure. Recurrence/residual polyp after first attempt seen in 30/158 (19%) of patients. Univariate analysis showed that recurrence was significantly linked to size >50 mm, piecemeal resection, low rectal lesions and scarring (Table 1).Abstract PTH-020 Table 1 Factors associated with recurrence Size Resection type Site Scarring Recurrence ≤50 mm >50 mm En bloc Piecemeal High rectum Low rectum Yes No 30/158 (19%) 13/108 (12%) p=0.001 17/50 (34%) 3/57 (5.2%) p=0.001 27/101 (26.7%) 13/93 (14%) p=0.05 17/65 (26.1%) 11/28 (39.3%) p=0.003 19/130 (14.6%) The complication rate was 14/181(7.7%) which were all managed conservatively. There was 1(0.5%) significant intraprocedural bleed. There were 7(3.9%) delayed bleeds (2 needing transfusion), 1(0.5%) post polypectomy syndrome and 5(2.7%) cases of exposed muscle fibres clipped during the procedure with no further sequelae. There were no factors significantly predictive of complications. Conclusion Rectal polyps referred for resection are generally very large (mean 50 mm). It is safe and feasible to resect very low rectal polyps around the dentate line. We found no difference in complication rates between low and high rectal polyps. Given large sizes and rectal location, the low cancer rate reflects our careful lesion selection. Recurrence is higher in low rectal polyps and those with large size and scarring. However, repeat attempts can achieve complete clearance. Disclosure of interest None Declared.

PTH-009 Nicevis – results of a randomised controlled trial of simeticone and n-acetylcysteine as a pre-procedure drink to improve mucosal visibility during diagnostic gastroscopy

Introduction Despite advances in endoscope technology there is still a significant miss rate of neoplastic lesions during gastroscopy. Mucosal views are frequently impaired by residual bubbles and mucus. Method We conducted an RCT in 126 patients attending for routine gastroscopy. Subjects were randomised in a 1:1:1 ratio to receive a pre-procedure drink of water, simeticone and n-acetylcysteine (Group A), water alone (Group B) or no preparation (Group C). Study endoscopists were blinded to group allocation. 4 digital images were taken at pre-defined locations during the procedure – lower oesophagus, upper body, antrum and fundus. Images were rated for mucosal visibility (MV) using a 4 point scale (1 = best, 4 = worst) by 4 blinded experienced endoscopists. Primary outcome measure was mean MV score. Secondary outcome measures were procedure duration and volume of flush required to achieve adequate mucosal views. Results Groups were well matched for age, gender or indication for endoscopy. Mean MV score for group A was significantly better than for group B and group C (p < 0.001 for both comparisons), with no significant difference between groups B and C (p = 0.541). Interobserver agreement of MV scores was good (mean kappa 0.464). Mean volume of flush required to achieve adequate mucosal views was significantly lower in group A than group B (p = 0.001), and group C (P < 0.001). There was no significant difference in mean flush volume between groups B and C (p = 0.583). Procedure duration did not differ significantly between the groups. Subgroup analysis of MV scores at each location demonstrated significantly better mucosal visibility in group A compared to group B and group C at all locations (p < 0.0025 for all comparisons).Abstract PTH-009 Table 1 Group A – simeticone/NAC B – water C – No preparation Mean Mucosal Visibility (MV) Score (range 1–4) 1.35 2.11 2.21 Mean Procedure duration (sec) 309 352 334 Mean Volume of flush (ml) 2.0 31.5 39.2 Conclusion A pre-procedure drink containing simeticone and n-acetlycysteine significantly improves mucosal visibility during routine gastroscopy and reduces the need for flushes during the procedure. This may improve detection of early neoplasia and other pathology during gastroscopy. Subanalysis of separate locations demonstrates significant benefit in the lower oesophagus, demonstrating potential benefit in Barrett’s surveillance procedures. Disclosure of interest None Declared.

Sa1458 Nicevis - Results of a Randomised Controlled Trial of Simeticone and N-Acetylcysteine As a Pre-Procedure Drink to Improve Mucosal Visibility During Diagnostic Gastroscopy

Introduction: Despite advances in endoscope technology there is still a significant miss rate of neoplastic lesions during gastroscopy. Mucosal views are frequently impaired by residual bubbles and mucus. Method: We conducted an RCT in 126 patients attending for routine gastroscopy. Subjects were randomised in a 1:1:1ratio to receive a pre-procedure drink of water, simeticone and n-acetylcysteine (Group A), water alone (Group B) or nopreparation (Group C). Study endoscopists were blinded to group allocation. 4 digital images were taken at pre-defined locations during the procedure – lower oesophagus, upper body, antrum & fundus. Images were rated for mucosalvisibility (MV) using a 4 point scale (1 = best, 4 = worst) by 4 blinded experienced endoscopists. Primary outcome measure was mean MV score. Secondary outcome measures were procedure duration and volume of flush required to achieve adequate mucosal views. Results: Groups were well matched for age, gender or indication for endoscopy. Mean MV score for group A was significantly better than for group B and group C (p < 0.001 for both comparisons), with no significant difference between groups B and C (p=0.541). Interobserver agreement of MV scores was good (mean kappa 0.464).Mean volume of flush required to achieve adequate mucosal views was significantly lower in group A than group B(p=0.001), and group C (P<0.001). There was no significant difference in mean flush volume between groups B & C(p=0.583). Procedure duration did not differ significantly between the groups.Subgroup analysis of MV scores at each location demonstrated significantly better mucosal visibility in group A compared to group B and group C at all locations (p<0.0025 for all comparisons).Group A -Simeticone/NACB –WaterC – Nopreparation Mean Mucosal Visibility (MV) Score(range 1-4)1.35 2.11 2.21Mean Procedure duration (sec) 309 352 334Mean Volume of flush (ml) 2.0 31.5 39.2 Conclusion: A pre-procedure drink containing simeticone and n-acetlycysteine significantly improves mucosal visibility during routine gastroscopy and reduces the need for flushes during the procedure. This may improve detection of early neoplasia and other pathology during gastroscopy. Subanalysis of separate locations demonstrates significant benefit inthe lower oesophagus, demonstrating potential benefit in Barrett’s surveillance procedures.

Tips for GP trainees working in gastroenterology.

An ST placement on a gastroenterology firm can be a valuable experience for a GP trainee. You will be exposed to patients with many conditions commonly seen in general practice such as inflammatory bowel disease (IBD), peptic ulcer disease, upper GI cancer, and complications of cirrhosis. As in primary care a significant proportion of the work is related to diseases caused by excess alcohol consumption and this is on the rise. Gastroenterology inpatients are often sick and have complex medical needs. Many patients will have a very poor prognosis or terminal disease so you will work frequently with palliative care services and care for dying patients. Young patients with IBD often need further explanations, information, and a chance to express anxieties following a busy consultant ward round. Your role in this regard can be invaluable. Gastroenterology jobs tend to be busy but you will learn lots and develop many skills along the way. Here are a few tips to help you get started. 1. Ensure the surgical team is aware of all patients admitted with severe colitis. If medical treatment fails they may require a colectomy, so it’s best the surgeons are aware of them in advance. 2. Ensure any patient with Crohn’s disease has had a proper perianal examination: …