A guide for assessing the clinical relevance of findings in small bowel capsule endoscopy: analysis of 8064 answers of international experts to an illustrated script questionnaire.

BACKGROUND AND AIM: Although recommended, the P-score used for assessing the pertinence / relevance of findings seen in small bowel (SB) capsule endoscopy (CE) is based on a low level of knowledge. The aim of this study was to evaluate the clinical relevance of the most frequent SBCE findings through an illustrated script questionnaire. MATERIALS AND METHODS: Sixteen types of SBCE findings were illustrated four times each in three different settings (occult and overt obscure gastrointestinal bleeding and suspected Crohn's disease), and with a variable number (n = 1/n = 2-5/n ≥ 6), thus providing a questionnaire with 192 scenarios and 576 illustrated questions. Fifteen international experts were asked to rate the finding's relevance for each question as very unlikely (-2) / unlikely (-1) / doubtful (0) / likely (+1) / very likely (+2). The median score (≤-0.75, between -0.75 and 0.75, or ≥0.75) obtained for each scenario determined a low (P0), intermediate (P1) or high (P2) relevance, respectively. RESULTS: 8064 answers were analyzed. Participation and completion rates were 93% and 100%, respectively. In overt or occult OGIB, resultant P2 findings were 'typical angiectasia', 'deep ulceration', 'stenosis', and'blood', whatever their numbers, and 'superficial ulcerations' when multiple. While in suspected CD, consensus P2 lesions were 'deep ulceration' and 'stenosis' whatever their numbers, and 'aphthoid erosions' and 'superficial ulcerations' when multiple. CONCLUSION: This study establishes a guide for the evaluation of relevance of SBCE findings. It represents a step forward for SB-CE interpretation and is intended to be used as a tool for teaching and academic research.

Resect and discard strategy in clinical practice: a prospective cohort study.

BACKGROUND AND STUDY AIMS: Narrow-band imaging (NBI) has shown promising results in discriminating adenomatous from non-adenomatous colonic polyps. In patients with small polyps (< 10  mm), the application of NBI within a "resect and discard" strategy, might allow post-polypectomy surveillance intervals to be determined independently from histopathology. The aim of the present study was to assess the feasibility and safety of this approach in routine clinical practice. PATIENTS AND METHODS: Consecutive colonoscopy outpatients with one or more polyps smaller than 10  mm were prospectively included. Each polyp was categorized by the endoscopist as adenoma or non-adenoma according to simplified NBI criteria, and future post-polypectomy surveillance interval was assigned accordingly. Following histopathology, post-polypectomy surveillance interval was subsequently re-assigned, and the accordance between endoscopy- and histology-directed surveillance strategies was calculated. RESULTS: Among 942 colonoscopy patients, 286 (30.4 %) with only small polyps were included. In total, 511 small polyps were evaluated; 350 (68.5 %) were adenomas and 18 of these (5.1 %) had histologic features of advanced neoplasia. For the in vivo diagnosis of adenoma, NBI sensitivity, specificity, accuracy, and positive and negative likelihood ratios were 94.9 %, 65.8 %, 85.7 %, 2.80, and 0.08, respectively. The endoscopy-directed surveillance strategy was in accordance with the histology-directed strategy in 237 of 286 patients (82.9 %). In 9.8 % and 7.3 % patients, the endoscopy-directed approach would have resulted in early and delayed surveillance, respectively. CONCLUSIONS: The resect and discard strategy seems to be a viable, safe, and cost-effective approach for the management of patients with small polyps. However, caution in the application of the strategy should be advocated for patients with polyps 6 - 9  mm in size and those with right-sided lesions, due to their malignant potential. The study was registered on Clinicaltrials.gov (NCT01462123).

Colon capsule endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

PillCam colon capsule endoscopy (CCE) is an innovative noninvasive, and painless ingestible capsule technique that allows exploration of the colon without the need for sedation and gas insufflation. Although it is already available in European and other countries, the clinical indications for CCE as well as the reporting and work-up of detected findings have not yet been standardized. The aim of this evidence-based and consensus-based guideline, commissioned by the European Society of Gastrointestinal Endoscopy (ESGE) is to furnish healthcare providers with a comprehensive framework for potential implementation of this technique in a clinical setting.

Role of small-bowel endoscopy in the management of patients with inflammatory bowel disease: an international OMED-ECCO consensus.

Crohn's disease and ulcerative colitis are lifelong diseases seen predominantly in the developed countries of the world. Whereas ulcerative colitis is a chronic inflammatory condition causing diffuse and continuous mucosal inflammation of the colon, Crohn's disease is a heterogeneous entity comprised of several different phenotypes, but can affect the entire gastrointestinal tract. A change in diagnosis from Crohn's disease to ulcerative colitis during the first year of illness occurs in about 10 % - 15 % of cases. Inflammatory bowel disease (IBD) restricted to the colon that cannot be characterized as either ulcerative colitis or Crohn's disease is termed IBD-unclassified (IBDU). The advent of capsule and both single- and double-balloon-assisted enteroscopy is revolutionizing small-bowel imaging and has major implications for diagnosis, classification, therapeutic decision making and outcomes in the management of IBD. The role of these investigations in the diagnosis and management of IBD, however, is unclear. This document sets out the current Consensus reached by a group of international experts in the fields of endoscopy and IBD at a meeting held in Brussels, 12-13th December 2008, organised jointly by the European Crohn's and Colitis Organisation (ECCO) and the Organisation Mondiale d'Endoscopie Digestive (OMED). The Consensus is grouped into seven sections: definitions and diagnosis; suspected Crohn's disease; established Crohn's disease; IBDU; ulcerative colitis (including ileal pouch-anal anastomosis [IPAA]); paediatric practice; and complications and unresolved questions. Consensus guideline statements are followed by comments on the evidence and opinion. Statements are intended to be read in context with qualifying comments and not read in isolation.

Small-bowel neoplasms in patients undergoing video capsule endoscopy: a multicenter European study.

BACKGROUND AND STUDY AIM: Small-bowel tumors account for 1% - 3% of all gastrointestinal neoplasms. Recent studies with video capsule endoscopy (VCE) suggest that the frequency of these tumors may be substantially higher than previously reported. The aim of the study was to evaluate the frequency, clinical presentation, diagnostic/therapeutic work-up, and endoscopic appearance of small-bowel tumors in a large population of patients undergoing VCE. PATIENTS AND METHODS: Identification by a questionnaire of patients with VCE findings suggesting small-bowel tumors and histological confirmation of the neoplasm seen in 29 centers of 10 European Countries. RESULTS: Of 5129 patients undergoing VCE, 124 (2.4%) had small-bowel tumors (112 primary, 12 metastatic). Among these patients, indications for VCE were: obscure gastrointestinal bleeding (108 patients), abdominal pain (9), search for primary neoplasm (6), diarrhea with malabsorption (1). The main primary small-bowel tumor type was gastrointestinal stromal tumor (GIST) (32%) followed by adenocarcinoma (20%) and carcinoid (15%); 66% of secondary small-bowel tumors were melanomas. Of the tumors, 80.6% were identified solely on the basis of VCE findings. 55 patients underwent VCE as the third procedure after negative bidirectional endoscopy. The lesions were single in 89.5% of cases, and multiple in 10.5%. Retention of the capsule occurred in 9.8% of patients with small-bowel tumors. After VCE, 54/124 patients underwent 57 other examinations before treatment; in these patients enteroscopy, when performed, showed a high diagnostic yield. Treatment was surgery in 95% of cases. CONCLUSIONS: Our data suggest that VCE detects small-bowel tumors in a small proportion of patients undergoing this examination, but the early use of this tool can shorten the diagnostic work-up and influence the subsequent management of these patients.

Use of the Given Patency System for the screening of patients at high risk for capsule retention.

BACKGROUND: Capsule enteroscopy is a non-invasive diagnostic tool for the study of the small bowel. Due to the risk of capsule retention, capsule enteroscopy is contraindicated in patients with suspected small bowel strictures. The Given Patency Capsule is a disintegration time-controlled capsule developed to identify patients with strictures that may cause capsule enteroscopy retention. The presence of the patency capsule within the patient's body can be detected by a radio-frequency scanner. AIM OF THE STUDY: To evaluate safety and usefulness of the patency capsule in preventing capsule retention in patients at high risk. PATIENTS AND METHODS: Thirty-two patients were studied. Indications for patency capsule were: (A) Crohn's disease (18), (B) previous intestinal surgery (7), (C) previous obstruction (1), A+B (3), A+C (1), B+C (2). Patients were evaluated with the scanner at 72 h from ingestion. RESULTS: At 72 h, 24 patients had already excreted the intact capsule in the stool. Of these, two experienced abdominal pain during capsule passage. In the other eight patients, the scanner detected the presence of the patency capsule. Four of them excreted the capsule intact in the stool after 72-96 h, the remaining four never found the capsule in the stool. The 26 patients who excreted the patency capsule intact without experiencing abdominal pain were deemed eligible for the capsule enteroscopy procedure, which was performed uneventfully in the 25 who agreed to undergo the examination. CONCLUSIONS: The patency capsule is useful to identify, among patients at high risk, those who can be submitted to capsule enteroscopy without risks of capsule retention.

The accuracy of PillCam ESO capsule endoscopy versus conventional upper endoscopy for the diagnosis of esophageal varices: a prospective three-center pilot study.

BACKGROUND AND STUDY AIMS: Variceal bleeding is a major complication of cirrhosis, and is associated with a 20 % mortality at 6 weeks. Current international guidelines recommend that patients with cirrhosis are screened by conventional upper endoscopy (esophagogastroduodenoscopy, EGD) in order to detect esophageal varices. The recently developed PillCam ESO esophageal capsule endoscope has been shown to be an accurate diagnostic tool in the investigation of patients with gastroesophageal reflux and Barrett's esophagus. We compared the PillCam ESO capsule endoscope with EGD for the detection of esophagogastric varices and portal hypertensive gastropathy in patients with cirrhosis. PATIENTS AND METHODS: A pilot trial was conducted at three sites. Patients with cirrhosis who were undergoing clinically indicated EGD for screening or surveillance for esophageal varices underwent a PillCam ESO study followed by an EGD within 48 hours. Capsule videos were assessed by an investigator who was blinded to the patient's medical history and EGD findings. RESULTS: A total of 23 of the 32 enrolled patients were found to have esophageal varices at both EGD and PillCam ESO endoscopy. In one patient PillCam ESO detected small varices that were not seen at EGD. The overall concordance between PillCam ESO and EGD was 96.9 % for the diagnosis of esophageal varices and 90.6 % for the diagnosis of portal hypertensive gastropathy. There were no adverse events related to PillCam ESO endoscopy. CONCLUSIONS: In a high-prevalence population, PillCam ESO may represent an accurate noninvasive alternative to EGD for the detection of esophageal varices and portal hypertensive gastropathy. A large-scale trial is underway to validate and expand these findings.

Sensitivity and specificity of the suspected blood identification system in video capsule enteroscopy.

BACKGROUND AND STUDY AIMS: Capsule enteroscopy has become a standard tool for the evaluation of obscure gastrointestinal bleeding. Reviewing the video recordings of capsule examinations is time-consuming and requires prolonged attention. Recently, software that can recognize the frames containing "red spots", the Suspected Blood Identification system (SBIS), has been developed with the aim of assisting in the analysis of video recordings. We assessed the sensitivity and specificity of the SBIS in patients undergoing capsule enteroscopy. PATIENTS AND METHODS: 100 consecutive patients underwent capsule enteroscopy at our tertiary referral center, for the following indications: obscure gastrointestinal bleeding (75 patients), metastatic carcinoid (7 patients) known or suspected Crohn's disease (5 patients), miscellaneous (13 patients). Capsule endoscopy was carried out by the standard method. Four gastroenterologists, experienced in capsule endoscopy, reviewed the recordings. RESULTS: Small-bowel visualization was obtained in 95 cases. The physicians identified 209 "red spots", 54 of which (25.8%) were also identified by the SBIS. The overall sensitivity, specificity, and positive and negative predictive values of the SBIS, calculated on the number of true-positive, true-negative, false-positive and false-negative results, were 40.9%, 70.7%, 69.2% and 42.6%, respectively. Sensitivity was higher for the identification of red blood (60.9%) than for nonbleeding "red" lesions such as arteriovenous malformations (25.8%). CONCLUSIONS: The SBIS has low sensitivity and specificity. It can be used as a complementary and rapid screening tool, but complete review of the recordings is still necessary.

Capsule enteroscopy in small bowel transplantation.

BACKGROUND: Enteroscopy plays a key role in the post-operative monitoring of patients with small bowel transplantation for the early detection of post-transplant complications and for the assessment of the graft's integrity. Routine surveillance enteroscopies (trans-stomal terminal ileoscopy or jejunoscopy) are invasive, may be unsafe in frail patients, and only allow incomplete exploration of the transplanted graft, which may be unsatisfactory. since the distribution of the lesions is often patchy or segmental. AIMS. To evaluate the potential of capsule enteroscopy, a new, minimally invasive technique which allows complete exploration of the small bowel. in small bowel transplant recipients. METHODS: Five small bowel transplanted patients underwent capsule enteroscopy with the GIVEN endoscopy system. The results of capsule enteroscopy were compared with those of trans-stomal ileoscopy. RESULTS: Capsule enteroscopy was better tolerated than ileoscopy and good quality images of the small bowel were obtained in four patients. The terminal ileum was normal both on ileoscopy and capsule enteroscopy. Mucosal changes in segments not reached by ileoscopy were detected by capsule enteroscopy in three of four patients. CONCLUSIONS: Capsule enteroscopy is better tolerated than ileoscopy, allows complete exploration of the transplanted graft and can detect mucosal changes in segments not reached by ileoscopy.

Unsuspected ileal stenosis causing obscure GI bleeding in patients with previous abdominal surgery--diagnosis by capsule endoscopy: a report of two cases.

Peri-anastomotic ulcerations may occur in patients with previous abdominal surgery. They may present only with obscure GI bleeding. We report two cases in whom capsule endoscopy identified postsurgical stenoses with ulcers as the cause of obscure GI bleeding. Case 1. A 57-year-old male operated on in 1970 for a post-traumatic diaphragm hernia followed by displacement of the caecum in the upper left abdominal quadrant. Case 2. A 32-year-old female with a salpingectomy for tuberculosis (1978) followed by segmental ileal resection for intestinal obstruction. Both patients had undergone extensive work-up including bidirectional endoscopies and enteroclysis with negative results. Capsule endoscopy with the GIVEN diagnostic system was done. Ileal stenoses with mucosal ulcers in dilated prestenotic loops were observed in both cases. The capsule was retained at the stenosis site, requiring ileal resection and anastomosis. Pathology reports showed mucosal ulcers. In case 2, tuberculosis was ruled out by tissue and faecal polymerase chain reaction and culture. Ileal stenoses with prestenotic ulcerations causing GI bleeding may occur in patients with previous abdominal surgery. Capsule endoscopy may clarify the diagnosis and shorten the diagnostic work-up. However, these patients should be warned that capsule retention requiring surgery might occur.

Review article: diagnosis, monitoring and treatment of distal colitis.

The diagnostic work-up of ulcerative colitis at presentation is based on the collection of clinical, microbiological, radiological, endoscopic and histologic data. Serological markers are characterized by too low a sensitivity to be commonly utilized in clinical practice. Although endoscopic and histologic features are characterized by very high sensitivity and specificity for the diagnosis of ulcerative colitis, negative stool cultures and parasites are mandatory to exclude an infectious aetiology at presentation. The treatment of choice of an acute flare-up of distal ulcerative colitis is represented by oral or topical mesalazine, or a combination of both, whereas the use of topical or systemic steroids should be restricted to patients who prove to be refractory to first-line treatments. Preliminary data suggest that the achievement of endoscopic and histologic remission after an acute flare of the disease might be associated with a prolonged remission.

Val34Leu factor XIII polymorphism in Italian patients with inflammatory bowel disease.

BACKGROUND: Coagulation Factor XIII is implicated in fibrin stabilization and wound healing. Plasma levels of Factor XIII are reduced in inflammatory bowel disease patients; recently, a valine 34 to leucine polymorphism of the Factor XIII-A subunit gene with a defined protective effect against thrombosis and as yet undetermined effect on wound healing has been described. AIM: To evaluate Val34Leu Factor XIII polymorphism distribution and to find possible correlations with clinical features in Italian inflammatory bowel disease patients. STUDY POPULATION: A total of 152 inflammatory bowel disease patients, 90 with ulcerative colitis and 62 with Crohn's disease and 130 healthy volunteers were studied. METHODS: Val34Leu polymorphism was detected by RFLP with BsaH I. Statistical analysis was performed by means of Fisher exact test. RESULTS: In inflammatory bowel disease, 57.2% of patients showed the wild type status, 37.5% were heterozygous and 5.3% were homozygous for the 34Leu allele; the frequency of the mutated allele was 24.0%. In controls, 66.1% of subjects showed the wild type status, 28.5% were heterozygous and 5.4% were homozygous for the 34Leu allele; the frequency of the mutated allele was 19.7%. There was no difference in genotype distribution and prevalence of the mutated allele between inflammatory bowel disease patients and controls. CONCLUSIONS: The present data do not show any differences in Val34Leu Factor XIII polymorphism distribution between inflammatory bowel disease patients and controls. The prothrombotic state described in inflammatory bowel disease patients does not depend on an altered distribution of Val34Leu Factor XIII polymorphism.