Maria Elena Riccioni

Capsule endoscopy versus colonoscopy for the detection of polyps and cancer.

BACKGROUND An ingestible capsule consisting of an endoscope equipped with a video camera at both ends was designed to explore the colon. This study compared capsule endoscopy with optical colonoscopy for the detection of colorectal polyps and cancer. METHODS We performed a prospective, multicenter study comparing capsule endoscopy with optical colonoscopy (the standard for comparison) in a cohort of patients with known or suspected colonic disease for the detection of colorectal polyps or cancer. Patients underwent an adapted colon preparation, and colon cleanliness was graded from poor to excellent. We computed the sensitivity and specificity of capsule endoscopy for polyps, advanced adenoma, and cancer. RESULTS A total of 328 patients (mean age, 58.6 years) were included in the study. The capsule was excreted within 10 hours after ingestion and before the end of the lifetime of the battery in 92.8% of the patients. The sensitivity and specificity of capsule endoscopy for detecting polyps that were 6 mm in size or bigger were 64% (95% confidence interval [CI], 59 to 72) and 84% (95% CI, 81 to 87), respectively, and for detecting advanced adenoma, the sensitivity and specificity were 73% (95% CI, 61 to 83) and 79% (95% CI, 77 to 81), respectively. Of 19 cancers detected by colonoscopy, 14 were detected by capsule endoscopy (sensitivity, 74%; 95% CI, 52 to 88). For all lesions, the sensitivity of capsule endoscopy was higher in patients with good or excellent colon cleanliness than in those with fair or poor colon cleanliness. Mild-to-moderate adverse events were reported in 26 patients (7.9%) and were mostly related to the colon preparation. CONCLUSIONS The use of capsule endoscopy of the colon allows visualization of the colonic mucosa in most patients, but its sensitivity for detecting colonic lesions is low as compared with the use of optical colonoscopy. (ClinicalTrials.gov number, NCT00604162.)

European Society of Gastrointestinal Endoscopy (ESGE): recommendations (2009) on clinical use of video capsule endoscopy to investigate small-bowel, esophageal and colonic diseases.

These recommendations on video capsule endoscopy, an emerging technology with an impact on the practice of endoscopy, were developed by the European Society of Gastrointestinal Endoscopy (ESGE) Guidelines Committee. The first draft of each section was prepared by one or two members of the writing team, who were selected as experts on the content of that section on the basis of their published work. They used evidence-based methodology, performing MEDLINE and PubMed literature searches to identify relevant clinical studies. Abstracts from scientific meetings were included only if there was no published full paper on a particular topic. If there was disagreement, the first author of the Guideline made the final decision. Recommendations were graded according to the strength of the supporting evidence. The draft guideline was critically reviewed by all authors and submitted to the ESGE councillors for their critical review before approval of the final document. The ESGE Guidelines Committee acknowledges that this document is based on a critical review of the data available at the time of preparation and that further studies may be needed to clarify some aspects. Moreover, this Guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. This document should be regarded as supplying recommendations only to gastroenterologists in providing care to their patients. It is not a set of rules and should not be construed as establishing a legal standard of care, or as encouraging, advocating, requiring, or discouraging any particular treatment. These recommendations must be interpreted according to the clinicians knowledge, expertise, and clinical judgment in the management of individual patients and, if necessary, a course of action that varies from recommendations must be undertaken.

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.

Second-generation colon capsule endoscopy compared with colonoscopy

BACKGROUND Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system. OBJECTIVE To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy. DESIGN AND SETTING Prospective, multicenter trial including 8 European sites. PATIENTS This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed. INTERVENTION CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day. MAIN OUTCOME MEASUREMENTS CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopy-negative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed. RESULTS Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients. LIMITATIONS Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients. CONCLUSION In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging.

Video capsule enteroscopy in the diagnosis of celiac disease : a multicenter study

OBJECTIVES:Duodenal biopsy is the current gold standard for diagnosis of celiac disease. Videocapsule endoscopy examines the entire small bowel and allows visualization of mucosal villi. We evaluated the potential of videocapsule endoscopy in assessing the severity and extent of mucosal changes in patients with suspected celiac disease.METHODS:Consecutive patients with signs/symptoms suggesting celiac disease and positive anti-gliadin and/or anti-endomysial and/or anti-tissue transglutaminase antibodies underwent upper gastrointestinal endoscopy and videocapsule endoscopy. Duodenal biopsies were classified according to modified Marshs criteria. Capsule findings were evaluated for the presence of lesions compatible with celiac disease (scalloping of duodenal folds, fissures, flat mucosa, and mosaic appearance).RESULTS:Forty-three patients were studied. Duodenal histology was normal in 11 and compatible with celiac disease in 32. Using duodenal histology as the gold standard, the performance characteristics of capsule endoscopy for the diagnosis of celiac disease were: sensitivity 87.5% (95% CI 76.1–98.9%), specificity 90.9% (95% CI 81.0–100%), positive predictive value 96.5% (95% CI 90.1–100%), negative predictive value 71.4% (95% CI 55.8–87%), positive and negative likelihood ratios 9.6 and 0.14, respectively. Eighteen patients had mucosal changes extending beyond the duodenum, involving the entire small bowel in three. These patients tended to have more severe symptoms, but the difference was not statistically significant. Interobserver agreement for the diagnosis of celiac disease by capsule endoscopy ranged between 79.2 and 94.4%; kappa values ranged between 0.56 and 0.87.CONCLUSIONS:Videocapsule endoscopy shows good sensitivity and excellent specificity for the detection of villous atrophy in patients with suspected celiac disease.

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.

Prospective evaluation of a new self-expanding plastic stent for inoperable esophageal strictures

BACKGROUND High stent cost is considered the major drawback of self-expanding metal stents for dysphagia palliation in patients with inoperable esophageal strictures. We report our experience with a self-expanding plastic (Polyflex) stent, the cost of which is half that of the metal stents. METHODS Between September 1999 and April 2001, 16 dysphagic patients (15 men; mean age, 69.4 +/- 14.5 years; range, 49-100 years; mean dysphagia score, 3.31 +/- 0.6) with esophageal strictures who underwent Polyflex stent placement (insertion device diameter, 12-14 mm; postexpansion inner stent diameter, 16-21 mm; stent length, 9, 12, and 15 cm) were studied prospectively. The strictures were caused by postsurgical recurrence of gastric/esophageal cancer at the anastomotic site in five patients, primary esophageal cancer in four patients, esophagocardia junction cancer in four patients, metastatic mediastinal lymph nodes from a primary lung cancer invading the esophagus in 1 patient, and benign peptic stricture in two elderly patients. All the patients were prospectively followed until death. RESULTS Stent insertion was technically successful in 12 patients (75%). Stent placement failed in four patients (25%) because of failure to pass the delivery catheter across the stricture in three patients and failure of the stent to open in one patient. Early and late stent migration occurred in two patients and 1 patient, respectively. Tumor overgrowth occurred in 1 patient. The mean dysphagia score 7 days after stent placement was 1.1 +/- 0.9. Mean survival was 100.6 +/- 71.2 days (range, 8-225 days). CONCLUSION Self-expanding Polyflex stents are safe and effective for inoperable esophageal strictures and have an acceptable technical success rate. Further experience, better selection criteria, and design improvements should improve results.

Video capsule endoscopy in patients with known or suspected small bowel stricture previously tested with the dissolving patency capsule

Goals To assess the safety of the Pillcam in patients with known or suspected radiologic stricture, previously tested for small bowel patency using the Given Patency capsule. Background Intestinal stricture contributes a major contraindication to video capsule endoscopy (VCE), because of the risk of capsule retention. Study Twenty-seven patients (16 female, mean age 44.2 y) with known or suspected intestinal stricture were enrolled prospectively. Twenty-four had Crohns disease, 2 had adhesive syndrome and 1 had a suspected ischemic stricture. Patients underwent the Patency capsule test. In patients in whom the Patency capsule was excreted intact within 72 hours postingestion without occurrence of any adverse event, VCE was performed to assess the presence of strictures or other gastrointestinal pathologies. The following parameters were evaluated: transit time of Patency capsules and/or tags from ingestion to excretion, condition of the Patency capsule at excretion, transit time of the Pillcam capsule, the ability of Pillcam capsule to detect intestinal strictures and small bowel pathologies, any adverse events. Results Twenty-five patients (92.6%) retrieved the Patency capsule in the stools. Six patients complained of abdominal pain, 4 of whom excreted a nonintact capsule. Hospitalization was required in 1 (4.3%) patient with Crohns disease due to occlusive syndrome. Fifteen patients (65.3%) excreted an intact Patency capsule after a mean transit time of 25.6 hours without any adverse events. These 15 patients underwent the VCE successfully. Conclusions Passage of an intact Patency capsule across a small bowel stricture provides direct evidence of functional patency of the gut lumen and allows a safe VCE. Intestinal strictures should not be considered an absolute contraindication for VCE.

PillCam colon capsule endoscopy: a prospective, randomized trial comparing two regimens of preparation.

Goal Aim of this study is to assess the feasibility of substituting sodium phosphate (NaP) with polyethylene glycol (PEG)-boosters in the protocol preparation for PillCam Colon Capsule Endoscopy (CCE). Background CCE represents a new diagnostic, endoscopic technology for colonic exploration. Bowel preparation for CCE is necessary not only to clean the colon, but also to promote capsule propulsion. For this reason, NaP boosters have been added to a 4 L PEG-preparation. NaP has been recently related with major side-effects. Study Forty patients were prospectively randomized to Standard (n=20) or Modified (n=20) regimen. Standard regimen included clear liquid diet, 4 L of PEG, and 1 or 2 NaP boosters. In the Modified regimen, NaP boosters were substituted by 1 or 2 PEG boosters; 4 senna tablets and a low-residue diet were also included. Patients underwent CCE and conventional colonoscopy, carried out on the same day. CCE excretion rate, colon transit time, colon cleansing, and accuracy were evaluated. Results Hundred percent and 75% of CCE were excreted with the Standard and Modified regimen, respectively (P=0.02). Mean±SE colonic transit time of capsule was 2.17±1.43 hours in the Standard group, and 5.32±2.53 hours in the Modified group (P<0.001). Adequate preparation was achieved in 42.5% of the cases, without statistically significant difference between the 2 groups (35% vs. 53%; P=NS). CCE sensitivity and specificity for ≥6 mm polyps were 63% and 87%, without difference between the 2 groups. Conclusions The exclusion of NaP booster from CCE preparation resulted into a clinically meaningful reduction of the capsule excretion rate that was only partially compensated by the PEG booster.

Analysis of complications of endoscopic sphincterotomy for biliary stones in a consecutive series of 546 patients.

AbstractBackground: Endoscopic sphincterotomy (ES) plays an important role in treatment of biliary stones; however, there remain some controversies concerning complications of ES, which in most cases seem not to be predictable. Methods: The aim of this study was a retrospective analysis of complications in 546 consecutive patients (267 males, 279 females, average age 63.7 years) who underwent endoscopic retrograde cholangiography (ERCP) for biliary stones from 1988 to 1995. Results: ES was performed in 535 patients (98%), and extraction of stones was successful in 493 (92%). In all, 29 complications (5.4%) were observed, including bleeding 13, cholangitis seven, cholecystitis four, pancreatitis three, retroduodenal perforation two; of these, four (14%) required an operation. Overall mortality was 0.3%. Conclusion: While a significant decrease of the incidence of complications was observed in the course of the study, due to constantly improving experience, no correlation between risk factors and complications was identified.