Guido Costamagna

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 experts consensus statement on cystic tumours of the pancreas.

Cystic lesions of the pancreas are increasingly recognized. While some lesions show benign behaviour (serous cystic neoplasm), others have an unequivocal malignant potential (mucinous cystic neoplasm, branch- and main duct intraductal papillary mucinous neoplasm and solid pseudo-papillary neoplasm). European expert pancreatologists provide updated recommendations: diagnostic computerized tomography and/or magnetic resonance imaging are indicated in all patients with cystic lesion of the pancreas. Endoscopic ultrasound with cyst fluid analysis may be used but there is no evidence to suggest this as a routine diagnostic method. The role of pancreatoscopy remains to be established. Resection should be considered in all symptomatic lesions, in mucinous cystic neoplasm, main duct intraductal papillary mucinous neoplasm and solid pseudo-papillary neoplasm as well as in branch duct intraductal papillary mucinous neoplasm with mural nodules, dilated main pancreatic duct >6mm and possibly if rapidly increasing in size. An oncological partial resection should be performed in main duct intraductal papillary mucinous neoplasm and in lesions with a suspicion of malignancy, otherwise organ preserving procedures may be considered. Frozen section of the transection margin in intraductal papillary mucinous neoplasm is suggested. Follow up after resection is recommended for intraductal papillary mucinous neoplasm, solid pseudo-papillary neoplasm and invasive cancer.

Biliary stenting: indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline.

This article is part of a combined publication that expresses the current view of the European Society of Gastrointestinal Endoscopy about endoscopic biliary stenting. The present Clinical Guideline describes short-term and long-term results of biliary stenting depending on indications and stent models; it makes recommendations on when, how, and with which stent to perform biliary drainage in most common clinical settings, including in patients with a potentially resectable malignant biliary obstruction and in those who require palliative drainage of common bile duct or hilar strictures. Treatment of benign conditions (strictures related to chronic pancreatitis, liver transplantation, or cholecystectomy, and leaks and failed biliary stone extraction) and management of complications (including stent revision) are also discussed. A two-page executive summary of evidence statements and recommendations is provided. A separate Technology Review describes the models of biliary stents available and the stenting techniques, including advanced techniques such as insertion of multiple plastic stents, drainage of hilar strictures, retrieval of migrated stents and combined stenting in malignant biliary and duodenal obstructions.The target readership for the Clinical Guideline mostly includes digestive endoscopists, gastroenterologists, oncologists, radiologists, internists, and surgeons while the Technology Review should be most useful to endoscopists who perform biliary drainage.

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.

Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study

BACKGROUND EUS-guided FNA is an efficacious technique for sampling intraintestinal and extraintestinal mass lesions. However, cytology has limitations to its final yield and accuracy, which may be overcome if histological specimens are provided to the pathologist. OBJECTIVE To evaluate feasibility, yield, and diagnostic accuracy of a newly developed 19-gauge, fine-needle biopsy (FNB) device. DESIGN Multicenter, pooled, cohort study. SETTING Five medical centers. PATIENTS This study involved 109 consecutive patients with 114 intraintestinal or extraintestinal mass lesions and/or peri-intestinal lymph nodes. INTERVENTION EUS-guided FNB (EUS-FNB) with a newly developed, 19-gauge, FNB device. MAIN OUTCOME MEASUREMENTS Percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation and the overall diagnostic accuracy compared with a composite criterion-standard diagnosis. RESULTS We evaluated 114 lesions (mean [± standard deviation] size 35.1 ± 18.7 mm; 84 malignant [73.7%] and 30 [26.3%] benign). EUS-FNB was technically feasible in 112 lesions (98.24%). Sample quality was adequate for full histological assessment in 102 lesions (89.47%). In 98 cases (85.96%), diagnosis proved to be correct according to criterion-standard diagnosis. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy for diagnosis of malignancy were 90.2%, 100%, 100%, 78.9%, and 92.9%, respectively. LIMITATIONS Use of a surrogate criterion-standard diagnosis, including clinical follow-up when no surgical specimens were available, mainly in benign diagnoses. CONCLUSION Performing an EUS-FNB with a new 19-gauge histology needle is feasible for histopathology diagnosis of intraintestinal and extraintestinal mass lesions, offering the possibility of obtaining a core sample for histological evaluation in the majority of cases, with an overall diagnostic accuracy of over 85%.

Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection

Faecal microbiota transplantation (FMT) from healthy donors is considered an effective treatment against recurrent Clostridium difficile infection.

Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos)

BACKGROUND The feasibility of single-operator cholangioscopy (SOC) for biliary diagnostic and therapeutic procedures was previously reported. OBJECTIVE To confirm the utility of SOC in more widespread clinical use. DESIGN Prospective clinical cohort study. SETTING Fifteen endoscopy referral centers in the United States and Europe. PATIENTS Two hundred ninety-seven patients requiring evaluation of bile duct disease or biliary stone therapy. INTERVENTIONS SOC examination and, as indicated, SOC-directed stone therapy or forceps biopsy. MAIN OUTCOME MEASUREMENTS Procedural success defined as ability to (1) visualize target lesions and, if indicated, collect biopsy specimens adequate for histological evaluation or (2) visualize biliary stones and initiate fragmentation and removal. RESULTS The overall procedure success rate was 89% (95% CI, 84%-92%). Adequate tissue for histological examination was secured in 88% of 140 patients who underwent biopsy. Overall sensitivity in diagnosing malignancy was 78% for SOC visual impression and 49% for SOC-directed biopsy. Sensitivity was higher (84% and 66%, respectively) for intrinsic bile duct malignancies. Diagnostic SOC procedures altered clinical management in 64% of patients. Procedure success was achieved in 92% of 66 patients with stones and complete stone clearance during the study SOC session in 71%. The incidence of serious procedure-related adverse events was 7.5% for diagnostic SOC and 6.1% for SOC-directed stone therapy. LIMITATIONS The study was observational in design with no control group. CONCLUSIONS Evaluation of bile duct disease and biliary stone therapy can be safely performed with a high success rate by using the SOC system.

Treatment for painful calcified chronic pancreatitis: extracorporeal shock wave lithotripsy versus endoscopic treatment: a randomised controlled trial

Background: In chronic pancreatitis, obstruction of the main pancreatic duct (MPD) may contribute to the pathogenesis of pain. Pilot studies suggest that extracorporeal shock wave lithotripsy (ESWL) alone relieves pain in calcified chronic pancreatitis. Aim: To compare ESWL alone with ESWL and endoscopic drainage of the MPD for treatment of pain in chronic pancreatitis. Subjects: Patients with uncomplicated painful chronic pancreatitis and calcifications obstructing the MPD. Methods: 55 patients were randomised to ESWL alone (n = 26) or ESWL combined with endoscopy (n = 29). Results: 2 years after trial intervention, 10 (38%) and 13 (45%) patients of the ESWL alone and ESWL combined with endoscopy group, respectively, had presented pain relapse (primary outcome) (OR 0.77; 95% CI 0.23 to 2.57). In both groups, a similar decrease was seen after treatment in the MPD diameter (mean decrease 1.7 mm; 95% CI 0.9 to 2.6; p<0.001), and in the number of pain episodes/year (mean decrease, 3.7; 95% CI 2.6 to 4.9; p<0.001). Treatment costs per patient were three times higher in the ESWL combined with endoscopy group compared with the ESWL alone group (p = 0.001). The median delay between the onset of chronic pancreatitis and persistent pain relief for both groups was 1.1 year (95% CI 0.7 to 1.6), as compared with 4 years (95% CI 3 to 4) for the natural history of chronic pancreatitis in a reference cohort (p<0.001). Conclusions: ESWL is a safe and effective preferred treatment for selected patients with painful calcified chronic pancreatitis. Combining systematic endoscopy with ESWL adds to the cost of patient care, without improving the outcome of pancreatic pain.

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.

Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline

BACKGROUND AND AIMS Clarification of the position of the European Society of Gastrointestinal Endoscopy (ESGE) regarding the interventional options available for treating patients with chronic pancreatitis. METHODS Systematic literature search to answer explicit key questions with levels of evidence serving to determine recommendation grades. The ESGE funded development of the Guideline. SUMMARY OF SELECTED RECOMMENDATIONS For treating painful uncomplicated chronic pancreatitis, the ESGE recommends extracorporeal shockwave lithotripsy/endoscopic retrograde cholangiopancreatography as the first-line interventional option. The clinical response should be evaluated at 6 - 8 weeks; if it appears unsatisfactory, the patients case should be discussed again in a multidisciplinary team. Surgical options should be considered, in particular in patients with a predicted poor outcome following endoscopic therapy (Recommendation grade B). For treating chronic pancreatitis associated with radiopaque stones ≥ 5 mm that obstruct the main pancreatic duct, the ESGE recommends extracorporeal shockwave lithotripsy as a first step, combined or not with endoscopic extraction of stone fragments depending on the expertise of the center (Recommendation grade B). For treating chronic pancreatitis associated with a dominant stricture of the main pancreatic duct, the ESGE recommends inserting a single 10-Fr plastic stent, with stent exchange planned within 1 year (Recommendation grade C). In patients with ductal strictures persisting after 12 months of single plastic stenting, the ESGE recommends that available options (e. g., endoscopic placement of multiple pancreatic stents, surgery) be discussed in a multidisciplinary team (Recommendation grade D).For treating uncomplicated chronic pancreatic pseudocysts that are within endoscopic reach, the ESGE recommends endoscopic drainage as a first-line therapy (Recommendation grade A).For treating chronic pancreatitis-related biliary strictures, the choice between endoscopic and surgical therapy should rely on local expertise, patient co-morbidities and expected patient compliance with repeat endoscopic procedures (Recommendation grade D). If endoscopy is elected, the ESGE recommends temporary placement of multiple, side-by-side, plastic biliary stents (Recommendation grade A).