Paola Cesaro

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.

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.

Colon capsule versus CT colonography in patients with incomplete colonoscopy: a prospective, comparative trial

Objective In case of incomplete colonoscopy, several radiologic methods have traditionally been used, but more recently, capsule endoscopy was also shown to be accurate. Aim of this study was to compare colon capsule endoscopy (CCE) and CT colonography (CTC) in a prospective cohort of patients with incomplete colonoscopy. Design Consecutive patients with a previous incomplete colonoscopy underwent CCE and CTC followed by colonoscopy in case of positive findings on either test (polyps/mass lesions ≥6 mm). Clinical follow-up was performed in the other cases to rule out missed cancer. CTC was performed after colon capsule excretion or 10–12 h postingestion. Since the gold standard colonoscopy was performed only in positive cases, diagnostic yield and positive predictive values of CCE and CTC were used as study end-points. Results 100 patients were enrolled. CCE and CTC were able to achieve complete colonic evaluation in 98% of cases. In a per-patient analysis for polyps ≥6 mm, CCE detected 24 patients (24.5%) and CTC 12 patients (12.2%). The relative sensitivity of CCE compared to CTC was 2.0 (95% CI 1.34 to 2.98), indicating a significant increase in sensitivity for lesions ≥6 mm. Of larger polyps (≥10 mm), these values were 5.1% for CCE and 3.1% for CTC (relative sensitivity: 1.67 (95% CI 0.69 to 4.00)). Positive predictive values for polyps ≥6 mm and ≥10 mm were 96% and 85.7%, and 83.3% and 100% for CCE and CTC, respectively. No missed cancer occurred at clinical follow-up of a mean of 20 months. Conclusions CCE and CTC were of comparable efficacy in completing colon evaluation after incomplete colonoscopy; the overall diagnostic yield of colon capsule was superior to CTC. Trial registration number NCT01525940.

Validation of the diagnostic accuracy of probe-based confocal laser endomicroscopy for the characterization of indeterminate biliary strictures: results of a prospective multicenter international study

BACKGROUND Characterization of indeterminate biliary strictures remains problematic. Tissue sampling is the criterion standard for confirming malignancy but has low sensitivity. Probe-based confocal laser endomicroscopy (pCLE) showed excellent sensitivity in a registry; however, it has not been validated in a prospective study. OBJECTIVE To prospectively validate pCLE in real time during ERCP for indeterminate biliary strictures. DESIGN Prospective, international, multicenter study. SETTING Six academic centers. PATIENTS A total of 136 patients with indeterminate biliary strictures. INTERVENTIONS Investigators provided a presumptive diagnosis based on the patient history, ERCP impression, and pCLE during the procedure before and after tissue sampling results were available. A presumptive diagnosis also was made separately by a blinded investigator during ERCP and after tissue sampling to estimate care without pCLE. Follow-up was at least 6 months. MAIN OUTCOME MEASUREMENTS Accuracy, sensitivity, and specificity during ERCP alone, ERCP with pCLE, and ERCP with pCLE and tissue sampling. RESULTS A total of 112 patients were evaluated (71 with malignant lesions). Tissue sampling alone was 56% sensitive, 100% specific, and 72% (95% confidence interval [CI], 63%-80%) accurate. pCLE with ERCP was 89% sensitive, 71% specific, and 82% (95% CI, 74%-89%) accurate. After tissue sampling returned, strictures could be characterized with 88% (95% CI, 81%-94%) accuracy. LIMITATIONS No randomization of care maps. pCLE not blinded. CONCLUSION pCLE provided a more accurate and sensitive diagnosis of cholangiocarcinoma compared with tissue sampling alone. Incorporation of pCLE into the diagnostic armamentarium of patients with indeterminate biliary strictures may allow for a more accurate assessment, potentially reducing delays in diagnosis and costly repeat testing. ( CLINICAL TRIAL REGISTRATION NUMBER NCT01392274.).

High accuracy and cost-effectiveness of a biopsy-avoiding endoscopic approach in diagnosing coeliac disease

The ‘immersion’ technique during upper endoscopy allows the visualization of duodenal villi and the detection of total villous atrophy.

A new regimen of bowel preparation for PillCam colon capsule endoscopy: a pilot study.

BACKGROUND Colon capsule endoscopy (CCE) represents a new diagnostic, endoscopic technology for colonic exploration. Current protocols of preparation led to discordant rates of adequate cleansing level or CCE excretion. AIM To evaluate the effect of a new regimen of bowel preparation for CCE on colon cleansing levels and on rate of capsule excretion. STUDY 60 patients were prospectively enrolled. The new regimen of preparation consisted of a split regimen of PEG administration and of a 45 mL dose of sodium phosphate (NaP). Four senna tablets and a low-residue diet were also included. CCE excretion rate, colon cleansing, and accuracy were assessed. RESULTS Forty-six patients were included in the final analysis, 13 patients (22%) being excluded because of preparation protocol deviations and one due to CCE technical failure (2%). At CCE, bowel preparation was rated as good in 78% of patients, fair in 20% and poor in 2%. CCE excretion rate occurred in 83% of patients. CCE sensitivity and specificity for significant findings was 100% and 95%, respectively. CONCLUSIONS The combination of a split-dose of PEG solution with a low dose of NaP boosters resulted in high rates of adequate cleansing level and CCE excretion.

Accuracy and safety of second-generation PillCam COLON capsule for colorectal polyp detection:

PillCam COLON capsule endoscopy (CCE) (Given Imaging Ltd, Yoqneam, Israel) is one of the most recent diagnostic, endoscopic technologies designed to explore the colon. CCE is a noninvasive, patient-friendly technique that is able to explore the colon without requiring sedation and air insufflation. The first generation of CCE was released onto the market in 2006 and although it generated great enthusiasm, it showed suboptimal accuracy. Recently, a second-generation system (PillCam COLON 2) (CCE-2) has been developed to increase sensitivity for colorectal polyp detection. In this review, accuracy and safety data for CCE-2 are analyzed.

Role of the immersion technique in diagnosing celiac disease with villous atrophy limited to the duodenal bulb

Goals To investigate if the so-called immersion technique during upper endoscopy may be helpful to predict patterns of villous atrophy restricted to the duodenal bulb. Background Patients with celiac disease may have a patchy distribution of duodenal villous atrophy. In some cases, mucosa of duodenal bulb may be the only intestinal area involved. The immersion technique is a novel procedure that allows visualizing duodenal villi directly during endoscopy. Study With this prospective study, the immersion duodenoscopy was performed in 67 celiac subjects to investigate their duodenal villous pattern. Villi were evaluated both in the first and in the second duodenal segment and judged as present or absent (flat mucosa). Results were compared with histology as reference. Results Among celiac subjects, 49 were newly diagnosed and 18 previously diagnosed celiac patients. Four (8%) newly diagnosed and 7 (39%) previously diagnosed celiac subjects had an extension of the villous atrophy (flat mucosa) limited to the duodenal bulb. The sensitivity, specificity, and positive and negative predictive values of the immersion-based duodenal investigation in predicting areas of duodenal villous atrophy was always 100%. Conclusions Immersion technique may be useful for directing duodenal biopsies in celiac subjects with a patchy distribution of villous atrophy. This procedure can avoid blinded sampling of the duodenal mucosa and enhance the diagnostic yield.

The water immersion technique is easy to learn for routine use during EGD for duodenal villous evaluation: a single-center 2-year experience.

Goals We investigated the learning parameters of the immersion technique for the assessment of marked villous atrophy (MVA), during routine esophagogastroduodenoscopy (EGD). Background The immersion technique offers a proven possibility of enhancing the sensitivity of endoscopy in detecting duodenal villous atrophy patterns. Study Nine endoscopists with at least 2 years of experience, who had previously been trained to perform the immersion technique, searched for duodenal villi during routine EGD. In a 2-year study, duodenal villi were evaluated underwater duodenoscopy in 432 patients from whom duodenal biopsies had been, for various reasons, obtained. The endoscopic findings were compared with the histology. The learning parameters of the water immersion technique and the accuracy in detecting subjects with MVA were observed. Results A total of 28 (6.5%) patients with MVA were identified during endoscopy by the trained endoscopists. All these patients were diagnosed as being celiac patients. The sensitivity, specificity, and accuracy (positive and negative predictive values) of the immersion technique in detecting MVA patterns, irrespective of the endoscopist who performed the examination, were always 100%. Conclusions The underwater evaluation of the duodenum can be efficiently and regularly performed during routine EGD by endoscopists with 2 years of experience, after a specific, brief training period. This procedure is simple, feasible, and can accurately detect MVA patterns.

A new low-volume isosmotic polyethylene glycol solution plus bisacodyl versus split-dose 4 L polyethylene glycol for bowel cleansing prior to colonoscopy: a randomised controlled trial.

BACKGROUND 4-L polyethylene glycol preparations are effective for colon cleansing before colonoscopy. However, large volume and unpleasant taste reduce tolerability and acceptability limiting patient compliance. A new isosmotic low-volume polyethylene glycol preparation with citrates and simethicone plus bisacodyl has been developed to improve patient compliance and tolerability. AIM To compare the efficacy of 2 different regimens of preparation vs a split-dose of polyethylene glycol solution. PATIENTS AND METHODS In this randomised, blinded, comparative study, 153 patients were allocated to 3 arms. Arm 1 (n=52) received bisacodyl and 2-L polyethylene glycol with citrates and simethicone the day before the procedure. Arm 2 (n=50) received bisacodyl the day before and 2-L polyethylene glycol with citrates and simethicone on the day of colonoscopy. Control group (n=51) received a split-dose of 4-L polyethylene glycol. Cleansing was evaluated according to Ottawa scale. RESULTS The mean Ottawa score was not different in the 3 groups. Excellent cleansing was observed more frequently in arm 2 (70%) than in controls (49%) (p<0.05). No serious adverse events were observed in the 3 regimens. The willingness to repeat the same bowel preparation was superior in arms 1 and 2 than in controls (p<0.001). CONCLUSIONS New low-volume preparations seem to be as effective as the split 4-L polyethylene glycol regimen, showing a better tolerability and acceptability.