Peter J. van der Schaar

A novel ingestible electronic drug delivery and monitoring device

BACKGROUNDnWe developed an ingestible electronic drug delivery and monitoring system. This system includes an electronic capsule comprising a drug reservoir, a pH and temperature sensor, a microprocessor and wireless transceiver, a stepper motor, and batteries. The location of the capsule in the gut derived from pH data can be monitored in real time. The stepper motor can be remotely actuated to expel the contents of the drug reservoir.nnnOBJECTIVESnFirst human study.nnnDESIGNnTwo consecutive observational studies.nnnSETTINGnUniversity medical center.nnnSUBJECTSnTwenty healthy volunteers.nnnINTERVENTIONSnStudy I: Ingestion and passage of the capsule. Study II: Ingestion and passage of the capsule, loaded with (99m)technetium-pertechnetate ((99m)Tc); remotely actuated expulsion of (99m)Tc in the gut.nnnMAIN OUTCOME MEASUREMENTSnStudy I: Safety, tolerability, and functionality (wireless pH and temperature recording). Study II: Tracing of the capsule and expulsion and distribution of (99m)Tc from the drug reservoir by scintigraphy. Correlating location pH with scintigraphy.nnnRESULTSnStudy I: Ingestion and passage of the capsule was safe and well tolerated. Transmitted pH and temperature data were received by the recorder in 96.5% ± 3%. Study II: pH-determined passage of the esophagogastric, gastroduodenal, and ileocolonic junction correlated well with scintigraphy. Expulsion of (99m)Tc from the capsule was successful in 9 of 10 subjects.nnnLIMITATIONSnSubjects with relatively low body mass index.nnnCONCLUSIONSnThis electronic drug delivery and monitoring system may be a promising tool for targeted delivery of substances to well-defined areas of the GI tract.

Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score

BACKGROUNDnAdequate bowel preparation is important for optimal colonoscopy. It is important to identify patients at risk for inadequate bowel preparation because this allows taking precautions in this specific group.nnnOBJECTIVEnTo develop a prediction score to identify patients at risk for inadequate bowel preparation who may benefit from an intensified bowel cleansing regimen.nnnDESIGNnPatient and colonoscopy data were prospectively collected, whereas clinical data were retrospectively collected for a total of 1996 colonoscopies in participants who received split-dose bowel preparation. Multivariate logistic regression analyses were conducted in a random two-thirds of the cohort to develop a prediction model.xa0Validation and evaluation of the discriminative power of the prediction model were performed within the remaining one-third of the cohort.nnnSETTINGnFour centers, including one academic and three medium-to-large size nonacademic centers.nnnPATIENTSnConsecutive colonoscopies in November and Decemberxa02012. Mean age was 57.3 ± 15.9 years, 45.8% were male and indications for colonoscopy were screening and/or surveillance (27%), abdominal symptoms and/or blood loss and/or anemia (60%), inflammatory bowel disease (9%), and others (4%).nnnINTERVENTIONSnColonoscopy.nnnMAIN OUTCOME MEASUREMENTSnInadequate bowel preparation defined as Boston Bowel Preparation Scale scorexa0<6.nnnRESULTSnA total of 1331 colonoscopies were included in the development cohort, of which 172 (12.9%) had anxa0inadequate bowel preparation. Independent factors included in the prediction model were American Society of Anesthesiologists Physical Status Classification System scorexa0≥3, use of tricyclic antidepressants, use of opioids, diabetes, chronic constipation, history of abdominal and/or pelvic surgery, history of inadequate bowel preparation, and current hospitalization. The discriminative ability of the scale was good, with an area under the curve of 0.77 in the validation cohort.nnnLIMITATIONSnStudy design partially retrospective, no data on patient compliance.nnnCONCLUSIONnWe developed a validated, easy-to-use prediction scale that can be used to identify subjects with an increased risk of inadequate bowel preparation with good accuracy.

No beneficial effects of amantadine in treatment of chronic hepatitis C patients.

BACKGROUNDnBenefit of adding amantadine to antiviral therapy for hepatitis C is controversial.nnnAIMSnWe aimed to examine whether such policy enhances sustained viral response in treatment-naïve patients.nnnMETHODSn297 naïve hepatitis C patients were randomized for treatment with amantadine 200mg or placebo, combined with weight-based ribavirin and 12-day high-dose interferon alpha-2b induction therapy, followed by PEG-interferon alpha-2b (1.5 microg/kg/week up to 26 weeks and thereafter, 1.0 microg/kg/week until week 52). Treatment was discontinued if hepatitis C virus (HCV) RNA was positive at week 24.nnnRESULTSn49% of patients were (former) drug users. Genotype 1 occurred in 45%, high viral load in 70% and severe fibrosis/cirrhosis in 32%, without differences between amantadine or placebo groups. 90 patients prematurely discontinued treatment, mainly because of grade 3 or 4 toxicity. Intention-to-treat analysis revealed sustained viral response in 47% and 51% of amantadine and placebo groups (p=0.49). Amantadine did not enhance sustained viral response in patients with genotype 1 or high viral load nor did it improve primary non-response, breakthrough or relapse rates. Genotype non-1 and lower pre-treatment gamma GT levels were independent predictors for sustained viral response.nnnCONCLUSIONnAdding amantadine to antiviral therapy of previously untreated chronic hepatitis C patients has no beneficial effects.

Comparison of cecal intubation and adenoma detection between hospitals can provide incentives to improve quality of colonoscopy

BACKGROUND AND STUDY AIMSnCecal intubation rate (CIR) and adenoma detection rate (ADR) have been found to be inversely associated with the occurrence of post-colonoscopy colorectal cancer. Depicting differences in CIR and ADR between hospitals could provide incentives for quality improvement. The aim of this study was to compare quality parameters of routine colonoscopies between seven hospitals in The Netherlands in order to determine the extent to which possible differences were attributable to procedural and institutional factors.nnnPATIENTS AND METHODSnConsecutive patients undergoing colonoscopy were prospectively included between November 2012 and January 2013u200aat two academic and five nonacademic hospitals. Patients with inflammatory bowel disease or hereditary colorectal cancer syndromes were excluded. Main outcome measures were CIR and ADR.nnnRESULTSnA total of 3129 patients were included (mean age 59u200a±u200a15 years; 45.5u200a% male). The majority of patients (86.2u200a%) had a Boston Bowel Preparation Scale (BBPS) score ≥xa06. Overall CIR was 94.8u200a%, ranging from 89.4u200a% to 99.2u200a% between hospitals. After adjustment for case mix (age, sex, American Society of Anesthesiologists score, and indication for colonoscopy), factors associated with CIR were hospital and a BBPS score ≥xa06.u200aOverall ADR was 31.8u200a% and varied between hospitals, ranging from 24.8u200a% to 46.8u200a%. Independent predictors for ADR were hospital, BBPS score ≥xa06, and cecal intubation. By combining CIR and ADR for each hospital, a colonoscopy quality indicator (CQI) was developed, which can be used by hospitals to stimulate quality improvement.nnnCONCLUSIONnDifferences in the quality of colonoscopy between hospitals can be demonstrated using CIR and ADR. As both indicators are affected by institution and bowel preparation, a comparison between hospitals based on the newly developed CQI could assist in further improving the quality of colonoscopy.

Electromagnetic-guided placement of nasoduodenal feeding tubes versus endoscopic placement: a randomized, multicenter trial

BACKGROUND AND AIMSnElectromagnetic-guided placement (EMP) of a nasoduodenal feeding tube by trained nurses is an attractive alternative to EGD-guided placement (EGDP). We aimed to compare EMP and EGDP in outpatients, ward patients, and critically ill patients with normal upper GI anatomy.nnnMETHODSnIn 3 centers with no prior experience in EMP, patients were randomized to placement of a single-lumen nasoduodenal feeding tube either with EGDP or EMP. The primary endpoint was post-pyloric position of the tube on abdominal radiography. Patients were followed for 10 days to assess patency and adverse events. The analyses were performed according to the intention-to-treat principle.nnnRESULTSnIn total, 160 patients were randomized to EGDP (Nxa0= 76) or EMP (Nxa0= 84). Three patients withdrew informed consent, and no abdominal radiography was performed in 2 patients. Thus, 155 patients (59 intensive care unit, 38%) were included in the analyses. Rates of post-pyloric tube position between EGDP and EMP were comparable (79% vs 82%, odds ratio 1.16; 90% confidence interval, 0.58-2.38; Pxa0= .72). Adverse events were observed in 4 patients after EMP (hypoxia, GI blood loss, atrial fibrillation, abdominal pain) and in 4 after EGDP (epistaxis Nxa0= 2, GI blood loss, hypoxia). Costs of tube placements were lower for EMP compared with EGDP:

First in Human Study With a Novel Ingestible Electronic Drug Delivery and Monitoring Device: The Intellicap

519.09 versus

Validation study of automatically generated codes in colonoscopy using the endoscopic report system Endobase

622.49, respectively (Pxa0= .04).nnnCONCLUSIONSnSuccess rates and safety of EMP and EGDP in patients with normal upper GI anatomy were comparable. Lower costs and potential logistic advantages may drive centers to adopt EMP as their new standard of care. (Clinical trial registration number: NTR4286.).

371 ePill: A New Wireless Capsule with Enhanced Diagnostic and Therapeutic Potential

BACKGROUND: Highly predictable intraluminal delivery of drugs to a well-defined area of the gut may be beneficial for the development and testing of new drugs as well as for clinical use in luminal diseases of the gut and diseases requiring high drug concentrations in the portal system. We developed an ingestible electronic drug delivery and monitoring device, the IntelliCap, to meet these demands. The IntelliCap comprises a 300 μl drug reservoir, a pHand temperature sensor, a stepper motor, and a transceiver for 2-way real time wireless communication. Data are relayed via a data recorder to a computer. Changes in pH and temperature can be used to indicate the location of the IntelliCap in the gut and control drug delivery.

Sa1488 Plenary Feedback on Interhospital Differences in Quality Indicators for Colonoscopy Stimulates Quality

Abstract Objective. Gastrointestinal endoscopy databases are important for surveillance, epidemiology, quality control and research. A good quality of automatically generated databases to enable drawing justified conclusions based on the data is of key importance. The aim of this study is to validate the correctness of coding of a national automatically generated anonymous endoscopy database. Material and methods. We evaluated a total of 500 colonoscopies performed in five larger hospitals of the TRANS.IT project focusing on endoscopy reporting. Randomly 500 examinations were selected from a total of 5,000 examinations and their generated endoscopic terminology codes as well as complete reports were analysed. Indications for the examination and described findings were scored for correctness and clinical relevance of the coding that would be exported to the anonymous database. Results. Indications were correctly coded in 92% of all examinations (range 76–100%) per hospital. Correct coding of findings ranged from 42% to 93% per hospital (mean 77%). Different correct coding proportions were seen varying with the diagnosis, with the highest correct coding rates in polyps, carcinoma and diverticular disease. Incorrect coded examinations were scored for clinical relevance. Overall 11% of the investigated examinations were incorrectly coded with clinical relevance. Conclusions. Accuracy of clinically relevant endoscopy data recorded in the TRANS.IT anonymous central database is high. Further improvement is desirable, which may be achieved by education of individual endoscopists and enhancement of the program.