A prospective dual-center proof-of-principle study evaluating the incremental benefit of narrow-band imaging with a fixed zoom function in real-time prediction of polyp histology. Can we resect and discard?

BACKGROUND: Advancements in endoscopic technology have increased the ability to distinguish neoplastic polyps during colonoscopy. If a minimum accuracy can be achieved, then a resect-and-discard model can be implemented, although studies to date have demonstrated limited success, especially in the assessment of serrated polyps. OBJECTIVE: To perform a proof-of-principle study assessing the accuracy of narrow-band imaging with near focus in predicting polyp histology including serrated polyps and to determine whether the minimum requirements can be achieved for a resect-and-discard policy. DESIGN: Dual-center, prospective case series. SETTING: Two tertiary-care referral endoscopic centers in Australia. PATIENTS: Two hundred consecutive patients undergoing colonoscopy for routine indications were recruited. INTERVENTIONS: Any polyps identified were assessed by using standard white light followed by narrow-band imaging with near focus for Kudo pit patterns and modified Sano capillary patterns. Based on this assessment and the macroscopic appearance, the polyp histology was predicted and subsequently compared with histopathology results. MAIN OUTCOME MEASUREMENTS: Correlation in postpolypectomy surveillance intervals between endoscopic and pathologic assessments as well as negative predictive value for rectosigmoid hyperplastic polyps. RESULTS: There was a 96% agreement for surveillance intervals between endoscopic assessment and histology by using the American Society for Gastrointestinal Endoscopy guidelines. There was a 96% negative predictive value in assessing rectosigmoid hyperplastic polyps. LIMITATIONS: Because this was a proof-of-principle study, there was no control arm, and there were small numbers, especially in assessing subgroups. The results have limited generalizability with the training requirements for polyp recognition, with confidence to be determined. CONCLUSION: Narrow-band imaging with near focus can predict polyp histology (including serrated polyps) accurately in the hands of trained endoscopists. Further studies with larger numbers are required to further validate this practice.

Capsule endoscopy versus positron emission tomography for detection of small-bowel metastatic melanoma: a pilot study.

BACKGROUND: Melanoma is the most common tumor to metastasize to the GI tract, where it mainly involves the small bowel. OBJECTIVE: To compare capsule endoscopy (CE) and (18)F-fluorodeoxyglucose (FDG) positron emission tomography (PET)-CT scanning, the current standard and most sensitive investigation modality, in detecting small-bowel metastases in patients with metastatic melanoma. DESIGN: A prospective study of patients with metastatic melanoma who were undergoing FDG PET-CT scanning. CE was performed and the results read by two independent observers without knowledge of the other investigation results. SETTING: Tertiary care centers. PATIENTS: This study involved 21 patients with a median age of 52 years (range 22-88 years). INTERVENTION: CE. MAIN OUTCOME MEASUREMENTS: Detection of small-bowel melanoma. RESULTS: FDG PET-CT scanning showed increased abdominal uptake in 12 patients, but only 5 of these patients were found to have small-bowel melanoma on CE. Importantly, in 1 patient with a bleeding small-bowel tumor on CE, the FDG PET-CT scan result was negative. One patient with positive FDG PET-CT scan results and negative CE results subsequently developed symptomatic small-bowel melanoma 10 months after CE. LIMITATIONS: Small-bowel melanoma could not be excluded entirely in 7 patients with positive FDG PET-CT scan results and negative CE results, and follow-up is ongoing. The number of patients in this study was small. CONCLUSION: CE was better than FDG PET-CT scanning in localizing small-bowel melanoma. This study suggests that CE is an ideal complementary investigation modality for patients with known metastatic melanoma undergoing preoperative work-ups and in those with unexplained anemia or GI symptoms.

A successful practical application of Coverage with Evidence Development in Australia: Medical Services Advisory Committee interim funding and the PillCam Capsule Endoscopy Register.

BACKGROUND: In August 2002, an application for the listing on the Medicare Benefits Schedule (MBS) of PillCam Capsule Endoscopy (formally M2A) as a diagnostic procedure for obscure gastrointestinal bleeding (OGIB) was made to the Medical Services Advisory Committee (MSAC). As a result of this application, in May 2004 PillCam Capsule Endoscopy was approved with interim funding until April 2007. This funding was conditional on the collection of Australian data on the long-term safety, effectiveness, and cost-effectiveness of capsule endoscopy. METHODS: A review was conducted of how the data were collected, the methodological difficulties associated with the collection and analysis of the data, and the outcomes of the data. RESULTS: The PillCam Capsule Endoscopy Register ran from 2004 to 2007 and amassed data on 4,099 patients forming the largest database on PillCam in the world. Based on these data, in November 2007, MSAC recommended that full public funding be supported under the current MBS Item Number 11820 as capsule endoscopy is as safe as and more effective than comparable diagnostic tests. It is the preferred choice of patients and has the potential to reduce the number and cost of previous investigations. CONCLUSIONS: This form of CED proved to be ideally suited to PillCam Capsule Endoscopy. The PillCam Capsule Endoscopy Register provided data that made it possible to validate assumptions used in the economic modeling in the assessment carried out for MSAC in response to the application for funding. DISCUSSION: The use of interim funding requires both risk and cost sharing among the key players: industry, government, the medical profession, and the hospitals. Although the characteristics of PillCam Capsule Endoscopy proved to be suited to data collection, this may not be the case with other emerging health technologies. If interim funding coupled with data collection is to become an effective mechanism for bridging the evidence gap, work needs to be carried out by health technology assessment agencies to provide guidance on the design of registers so that they cater for the unique characteristics of individual procedures.

Including the questionnaire with an invitation letter did not improve a telephone survey's response rate.

OBJECTIVE: To determine whether including the study questionnaire with a letter of invitation improves the response rate in a telephone-based survey. STUDY DESIGN AND SETTING: This randomized controlled trial was part of a larger study to assess patient preferences for novel and controversial treatments for inflammatory bowel disease at Royal Prince Alfred Hospital, a tertiary referral teaching hospital in Sydney, Australia. RESULTS: Of 270 eligible patients, 124 (46%) were randomized to receive the questionnaire plus invitation whereas 146 (54%) were in the control group receiving a letter of invitation only. The consent rate was 26% for those receiving the questionnaire and 36% for the control group. The odds ratio for consent to participate among those sent the questionnaire to those not sent the questionnaire was 0.63 (95% CI=0.37-1.07). CONCLUSION: This study found that the advance mailing of a questionnaire to potential participants in a telephone survey reduced the likelihood of their participation.

Relationship between disease severity and quality of life and assessment of health care utilization and cost for ulcerative colitis in Australia: a cross-sectional, observational study.

BACKGROUND & AIMS: The burden of ulcerative colitis (UC) in relation to disease severity is not well documented. This study quantitatively evaluated the relationship between disease activity and quality of life (QoL), as well as health care utilization, cost, and work-related impairment associated with UC in an Australian population. METHODS: A cross-sectional, noninterventional, observational study was performed in patients with a wide range of disease severity recruited during routine specialist consultations. Evaluations included the Assessment of Quality of Life-8-dimension (AQoL-8D), EuroQol 5-dimension, 5-level (EQ-5D-5L), the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ), and the Work Productivity and Activity Impairment (WPAI) instrument. The 3-item Partial Mayo Score was used to assess disease severity. Health care resource utilization was assessed by chart review and patient questionnaires. RESULTS: In 175 patients, mean (SD) AQoL-8D and EQ-5D-5L scores were greater for patients in remission (0.80 [0.19] and 0.81 [0.18], respectively) than for patients with active disease (0.70 [0.20] and 0.72 [0.19], respectively, both Ps<0.001). IBDQ correlated with both AQoL-8D (r=0.73; P<0.0001) and EQ-5D-5L (0.69; P<0.0001). Mean 3-month UC-related health care cost per patient was AUD $2914 (SD=$3447 [mean for patients in remission=$1970; mild disease=$3736; moderate/severe disease=$4162]). Patients in remission had the least work and activity impairment. CONCLUSIONS: More severe UC disease was associated with poorer QoL. Substantial health care utilization, costs, and work productivity impairments were found in this sample of patients with UC. Moreover, greater disease activity was associated with greater health care costs and impairment in work productivity and daily activities.

The inability to visualize the ampulla of Vater is an inherent limitation of capsule endoscopy.

OBJECTIVE: Lesions missed by capsule endoscopy (CE) have been reported and this may be partly because of the properties of the capsule. We aimed to compare the ability of Pillcam SB1, SB2, ESO1 and ESO2 to identify the ampulla of Vater (AoV). METHODS: Patients were divided into four groups: SB1 [single head capsule, 2 frames per second (fps), a 140° field of view, n=50], SB2 (single head, 2 fps, a wider field of view of 156°, n=50), ESO1 (double head, 14 fps, a 140° field of view, n=8) and ESO2 (double head, 18 fps, an extra wide field of view of 169°, n=12). Metoclopramide was administered in 25 out of 50 patients in SB1 group and all patients in SB2 group before CE. RESULTS: The AoV was not detected in any patients having SB1, irrespective of the use of metoclopramide. The AoV was identified in only nine out of 50 (18%) patients in the SB2 group confirming the benefit of a widened field of view, however, showed that even this capsule failed to visualize the AoV in more than three-quarters of cases. Double-headed capsules with faster frame rates did not improve the detection rate, the AoV was visualized in only one out of 12 (8%) patients in the ESO2 group but none in the ESO1 studies. CONCLUSION: Currently, CE is not reliable to visualize the AoV and by inference the proximal duodenum. This is most likely related to the speed at which the capsule passes through the fixed second part of the duodenum. Faster frame rates plus a wider field of view do not overcome this limitation, which could account for missed lesions elsewhere in the small bowel.

Prospective randomized controlled trial evaluating cap-assisted colonoscopy vs standard colonoscopy.

AIM: To study the significance of cap-fitted colonoscopy in improving cecal intubation time and polyp detection rate. METHODS: This study was a prospective randomized controlled trial conducted from March 2008 to February 2009 in a tertiary referral hospital at Sydney. The primary end point was cecal intubation time and the secondary endpoint was polyp detection rate. Consecutive cases of total colonoscopy over a 1-year period were recruited. Randomization into either standard colonoscopy (SC) or cap-assisted colonoscopy (CAC) was performed after consent was obtained. For cases randomized to CAC, one of the three sizes of cap was used: D-201-15004 (with a diameter of 15.3 mm), D-201-14304 (14.6 mm) and D-201-12704 (13.0 mm). All of these caps were produced by Olympus Medical Systems, Japan. Independent predictors for faster cecal time and better polyp detection rate were also determined from this study. RESULTS: There were 200 cases in each group. There was no significant difference in terms of demographic characteristics between the two groups. CAC, when compared to the SC group, had no significant difference in terms of cecal intubation rate (96.0% vs 97.0%, P = 0.40) and time (9.94 +/- 7.05 min vs 10.34 +/- 6.82 min, P = 0.21), or polyp detection rate (32.8% vs 31.3%, P = 0.75). On the subgroup analysis, there was no significant difference in terms of cecal intubation time by trainees (88.1% vs 84.8%, P = 0.40), ileal intubation rate (82.5% vs 79.0%, P = 0.38) or total colonoscopy time (23.24 +/- 13.95 min vs 22.56 +/- 9.94 min, P = 0.88). On multivariate analysis, the independent determinants of faster cecal time were consultant-performed procedures (P < 0.001), male patients (P < 0.001), non-usage of hyoscine (P < 0.001) and better bowel preparation (P = 0.01). The determinants of better polyp detection rate were older age (P < 0.001), no history of previous abdominal surgery (P = 0.04), patients not having esophagogastroduodenoscopy in the same setting (P = 0.003), trainee-performed procedures (P = 0.01), usage of hyoscine (P = 0.01) and procedures performed for polyp follow-up (P = 0.01). The limitations of the study were that it was a single-center experience, no blinding was possible, and there were a large number of endoscopists. CONCLUSION: CAC did not significantly different from SC in term of cecal intubation time and polyp detection rate.

Capsule endoscopy in patients with malignant melanoma.

BACKGROUND: Although small bowel (SB) involvement is found at postmortem in 50-60% of melanoma patients, diagnosis is only made during life in 10% of cases. This study reports the findings of capsule endoscopy (CE) in melanoma patients referred for investigation of suspected SB involvement. METHODS AND SUBJECTS: Eight men and five women with known or previous melanoma were referred for CE between December 2003 and September 2006. The indications were gastrointestinal bleeding (three), anemia (six), positive fecal occult blood test (one), abnormal imaging (two), and abdominal pain (one). RESULTS: CE showed SB metastases in five patients and excluded SB involvement in eight. All patients had previous investigations with either endoscopy, push enteroscopy, SB follow-through, CT scan, and/or PET scan. CE showed new lesions not detected by other investigation modalities. CE also ruled out SB metastases when other tests were nondiagnostic. All five patients with SB metastases detected underwent surgical resection. At follow-up after CE of a mean 8.4 months (1-23 months) and 4.9 months (0.25-10 months) after surgery, five patients had died, including three of those who had undergone resection of SB metastases. Seven patients were still alive, including two who had SB surgery. One patient was lost to follow-up. CONCLUSIONS: CE may detect the presence and extent of SB metastases in patients with melanoma more reliably than conventional investigations. It should be considered in the workup of melanoma patients with suspected SB disease.

Diagnosis and outcome of small bowel tumors found by capsule endoscopy: a three-center Australian experience.

OBJECTIVE: The objective of the study was to examine diagnosis and outcome in a series of patients with small bowel tumors detected by capsule endoscopy (CE) in three Australian centers. METHODS: Review of prospectively collected data from 416 CEs identified 27 tumors in 26 patients. Clinical parameters, tumor histology, and follow-up are reported. RESULTS: Twenty-seven tumors were identified in 26 patients (mean age 61 +/- 13.7 yr). Indications for CE were obscure gastrointestinal (GI) bleeding (21), suspected tumor (3), abdominal pain (1), diarrhea (1). Prior radiology found a possible lesion in 8 of 23 (35%). Nine tumors were proven benign: hamartoma (4), cystic lymphangioma (1), primary amyloid (1), lipoma (1). Two lesions were non-neoplastic: heterotopic gastric mucosa and inflammatory fibroid polyp. Seventeen tumors were malignant: five adenocarcinomas, six carcinoids, two melanoma metastases, two gastrointestinal stromal tumors (GIST), one colon carcinoma metastasis, one non-Hodgkin's lymphoma. Tumors were surgically resected in 23 patients. Resection was considered curative in 12 (52%). Mean duration of follow-up was 26 +/- 13.7 months. Of the five patients with primary adenocarcinoma only one remains disease free. Three of the six with carcinoid tumors have had no recurrence up to 51 months postresection. Both patients with GIST are disease free. Anemia resolved after surgery in the patients with melanoma. CONCLUSIONS: Small bowel tumors are a significant finding at CE and are often missed by other methods of investigation. In many patients, detection of a tumor alters management and improves outcome. Even in malignant lesions, treatment is potentially curative in the absence of metastatic disease.

Appendectomy protects against the development of ulcerative colitis but does not affect its course.

OBJECTIVES: Appendectomy has been shown to protect against the development of ulcerative colitis. The objective of this study was to examine the effect of appendectomy on the clinical features and natural history of colitis. METHODS: A total of 259 consecutive adults patients with ulcerative colitis were studied. Of the patients, 20 had undergone appendectomy (12 before onset of colitis and eight after diagnosis). RESULTS: The frequency of appendectomy was significantly less than in a group of 280 controls, which comprised partners of the patients and a group from the community (OR = 0.25; 95% CI = 0.14-0.44). This was even more significant if only the 12 patients who underwent surgery before the onset of colitis were considered (OR = 0.15; 95% CI = 0.07-0.28). Patients with prior appendectomy developed symptoms of ulcerative colitis for the first time at a significantly later age than those without appendectomy (42.5 +/- 6.5 vs 32.1 +/- 0.8 yr; p < 0.01) or those who had appendectomy after the onset of colitis (24.6 +/- 3.4 yr; p < 0.05). Appendectomy did not influence disease extent, need for immunosuppressive treatment with azathioprine or 6-mercaptopurine (as a marker of resistant disease), or the likelihood of colectomy. Five patients in the appendectomy group had clinical evidence of primary sclerosing cholangitis (25%). This was more common than in those without appendectomy (8%; OR = 4.09; 95% CI = 1.04-13.60). CONCLUSIONS: These results indicate that although appendectomy may delay onset of colitis, it does not influence its course. However, it is associated with the development of primary sclerosing cholangitis. Appendectomy is unlikely to be of benefit in established ulcerative colitis.