Nationwide multicenter study on adverse events associated with a patency capsule: Additional survey of appropriate use of patency capsule study.

BACKGROUND AND AIM: The PillCam patency capsule (PC) without a radio frequency identification tag was released to preclude retention of the small bowel capsule endoscope (CE) in Japan in 2012. We conducted a multicenter study to determine tag-less PC-related adverse events (AEs). METHODS: We first conducted a retrospective survey using a standardized data collection sheet for the clinical characteristics of PC-related AEs among 1096 patients collected in a prospective survey conducted between January 2013 and May 2014 (Cohort 1). Next, we retrospectively investigated additional AEs that occurred before and after Cohort 1 within the period June 2012 and December 2014 among 1482 patients (Cohort 2). RESULTS: Of the 2578 patients who underwent PC examinations from both cohorts, 74 AEs occurred among 61 patients (2.37%). The main AEs were residual parylene coating in 25 events (0.97%), PC-induced small bowel obstruction, suspicious of impaction, in 23 events (0.89%), and CE retention even after patency confirmation in 10 events (0.39%). Residual parylene coating was significantly associated with Crohn's disease (P < 0.01). Small bowel obstruction was significantly associated with physicians with less than 1 year of experience handling the PC and previous history of postprandial abdominal pain (P < 0.01 and P < 0.03, respectively). CE retention was ascribed to erroneous judgment of PC localization in all cases. CONCLUSIONS: This large-scale multicenter study provides evidence supporting the safety and efficiency of a PC to preclude CE retention. Accurate PC localization in patients without excretion and confirmation of previous history of postprandial abdominal pain before PC examinations is warranted (UMIN000010513).

[Usefulness and safety of observing anorectal lesions by colon capsule endoscopy].

We investigated the findings of rectoanal lesions in 190 patients who underwent colon capsule endoscopy (CCE) at our hospital. Internal hemorrhoids were observed in 70 (36.8%) patients and rectal polyps in 19 (10%) patients. When conventional endoscopy (colonoscopy and double balloon endoscopy) was considered the gold standard, the sensitivity and specificity of rectal polyps were 75% and 93.4%, respectively, and those of internal hemorrhoids were 88.9% and 92.7%, respectively. The prevalence of constipation was significantly higher in the false-negative group for internal hemorrhoids, and the colonic transit time was significantly shorter in the false-negative and false-positive groups for rectal polyps. No adverse events occurred in any of the patients. CCE might be a useful and safe examination method for rectoanal lesions.

Safety and efficacy of the endoscopic delivery of capsule endoscopes in adult and pediatric patients: Multicenter Japanese study (AdvanCE-J study).

BACKGROUND AND AIM: We retrospectively determined the safety and efficacy of the endoscopic delivery (ED) of capsule endoscopes. METHODS: We enrolled 10,156 patients who underwent small bowel capsule endoscopy (SBCE), 3182 who underwent patency capsule (PC), and 1367 who underwent colon capsule endoscopy (CCE), at 11 gastroenterological and nine pediatric centers. RESULTS: Small bowel capsule endoscopies, PCs, and CCEs were endoscopically delivered to 546 (5.4%), 214 (6.7%), and 14 (1.0%) patients, respectively. Only mild complications occurred for 21.6% (167/774), including uneventful mucosal damage, bleeding, and abdominal pain. Successful ED of SBCE to the duodenum or jejunum occurred in 91.8% and 90.7% of patients aged <16 years and ≥16 years, respectively (P = 0.6661), but the total enteroscopy rate was higher in the first group (91.7%) than in the second (76.2%, P < 0.0001), for whom impossible ingestion (87.3%) was significantly more common than prolonged lodging in the stomach (64.2%, P = 0.0010). Successful PC and CCE delivery to the duodenum occurred in 84.1% and 28.6%, thereafter the patency confirmation rate and total colonoscopy rate was 100% and 61.5%, respectively. The height, weight, and age cutoff points in predicting spontaneous ingestion were 132 cm, 24.8 kg, and 9 years 2 months, respectively, in patients aged <16 years. Patients aged ≥16 years could not swallow the SBCEs mainly due to dysphagia (75.0%); those who retained it in the esophagus due to cardiac disease (28.6%), etc. and in the stomach due to diabetes mellitus (15.7%), etc. CONCLUSIONS: This large-scale study supports the safety and efficacy of ED in adult and pediatric patients. UMIN000042020.

Tag-less patency capsule for suspected small bowel stenosis: Nationwide multicenter prospective study in Japan.

STUDY AIMS: The PillCam patency capsule (PPC) is an Agile tag-less patency capsule used to evaluate gastrointestinal (GI) patency. We determined the appropriate use of PPC to preclude subsequent small bowel capsule endoscopy (SBCE) retention. METHODS: This prospective multicenter study consecutively enrolled patients indicated for SBCE with suspected or established small bowel stenosis. Excretion of an intact PPC or its radiologic visualization in the large bowel was considered GI patency. Primary and secondary study endpoints were SBCE retention rates in patients with confirmed patency and identification of factors associated with patency and SBCE retention, respectively. RESULTS: Of 1096 patients enrolled in the study, patency was confirmed in 976 (89.1%). PPC excretion occurred in 579 patients. Of the remaining 517 patients, patency was confirmed using imaging modalities in 401 (77.5%). SBCE retention occurred in five (0.51%) of 963 patients who underwent SBCE: 1.0% in established Crohn's disease (CD) patients, 0% in suspected CD, 0% in tumors, and 1.6% in patients with obscure GI bleeding, for which PPC localization had been radiographically misinterpreted. The non-confirmation of patency was associated with established CD, stenosis identified using imaging modalities, abdominal fullness, serum albumin levels <4.0 g/dL, and previous small bowel obstruction (adjusted odds ratios: 4.21, 2.60, 2.47, 2.12, and 2.00; 95% confidence intervals: 2.62-6.78, 1.62-4.17, 1.43-4.27, 1.32-3.40, and 1.15-3.47, respectively). CONCLUSIONS: The PillCam™ patency capsule helped preclude SBCE retention in most patients, but its accurate localization was essential for cases without excretion (Study registered the University Hospital Medical Information Network, #UMIN000010513).

[A case of melena and perforation during chemotherapy for peripheral T-cell lymphoma, not otherwise specified of the small intestine].

A 71-year-old male presented with gastrointestinal bleeding. Double-balloon endoscopy revealed diffuse thickening of the wall and a shallow ulcer measuring approximately 10cm in the mid jejunum. Biopsy revealed diffuse proliferation of large lymphoid cells that were immunohistochemically positive for CD3, CD5, and bcl-2 but negative for CK, CD10, CD20, and bcl-6. The cyclin D1 labeling index was 3% and the MIB-1 labeling index was 61%. On the basis of these findings, he was diagnosed with peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) of the small intestine. Following four courses of THP-COP chemotherapy, he developed intestinal perforation and underwent partial resection of the small intestine. He is currently undergoing further chemotherapy.

Follow-up outcomes in patients with negative initial colon capsule endoscopy findings.

BACKGROUND: Colon capsule endoscopy (CCE), which became clinically applicable in 2006, is a simple and noninvasive procedure to evaluate colonic diseases; the accuracy of second-generation CCE, introduced in 2009, has dramatically improved. Currently, CCE is used as an alternative method for colorectal cancer screening, as well as for evaluating the mucosal lesions of inflammatory bowel disease, in cases where performing colonoscopy (CS) is difficult. However, the outcomes of CCE are uncertain. AIM: To investigate the outcomes of Japanese patients with negative findings (no polyps or colorectal cancer) on initial CCE. METHODS: This retrospective, single-center study was conducted at the Endoscopic Center at Aishinkai Nakae Hospital. This study included patients who underwent continuous CCE between November 2013 and August 2019, that exhibited no evidence of polyps or colorectal cancer at the initial CCE, and could be followed up using either the fecal immunochemical test (FIT), CS, or CCE. The observational period, follow-up method, presence or absence of polyps and colorectal cancer, pathological diagnosis, and number of colorectal cancer deaths were evaluated. RESULTS: Thirty-one patients (mean age, 60.4 ± 15.6 years; range, 28-84 years; 14 men and 17 women) were enrolled in this study. The reasons for performing the first CCE were screening in 12, a positive FIT in six, lower abdominal pain in nine, diarrhea in two, and anemia in two patients. The mean total water volume at the time of examination was 3460 ± 602 mL (2250-4800 mL), and a total CS was performed in 28 patients (90%). The degree of cleanliness was excellent in 15 patients and good in 16, and no poor cases were observed. No adverse events, such as retention or capsule aspiration, were observed in any of the patients. The mean follow-up period was 3.1 ± 1.5 years (range, 0.3-5.5 years). Follow-up included FIT in nine, CS in 20, and CCE in four patients (including duplicate patients). The FIT was positive in two patients, while CS revealed five polyp lesions (three in the ascending colon, one in the transverse colon, and one in the descending colon), with sizes ranging between 2 mm and 8 mm. Histopathological findings revealed a hyperplastic polyp in one patient, and adenoma with low grade dysplasia in four patients; colorectal cancers were not recognized. In the follow-up example by CCE, polyps and colorectal cancer could not be recognized. During the follow-up period, there were no deaths due to colorectal cancer in any of the patients. CONCLUSION: We determined the outcomes in patients with negative initial CCE findings.

Evaluation of Performance in Colon Capsule Endoscopy Reading by Endoscopy Nurses.

Background: Although there are papers reporting on the accuracy of colon capsule endoscopy (CCE) compared with colonoscopy (CS), there are few reports on the detection rates of significant lesions by endoscopy nurses. We previously reported no significant difference in the detection rates for small bowel capsule endoscopy (SBCE) images among two well-trained physicians and one expert nurse. Objective: To evaluate the reading time and detection rate of the significant lesions of CCE images among novice and trained expert endoscopy nurses and novice physicians. Methods: CCE videos of 20 consecutive patients who performed both CCE and CS with clinically significant localized lesions were selected. Two trained expert endoscopy nurses, untrained two novice physicians, and novice three endoscopy nurses reviewed CCE videos. The detection rate of the lesions and reading time were compared among the three groups and were evaluated by comparison between the first and the second 10 videos. Results: The median reading time was the shortest (19 min) in the trained expert endoscopy nurses and the longest (45 min) in the novice nurses. The number of thumbnails tended to be more in the trained expert endoscopy nurses in the first 10-video reading. Although the detection rates of small polyps (<5 mm) were significantly lower (46.5%, p=0.025) in the novice nurses compared to the others, they were improved (35.2% to 63.5%, p=0.015) in the second 10 videos. The detection rates of tumor lesions by either one of two trained expert endoscopy nurses were higher compared to those by each novice physician. Conclusions: The trained expert endoscopy nurses for CCE reading can reduce physician's time and improve the diagnostic yield.

Castor oil as booster for colon capsule endoscopy preparation reduction: A prospective pilot study and patient questionnaire.

BACKGROUND: Preparation for colon capsule endoscopy (CCE) requires a large liquid laxative volume for capsule excretion, which compromises the procedure's tolerability. AIM: To assess the safety and utility of castor oil-boosted bowel preparation. METHODS: This prospective cohort study including 20 patients (age range, 16-80 years; six men and 14 women) suspected of having colorectal disease was conducted at Kindai University Hospital from September 2017 to August 2019. All patients underwent CCE because of the following inclusion criteria: previous incomplete colonoscopy in other facility (n = 20), history of abdominal surgery (n = 7), or organ abnormalities such as multiple diverticulum (n = 4) and adhesion after surgery (n = 6). The exclusion criteria were as follows: Dysphagia, history of allergic reactions to the drugs used in this study (magnesium citrate, polyethylene glycol, metoclopramide, and castor oil), possibility of pregnancy, possibility of bowel obstruction or stenosis based on symptoms, or scheduled magnetic resonance imaging within 2 wk after CCE. The primary outcome was the capsule excretion rate within the battery life, as evaluated by the total large bowel observation rate, large bowel transit time, and bowel creasing level using a five-grade scale in different colorectal segments. The secondary outcomes were complications, colorectal lesion detection rates, and patients' tolerability. RESULTS: The castor oil-based regimen was implemented in 17 patients. Three patients cancelled CCE because they could tolerate castor oil, but not liquid laxatives. The capsule excretion rate within the battery life was 88% (15/17). The mean large bowel transit time was 236 min. Approximately 70% of patients had satisfactory colon cleansing levels. CCE detected colon polyps (14/17, 82%) and colonic diverticulum (4/12, 33%). The sensitivity, specificity, and diagnostic accuracy rates for detecting colorectal polyps (size ≥ 6 mm) were 76.9%, 75.0%, and 76.4%, respectively. The sensitivity, specificity, and diagnostic accuracy rates for detection of diverticulum were 100% each. Twelve patients (71%) rated CCE as more than "good", confirming the new regimen's tolerability. No serious adverse events occurred during this study. CONCLUSION: The castor oil-based regimen could reduce bowel preparation dose and improve CCE tolerability.

Colon Capsule Endoscopy in Detecting Colonic Diverticula in a Japanese Population.

Objective The assessment of colonic diverticula with colon capsule endoscopy (CCE) in a Japanese population provided unclear results. In this study, we retrospectively reviewed a cohort of Japanese patients who had undergone CCE to assess its safety and usefulness in the diagnosis of colonic diverticula. Methods In this study, 175 consecutive Japanese patients who had their entire colon observed via CCE from November 2013 to July 2018 were included. Patients were retrospectively stratified according to age, gender, colonic segment, and symptoms involvement. A multivariable regression analysis was performed to investigate the presence of any correlation among variables. The safety of CCE was assessed in terms of the incidence of adverse events (AEs). Results Colonic diverticula were observed in 42.3% of all cases; of those; 36.5% were right-sided, 31.1% were left-sided, and 32.4% were bilateral. Moreover, one to two colonic diverticula were observed in 35.1%, while three or more diverticula were seen in 64.9%. Multivariable analysis showed that age (≥70 years) was positively associated with colonic diverticula, while male gender and the presence of colonic polyps were negatively associated with colonic diverticula. No correlation was found between colonic diverticula and symptoms. There was no significant difference between groups with and without colonic diverticula in the incidence of AEs. AEs were mild in severity, with no severe AE-related bowel preparation and capsule ingestion reported. Conclusion CCE was well-tolerated by the participants, and the incidence of colonic diverticula was 42.3%, with one to two and three or more diverticula being found in 35.1% and 64.9%, respectively. There was little difference in the frequency of colonic diverticula formation on the right side, left side, and on both sides. Age was a positive association factor, while male gender and the presence of colorectal polyps were negative association factors. No correlation was found between diverticula and symptoms.

A case of rectal villous tumor with shortness of breath in a 70-year-old woman-Uncommon symptom of McKittrick-Wheelock syndrome.

Diagnosis of McKittrick-Wheelock syndrome (MWS) is sometimes difficult because the symptoms are sometimes nonspecific. Physician should be considered MWS in case of severe hyponatremia and hypokalemia are accompanied by prolonged mucous diarrhea.

Effects in the control of edema of the papilla of Vater by epinephrine saline irrigation after endoscopic retrograde cholangiopancreatography in an endoscopy center in Japan, 2003 to 2007: exploratory retrospective analysis to evaluate the characteristics of eligible patients with a focus on serum amylase levels.

OBJECTIVE: To evaluate the effects of localized irrigation with epinephrine saline after endoscopic retrograde cholangiopancreatography (ERCP). PATIENTS AND METHODS: One hundred and fourteen patients who underwent ERCP in our institute were treated with or without irrigation using epinephrine diluted in saline after ERCP to prevent post-ERCP pancreatitis. The serum amylase levels, white blood cell counts, and urine amylase levels were measured at 24 and 48 hours after ERCP. RESULTS: The treatment resulted in improvements in all items. A univariate analysis of the explanatory variables between the treatment and untreated groups revealed the treatment to be effective, but not statistically significant. Gender and cannulation of the pancreatic duct were the only variables with significant partial regression coefficients in the multiple regression model with all explanatory variables (p=0.045). When a stratified analysis was conducted using gender as a moderator variable, the treatment became a significant preventive factor (p=0.038), and cannulation of the pancreatic duct was a significant risk factor (p=0.027) in female patients. CONCLUSION: We suggest that irrigating with epinephrine saline into the papilla may be effective for preventing pancreatitis in female patients who received ERCP with cannulation of their pancreatic duct.