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Prospective singlecenter trial comparing the efficiency of Spiral Enteroscopy (SE) and Double Balloon Enteroscopy (DBE) in patients with small bowel disorders

ABSTRACT: Interventions: Group 1: double balloon enteroscopy (oral +/- anal route) Group 2: spiral enteroscopy (oral +/- anal route) Primary outcome(s): Our goal is to investigate whether complete enteroscopies are achieved 12 times as frequent using DBE or SE. Study Design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: diagnostic

DISEASE(S): Crohn Disease Of Small Intestine,Suspected Or Known Small Bowel Disease,Vascular Disorders Of Intestine,Malignant Neoplasm Of Small Intestine,Gastrointestinal Haemorrhage, Unspecified

PROVIDER: 2428726 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Prospective multicenter trial comparing Double Balloon enteroscopy (DBE) and Single balloon enteroscopy (SBE) in patients with small bowel disorders

Project description:Interventions: Group 1: double ballon enteroscopy Group 2: single ballon enteroscopy Primary outcome(s): complete enteroscopy Study Design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: diagnostic

| 2428677 | ecrin-mdr-crc

Data Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Routine Care Procedures (GPS Study)

Project description:A prospective, multicenter, post-market, minimal risk, observational study designed to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical centers in the United States (US).

| 2740369 | ecrin-mdr-crc

Examination of clinical utility of XX-45(double-balloon enteroscope)

Project description:Interventions: Insertion of XX-45 via an oral and/or anal route Primary outcome(s): - Whether or not the objectives of the examination were achieved - Incidence of adverse events Study Design: Single arm Non-randomized

| 2620578 | ecrin-mdr-crc

GI Organ Tracking Via Balloon Applicators

Project description:The hypothesis of this study is that an occlusion balloon catheter placed in the stomach via an oral or nasogastric route will be safe and permit tracking of the stomach during radiation therapy.

| 2742746 | ecrin-mdr-crc

How does tolerability of double balloon enteroscopy compare to other forms of endoscopy?

Project description:Background and aimsGastrointestinal endoscopy can be difficult for patients to tolerate. Studies on endoscopic tolerability mainly focus on gastroscopy or colonoscopy with a paucity of data on double balloon enteroscopy (DBE). We aimed to prospectively evaluate tolerability in patients undergoing several forms of endoscopy including DBE.MethodsConsecutive patients undergoing colonoscopy, flexible sigmoidoscopy, gastroscopy, endoscopic retrograde pancreatography (ERCP), capsule endoscopy (CE) and DBE were prospectively recruited. A questionnaire recorded demographics, procedural data, patient tolerability (pain, discomfort and distress recorded on numerical rating scales) and the Hospital Anxiety and Depression Scale (HADS).Results956 patients were recruited (512 women; median age 57 years). The median pain score for DBE was poor with a score of 5 compared with 1 and 0 for oesophagogastroduodenoscopy and ERCP, respectively (p<0.001). Colonoscopy and retrograde DBE scores were not dissimilar. CE was well tolerated with a median pain score of 0. Patients with DBE required significantly higher doses of sedation and analgesia than other patients. The HADS Anxiety Score was also associated with poorer tolerability.ConclusionsDBE is poorly tolerated when compared with other forms of endoscopy despite higher doses of sedation. Increasing demand to improve tolerability of DBE in the UK may be addressed with the use of propofol.

| S-EPMC5369540 | biostudies-literature

Cholangioscopy and double-balloon enteroscopy mediated "sandwich puncture" of a completely closed choledochojejunostomy.

Project description:Video 1Percutaneous cholangioscopy was performed to confirm complete closure of the choledochojejunostomy. Percutaneous cholangioscopy revealed complete closure of the anastomosis. Our attempt to pass a guidewire through the anastomosis failed accordingly.

| S-EPMC8267955 | biostudies-literature

Comparison of the Efficacy and Safety of Single- versus Double-Balloon Enteroscopy Performed by Endoscopist Experts in Single-Balloon Enteroscopy: A Single-Center Experience and Meta-Analysis.

Project description:Studies concerning the efficacy and safety of single-balloon enteroscopy (SBE) compared with that of double-balloon enteroscopy (DBE) often appear to be conflicting. However, previous studies were performed by endoscopists who were less experienced in SBE compared with DBE.We performed a retrospective analysis of SBE and DBE data performed by a single enteroscopist, with expertise in SBE, using a prospective balloon-assisted enteroscopy registry from 2013 to 2015. Furthermore, we performed a comprehensive literature search and meta-analysis of available studies, including the current study, to clarify the efficacy and safety of SBE versus DBE.A total of 65 procedures in 44 patients with SBE and 74 procedures in 69 patients with DBE were analyzed. There were no significant differences in diagnostic yield (61.1% vs 77.3%, respectively, p=0.397), therapeutic yield (39.1% vs 31.8%, respectively, p=0.548), and complication rate (4.4% vs 2.3%, p=1.000). In the meta-analysis, which included four randomized controlled trials and three observational studies, there were no significant differences in the pooled relative risk and odds ratio for diagnostic and therapeutic yield and complications of SBE compared with those of DBE.The performance of SBE appears to be similar to that of DBE in terms of diagnostic and therapeutic yield and complications.

| S-EPMC5491087 | biostudies-other

Single-balloon enteroscopy: results from an initial experience at a U.S. tertiary-care center.

Project description:Single-balloon enteroscopy (SBE) is a novel, deep-enteroscopy modality for diagnosis and treatment of disorders of the small bowel.The aim of the study was to examine the performance, yield, and safety of SBE in the initial experience at a tertiary-care center.Retrospective analysis of all SBEs during a 10-month period in 2008. Data were extracted from electronic clinical and endoscopy records.U.S. tertiary-care center.All patients referred to our center for SBE during the study period were included in the current analysis.SBE.Anterograde SBE procedure time, diagnostic yield, and complications.Thirty-eight anterograde SBEs were performed. The mean patient age was 62 years (42% female). Patients were referred for GI bleeding (97%), Crohn's disease, suspected polyps or neoplasia, and abnormal capsule endoscopy results. The mean (+/- SD) procedure time was 49 +/- 19 minutes. The estimated depth of insertion was proximal jejunum (34%), mid-jejunum (45%), and distal jejunum (21%). The SBE diagnostic yield was 47%, with significant findings in 18 patients. Findings included angiectasias, bleeding, abnormal mucosa, ulceration, polyps, and a foreign body. The therapeutic yield was 42%, with lesion ablation performed in 24% of cases. Diagnostic biopsies were performed in 24% of cases and tattooing in 52%. There were no significant complications.Single-center, retrospective study.Single-balloon enteroscopy appears to be a safe and efficient method for examination of the mid-small bowel. The significant therapeutic yield (42%) suggests that comparative studies with double-balloon and spiral enteroscopy are warranted.

| S-EPMC4751863 | biostudies-literature

Magnified single-balloon enteroscopy in the diagnosis of intestinal follicular lymphoma: a case series.

Project description:The objective of this study was to evaluate the magnified endoscopic findings in the diagnosis of follicular lymphoma in the small intestine in comparison with those of intestinal follicular lymphoma and lymphangiectasia. Four patients with follicular lymphoma and 3 with lymphangiectasia in the small intestine were retrospectively analyzed. A prototype magnifying singleballoon enteroscope was used. The findings of the intestinal follicular lymphoma and lymphangiectasia were retrospectively analyzed to determine the magnified endoscopic findings of follicular lymphoma in the small intestine. Opaque white granules were observed in 3 of the 4 patients with follicular lymphoma. Magnified narrow-band imaging (NBI) of the opaque white granules showed stretched microvessels, which had a diminutive tree-like appearance. The remaining patient had no opaque white granules and only displayed whitish villi. Magnified NBI observation of the whitish villi revealed the absence of marginal villus epithelium, which was confirmed by histology. The magnified NBI enteroscopy revealed the diminutive tree-like appearance on the opaque white granules and the absence of marginal villus epithelium of the whitish villi in intestinal follicular lymphoma. These findings may be useful in diagnosing follicular lymphoma.

| S-EPMC6223446 | biostudies-literature

The Use of Balloon-assisted Enteroscopy at a Large Volume Centre: A Retrospective Analysis.

Project description:ObjectivesBalloon-assisted enteroscopy (BAE) is increasingly used for the evaluation of small bowel disorders. We quantified local diagnostic and therapeutic yields of BAE in patients with suspected small bowel diseases.MethodsAdult patients undergoing BAE between January 2010 and July 2015 at McGill University Health Centre were included. Procedures were identified using a prospectively maintained database. Patients were excluded if procedure report was unavailable. Electronic medical records were reviewed. Analyses were restricted to patients who did not have a previous BAE.ResultsBAE was performed in 453 patients, including 421 anterograde cases. Patients had a mean age of 61.0 ± 17.5 years. Most common indications for referral were obscure gastrointestinal bleeding (OGIB) (n=207, 45.7%), abnormal imaging (n=88, 19.4%), suspected small bowel neoplasia (SBN) (n=39, 8.6%) and Crohn's disease (CD) (n=31, 6.8%). A diagnosis was established in 216 procedures (47.7%). A pre-endoscopic indication of CD (odds ratio [OR]: 3.78; 95% Confidence Interval [CI], 1.60-8.90), OGIB (OR: 3.69, 95% CI, 2.03-6.71), suspected SBN (OR: 2.45; 95% CI, 1.06-5.65) and previous VCE (OR: 9.33; 95% CI, 3.24-26.90) were associated with abnormal findings. A therapeutic procedure was performed in 126 cases (28.3%). OGIB (OR: 7.00; 95% CI, 3.83-12.81), previous video capsule endoscopy (VCE) (OR: 7.86; 95% CI, 2.93-21.04) and suspected SBN (OR: 6.30; 95% CI, 2.58-21.04) were associated with performance of a therapeutic intervention. Complication rate was 1.6%, with bleeding in seven cases and one perforation.ConclusionsIn carefully selected patients, such as those with OGIB, Crohn's disease and previous VCE, BAE was a safe procedure that led to the identification of abnormal findings and therapeutic interventions.

| S-EPMC6488007 | biostudies-literature

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