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

ABSTRACT: 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

DISEASE(S): Colon, Unspecified,Crohn Disease Of Small Intestine,Malignant Neoplasm Of Small Intestine,Other Vascular Disorders Of Intestine,Expected Or Proved Pathologie Of The Small Bowel

PROVIDER: 2428677 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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

Project description: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

| 2428726 | ecrin-mdr-crc

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

Diagnostic efficacy of double-balloon enteroscopy in patients with suspected isolated small bowel Crohn's disease.

Project description:BACKGROUND:Owing to the development of double-balloon enteroscopy (DBE) and video capsule endoscopy (VCE) in recent years, direct visualization of the entire small intestinal mucosa has become possible. Because of the nonspecific symptoms and the anatomic location of the small bowel, diagnosis of isolated small bowel Crohn's disease (CD) remains a challenge. The aim of this research was to explore the value of DBE for isolated small bowel CD in situations where routine tests cannot confirm the diagnosis. METHODS:This study included patients with suspected isolated small bowel CD who were hospitalized in Shengjing Hospital from April 2014 to June 2018. We included patients presenting with chronic diarrhea, abdominal pain, abdominal mass, perianal lesions, and systemic symptoms including weight loss, fever, and anemia after excluding infection factors. Patients with purely colonic CD were excluded from this cohort. Patients with suspected isolated small bowel CD underwent DBE. RESULTS:In 16/18 patients, pathological findings were detected by DBE. In 12 of the cases, small bowel CD was confirmed. The remaining four patients were diagnosed with small bowel inflammation, duodenal carcinoma, ileum inflammation and small bowel ulcers. However, the diagnosis of CD was confirmed in 14/18 (78%) patients by taking into account the clinical presentation, endoscopic and histological results as well as the experimental treatment. DBE assisted in the diagnosis in 86% (12/14) of the patients. CONCLUSIONS:In the diagnosis of small bowel CD, DBE is a helpful tool. Before assessment with DBE, clinical features, colonoscopy, and CT were used to initially assess the intestine. According to the lesions indicated by CT, we chose the most appropriate endoscope insertion route, and combined the endoscopic characteristics and pathological results of DBE to confirm the diagnosis.

| S-EPMC7045397 | biostudies-literature

A Randomized Controlled Trial Comparing the Depth of Maximal Insertion Between Anterograde Single-Balloon Versus Spiral Enteroscopy.

Project description:BackgroundThree device-assisted deep endoscopic platforms presently exist and are available for clinical use: double-balloon enteroscopy, single-balloon enteroscopy (SBE), and spiral enteroscopy (SE). In a retrospective study, SE was associated with a greater depth of maximal insertion (DMI) with similar diagnostic yields and procedure time as compared with SBE.AimsThis was a prospective, randomized comparison of SE and SBE with respect to DMI, diagnostic yield, procedure time, and rate of adverse events.MethodsPatients were prospectively randomized to undergo either anterograde SE or SBE. Patient demographics, indication for procedure, DMI, procedure time, therapeutic procedure time, adverse event, diagnostic findings, and therapeutic interventions were prospectively recorded. The primary outcome was DMI. Secondary outcomes included: procedure time; diagnostic yield; therapeutic yield and adverse event rates.ResultsDuring the study period, 30 patients underwent deep enteroscopy (SE 13, SBE 17). The most common indication was gastrointestinal bleeding in both groups. There was no significant difference in the DMI between SE and SBE (330.0 ± 88.2 cm vs 285.3 ± 80.8 cm, P = .16). There was no difference between SE and SBE in procedure time (37.0 ± 10.5 vs 38.3 ± 12.4, P = .76), diagnostic yield (SE = 9 [69%] vs SBE = 7 [41%], P = .16), or therapeutic yield (SE = 6 [46%] vs SBE = 4 [24%], P = .26). There were no major adverse events in either group.ConclusionsSpiral enteroscopy and SBE are similar with respect to DMI, diagnostic yield, therapeutic yield, procedure time, and rate of adverse events. Small numbers prevent giving a definitive judgment and future adequately powered prospective study is required to confirm these findings.

| S-EPMC5788085 | biostudies-literature

Comparison of patients' tolerance between computed tomography enterography and double-balloon enteroscopy.

Project description:BackgroundComputed tomography enterography (CTE) and double-balloon enteroscopy (DBE) are widely used in diagnosis of small bowel diseases. Both of these examinations bring discomfort to patients. The aim of this study was to compare patients' tolerance and preference between CTE and DBE.MethodsFrom August 1, 2014 to December 31, 2016, patients with suspected or known small bowel diseases who underwent both CTE and DBE were prospectively enrolled in our study. They were asked to fill out a questionnaire evaluating discomfort of the procedure after each examination.ResultsOne hundred and seven patients completed our study. Abdominal distension, painfulness, tenesmus, general discomfort, prolonged duration, difficulty in completing the test, and discomfort after the examination were significantly lower with CTE than with DBE (P<0.001, respectively). Mannitol intake (47.7%), bowel preparation (31.9%), and radiation exposure (15.0%) were regarded as the three most intolerable burdens in CTE. Painfulness (38.3%), bowel preparation (26.2%), and invasiveness (16.8%) were considered as the three most unacceptable parts of DBE. More patients (61.7%) preferred to repeat CTE rather than DBE (P<0.001).ConclusionCompared to DBE, CTE was a more tolerable and less burdensome examination and enjoyed higher preference by most patients.

| S-EPMC5652905 | 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

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

Prototype single-balloon enteroscopy with passive bending and high force transmission improves depth of insertion in the small intestine.

Project description:BACKGROUND/AIMS:We retrospectively analyzed Crohn's disease (CD) patients with small intestinal strictures who underwent single-balloon enteroscopy (SBE) to ascertain whether prototype SBEs with a passive bending mechanism and high force transmission insertion tube had better insertability in the small intestine than a conventional SBE. METHODS:Among 253 CD patients who underwent SBE, we identified 94 CD patients who had undergone attempted endoscopic balloon dilatation (EBD) for small intestinal stenosis for inclusion in this study. We analyzed whether the type of scope used for their initial procedure affected the cumulative surgery-free rate. For the insertability analysis, patients who underwent SBE at least twice were divided into 3 groups according to the type of scope used: conventional SBE only, prototype SBE only, and both conventional and prototype SBEs. For each group, depth of insertion, procedure time, and number of EBDs were compared in the same patient at different time points. RESULTS:The success rate of EBD was 88.3%. The 5- and 10-year cumulative surgery-free rate was 75.7% and 72.8%, respectively. Cox regression analysis indicated that the factors contributing to surgery were long stricture (≥2 cm), EBD failure, and elevated Crohn's Disease Activity Index, but not the type of scope used for EBD. The prototype SBEs significantly improved the depth of insertion (P=0.03, Wilcoxon's signed-rank test). CONCLUSIONS:In CD patients with small intestinal stenosis, the prototype SBEs with a passive bending mechanism and high force transmission insertion tube did not improve long-term EBD outcome but did improve deep insertability. (Clinical Trial Registration No. UMIN000037102).

| S-EPMC7206344 | biostudies-literature

A newly developed deep learning-based system for automatic detection and classification of small bowel lesions during double-balloon enteroscopy examination

Project description: Not available

| S-EPMC10759410 | biostudies-literature

A single-center United States experience with bleeding Dieulafoy lesions of the small bowel: diagnosis and treatment with single-balloon enteroscopy.

Project description:A Dieulafoy lesion (DL) of the small bowel can cause severe gastrointestinal bleeding, and presents a difficult clinical setting for endoscopists. Limited data exists on the therapeutic yield of treating DLs of the small bowel using single-balloon enteroscopy (SBE).Data were collected from Tampa General Hospital a 1 018-bed teaching hospital affiliated with University of South Florida in Tampa, Florida. Patients were selected from a database of patients that underwent SBE from January 2010 - August 2013.Eight patients were found to have DL an incidence of 2.6 % of 309 SBE performed for obscure gastrointestinal bleeding. 7/8 were identified in the jejunum, with one found in the duodenum. The mean age of patients with DL was 71.5 years old. 6/8 patients were on some form of anticoagulant/antiplatelet agent. The primary modality of therapy employed was electrocautery, multipolar electrocoagulation in seven patients and APC (argon plasma coagulation) in one patient. In three patients, electrocoagulation was unsuccessful and hemostasis was achieved with clip placement. Three patients required repeat SBE with one found to have rebleeding from a failed clip with hemostasis achieved upon reapplication of one clip.In our United States' experience, SBE offers a reasonable therapeutic approach to treat DL of the small bowel with low rates of rebleeding, no adverse events, and no patient requiring surgery.

| S-EPMC4554498 | biostudies-other

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