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临床试验/NCT05548140
NCT05548140已完成不适用

Novel Motorized Spiral Enteroscopy Vs Single Balloon Enteroscopy In Patients With Small Bowel Disorders- A Randomized Controlled Trial

Asian Institute of Gastroenterology, India4 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年9月20日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
4
主要终点
Rate of total enteroscopy (TER)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

STUDY OBJECTIVES:

  1. Primary objective: Rate of total enteroscopy (TER) by means of NMSE or SBE with: Complete antegrade approach or combined antegrade and retrograde approach

  2. Secondary objective:

  3. Technical success of anterograde and retrograde approach

  4. Procedural time (minutes)

  5. Depth of maximum insertion (cm)

  6. Diagnostic yield

  7. Therapeutic success

  8. Adverse events

详细描述

  1. INTRODUCTION: Small-bowel (SB) disorders remain a diagnostic and therapeutic challenge for endoscopists because of its unfavourable anatomy for endoscopy. It is difficult to perform deep enteroscopy of the long redundant lengthy small intestine by the bare endoscope, most of the time operator end up in pushing the SB rather than traveling through it. Last two decades saw a paradigm shift in the management of SB disorders with the introduction of deep enteroscopy1-4, including Double-balloon enteroscopy (DBE, Fujifilm, Tokyo, Japan), Single-balloon enteroscopy5 (SBE, Olympus Medical Systems Corporation, Tokyo, Japan), and Spiral enteroscopy6 (SE, Spiral Medical, LCC, USA). The DBE and SBE techniques have had varied results as far as depth of insertion is concerned; moreover, both are time-consuming and have difficult ergonomics for the endoscopist which are a major limiting factor. Spiral enteroscopy (SE)6 was introduced in 2007, which was two-operator technique where a spiral-shaped over-tube (Discovery Small Bowel, DSB) was used to pleat the small bowel over the enteroscope by manual rotation of the over tube. Deep endoscopic access to the small bowel with all available methods is still a complex, cumbersome, time-consuming procedure, and requires high endoscopic skills. Novel Motorized Spiral Enteroscope7 (NMSE, Olympus Medical, Tokyo, Japan) is a recent advancement in the field of enteroscopy. This enteroscope works on the same principle as that of SE and comes with an integrated user controlled motor in the handle of the enteroscope. The integrated electric motor is controlled with the help of a footswitch for rotating a short spiral over tube to pleat and un-pleat the small bowel. This would increase the possibility to accelerate the procedure, facilitate insertion, and simplify the technique with a single operator. The procedure can be done both by antegrade and retrograde approaches. Data is scarce on the utility, safety and efficacy of Novel Motorized Spiral Enteroscopy (NMSE) for evaluation in patients with suspected SBD by both the routes of examination. Also there are no comparative studies between SBE and NMSE. Hence we have planned a Randomized controlled trial to compare both modalities.
  2. RATIONALE: SBE is the standard procedure used for small bowel examination at our center. SBE in prior studies has shown diagnostic yield of 40-60%5 but very low TER (0-22%)4,10, with long procedure time. NMSE on the other hand has the advantage of greater TER and high diagnostic yield with shorter procedure times and minimal adverse events. Our study on NMSE11 has shown high diagnostic yield of 70%, with TER of 61% and total procedure time of around 40min. Various studies have shown the safety and efficacy of SBE and NMSE. One recent prospective study by Beyna9 et al. using NMSE for only antegrade enteroscopy showed total enteroscopy rate (TER) of 10.6% (14/132) with technical success of 97%. Majority of patients (74.2%) underwent NMSE for suspected GI bleeding. Overall diagnostic yield was 74.2% and endotherapy was done in 68.2% patients. In our study11 on NMSE, recently published, we have shown comparable technical success using both antegrade (92.85%) and retrograde (100%) routes. There was higher total enteroscopy rate of 60.6% with antegrade route showing 31.1%.This real-world scenario analysis showed that diagnostic yield of NMSE was 70% in those who successfully underwent enteroscopy and therapeutic procedures were done in almost one fourth of patients. Till date, there are no comparative data between NMSE and Balloon assisted enteroscopy techniques. Hence, we aim to compare NMSE and SBE in Randomized controlled trial.
  3. STUDY METHODS / STUDY PROCEDURE / METHODS OF ASSESSMENT: Patients presenting with symptoms and signs suggestive of small bowel disorders will be admitted and investigated as per the latest guidelines2. Patients satisfying the inclusion and exclusion criteria will be randomized in one of the two arms and will undergo either NMSE or SBE. As per the presentation and indication patients in both arms will undergo antegrade or retrograde enteroscopy. Patients undergoing antegrade enteroscopy will also undergo retrograde enteroscopy if indicated in the same sitting with the aim of total enteroscopy. Patients will be managed according to the findings and will be discharged as per the conditions. Patients will be followed up in the OPD or telephonically 1 week and after 1 month of discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Patients with small bowel disease with an indication for total enteroscopy with indeterminate imaging findings (as defined above)
  • •Age > 18 years
  • •Patients willing to give written consent

排除标准

  • •Positive imaging findings (as defined)
  • •Age < 18 years.
  • •Contraindications for endoscopy due to comorbidities
  • •Unable to provide written informed consent
  • •Patients with known severe GI tract inflammation, intestinal obstruction, gastroesophageal varices that preclude a safe enteroscopy procedure
  • •Coagulopathy or thrombocytopenia that couldn't be corrected by blood product transfusion
  • •Pregnant patients
  • •Health status American Society of Anaesthetist Classification (ASA) >3
  • •Inability to tolerate sedation or general anaesthesia for any reason
  • •Pediatrics patients (infants and toddlers)
  • •Eosinophilic esophagitis

结局指标

主要结局

Rate of total enteroscopy (TER)

时间窗: 1 year

Number of cases in which total small bowel examination can be performed

次要结局

  • Procedural time (minutes)(1 year)
  • Technical success of anterograde and retrograde approach(1 year)
  • Depth of maximum insertion (cm)(1 year)
  • Diagnostic yield(1 year)
  • Therapeutic success(1 year)
  • Adverse events(1 year)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohan Ramchandani

Consultant Gastroenterologist

Asian Institute of Gastroenterology, India

研究点 (4)

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