Clinical trial NCT04959994: Small Bowel Evaluation Using Novel Motorized Spiral Enteroscopy
Official title: Small Bowel Evaluation Using Novel Motorized Spiral Enteroscopy - Prospective Non-controlled Clinical Study From a Single Tertiary Care Centre.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Bowel Disease
Keywords: Small bowel disease
Deep enteroscopy
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with suspected small bowel disease satisfying the inclusion criteria and have indications for total enteroscopy will undergo small bowel evaluation using Novel Motorized Spiral Enteroscopy.

Brief summary: Small bowel evaluation using Novel Motorized Spiral Enteroscopy - Prospective non-controlled clinical study from a single tertiary care centre.

Data regarding the safety and efficacy of Novel Motorized Spiral Enteroscopy in the evaluation of the small bowel, most of them are retrospective. This study is being planned to collect the data prospectively for all the patients undergoing this procedure at our center including the follow up at 1 month for any adverse events.This will enlighten us in understanding the role of Novel Motorized Spiral in the evaluation of the small bowel Enteroscopy in the small bowel evaluation.

Detailed description: 1. Introduction Few studies have been published till now regarding the safety and efficacy of Novel Motorized Spiral Enteroscopy in the evaluation of the small bowel, most of them are retrospective. This study is being planned to collect the data prospectively for all the patients undergoing this procedure at our centre including the follow up at 1 month for any adverse events. This will help us to develop our understanding the role of Novel Motorized Spiral Enteroscopy in the small bowel evaluation.
2. Rationale Prospective study evaluating the efficacy of the Novel Motorized Spiral Enteroscopy is lacking. This study will help in understanding the efficacy and safety of the procedure in the evaluation of the small bowel diseases.
3. Study Population All the patients who will undergo small bowel evaluation using Novel Motorized Spiral Enteroscopy at AIG Hospitals, Gachibowli, Hyderabad, Telangana, India
4. Methodology Patients with suspected small bowel disease with an indication for total enteroscopy will undergo Novel Motorized Spiral Enteroscopy at AIG hospitals. Patient record including the Demographic details, Indications, Pre-Anaesthesia evaluation, History of any previous surgery or prior enteroscopy. Procedure technical success, Total enteroscopic small bowel evaluation rate or extent of examination. Therapeutic procedure underwent, Total Procedure time, Diagnosis, Recovery from anaesthesia time record will be maintained. All the patients will be followed up telephonically for any possible adverse event upto 30 days.

Patient details will be recorded in a proforma after taking proper informed consent.

4a. Inclusion Criteria

1. Patients with small bowel disease with an indication for Motorized spiral enteroscopy
2. Overt or obscure Gastrointestinal bleeding
3. Iron deficiency anaemia
4. Chronic diarrhoea
5. Abdominal pain for evaluation with suspected small bowel involvement.
6. IBD requiring small bowel evaluation
7. Polyposis syndrome requiring small bowel evaluation
8. Small bowel subacute obstruction
9. Refractory celiac disease

4b. Exclusion criteria

1. Weight less than 30 kg
2. Large gastric or oesophageal varices
3. Any medical contraindication to standard enteroscopy
4. Any prior history of gastric , small bowel , large bowel surgery
5. Acute obstruction of small bowel
6. Suspected GI perforation
7. Any contraindication for general anaesthesia
8. Lack of informed consent.

4c. Subject recruitment All the patients who will undergo the procedure according to the inclusion and exclusion criteria will be taken. Prospectively their records will be maintained by proforma at AIG hospitals, Gachibowli.

4d. Randomization and blinding - NIL Single group assignment with no randomization

4e. Method of assessment This will be a non- controlled single group assignment study,All antegrade power spiral enteroscopy procedures will be performed under elective general anesthesia with nasotracheal intubation.Retrograde power spiral enteroscopy procedures will be performed under deep sedation using propofol.A prophylactic wire guided dilatation using Savary - Gilliard dilator up to 20 mm will be done in all the patients. After the maximal depth of insertion via the antegrade route hemoclip or Indiaink will be applied to mark the maximal depth of insertion and retrograde enteroscopy will be done to try to trace the hemoclip on the same or the next day to obtain total enteroscopy.

4f. Stopping or discontinuation criteria- None

5. Sample size calculation All the patients who will undergo Novel Motorized Spiral Enteroscopy will be recorded in a proforma and their follow up at 30 days will be assessed telephonically for a duration of 1 year

6. Statistical analysis The database will be created with Microsoft Excel (Microsoft, Seattle, Wash, USA). Data entry will be done by primary investigator using google forms and it will be stored with the primary investigator. Statistical analyses will be done using SPSS version 25 (IBM Corp., Armonk, NY, USA). Continuous measures will be expressed with sample size, mean (standard deviation), median (range), as and when required. Categorical measures will be presented as number of patients and percentage. The 95% confidence interval will be calculated using exact Clopper-Pearson for diagnostic yield and TER.

7. Ethical justification of the study This is a prospective nonrandomized non-controlled trial with patients not assigned to any specific intervention.

Eligibility criteria: Inclusion Criteria:

1. Patients with small bowel disease with an indication for Motorized spiral enteroscopy and age more than 10 years
2. Overt or obscure Gastrointestinal bleeding
3. Iron deficiency anaemia
4. Chronic diarrhoea
5. Abdominal pain for evaluation with suspected small bowel involvement.
6. IBD requiring small bowel evaluation
7. Polyposis syndrome requiring small bowel evaluation
8. Small bowel subacute obstruction
9. Refractory celiac disease

Exclusion Criteria:

1. Weight less than 30 kg
2. Large gastric or oesophageal varices
3. Any medical contraindication to standard enteroscopy
4. Any prior history of gastric , small bowel , large bowel surgery
5. Acute obstruction of small bowel
6. Suspected GI perforation
7. Any contraindication for general anaesthesia
8. Lack of informed consent.

Primary outcomes:
measure: Total enteroscopy rate with motorized spiral enteroscopy both via antegrade and the retrograde route.
timeFrame: 2 days
Secondary outcomes:
measure: Technical success of antegrade and the retrograde approach
timeFrame: 2 days
measure: Total procedural time
timeFrame: 2 days
measure: Depth of the maximal insertion
timeFrame: 2 days
measure: Diagnostic yield
timeFrame: 2 days
measure: Therapeutic yield
timeFrame: 2 days
measure: Adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Aniruddha Pratap Singh
state: Telangana
Study officials:
affiliation: AIG hospitals,India
name: Aniruddha P Singh, MBBS,MD,DM
role: PRINCIPAL_INVESTIGATOR
affiliation: AIG Hospitals,India
name: Mohan Ramchandani, MBBS,MD,DM
role: STUDY_DIRECTOR
affiliation: AIG Hospitals,India
name: Duvur Nageshwar Reddy
role: STUDY_CHAIR
References:
citation: Beyna T, Arvanitakis M, Schneider M, Gerges C, Hoellerich J, Deviere J, Neuhaus H. Total motorized spiral enteroscopy: first prospective clinical feasibility trial. Gastrointest Endosc. 2021 Jun;93(6):1362-1370. doi: 10.1016/j.gie.2020.10.028. Epub 2020 Nov 2.
citation: Beyna T, Arvanitakis M, Schneider M, Gerges C, Boing D, Deviere J, Neuhaus H. Motorised spiral enteroscopy: first prospective clinical feasibility study. Gut. 2021 Feb;70(2):261-267. doi: 10.1136/gutjnl-2019-319908. Epub 2020 Apr 24.
citation: Ramchandani M, Rughwani H, Inavolu P, Singh AP, Tevethia HV, Jagtap N, Sekaran A, Kanakagiri H, Darishetty S, Reddy DN. Diagnostic yield and therapeutic impact of novel motorized spiral enteroscopy in small-bowel disorders: a single-center, real-world experience from a tertiary care hospital (with video). Gastrointest Endosc. 2021 Mar;93(3):616-626. doi: 10.1016/j.gie.2020.07.001. Epub 2020 Jul 12.