Feasibility and Safety of Ttransendoscopic Enteral Tubing in Mid-gut

Study Overview
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Brief Summary
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A transendoscopic enteral tubing (TET ) tube was inserted into mid-gut through the nasal orifice and fixed on the pylorus wall by one tiny titanium endoscopic clip under anesthesia. This study aimed to evaluate the feasibility and safety of TET in mid-gut .

Detailed Description
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In recent years, fecal microbiota transplantation (FMT) has gained appeal as a therapeutic option worldwide. Traditionally, microbiota can be administered through the upper-gut, the mid-gut, and the lower-gut pathways. FMT via colonoscopy is a classic approach, but in our previous study on ulcerative colitis, those patients have difficulty to maintain the infused microbiota suspension for enough time through this way. Thus, the investigators designed the colonic transendoscopic enteral tubing (TET) technology, which made whole-colon administration of treatment and repeat FMTs possible. However, some patients are resistant to undergo bowel preparation for colonoscopy or some are not suitable for colonic delivering way. Therefore, mid-gut delivering way is an important option for those patients. In previous researches on FMT for Crohn's disease, patients and physician faced the similar problem that some patients need repeat FMT during hospitalization, and some may need enteral nutrition at the same time. In order to have a quicker and more convenient placement of mid-gut/nasal-jejunal TET tube than traditional methods, the investigators designed a novel mid-gut TET technique without further confirmation for the location of tube in gut by X-ray or other medical devices after the endoscopic procedure. This study aimed to evaluate the feasibility, safety, and value of the mid-gut TET technique.

Official Title
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Feasibility and Safety of Ttransendoscopic Enteral Tubing in Mid-gut

Conditions
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Transendoscopic Enteral Tubing

Intervention / Treatment
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* Procedure: transendoscopic enteral tubing in mid-gut


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate inflammatory bowel disease (Montreal classification) or suitability for endoscopy, and consented to undergo TET placement for their diseases and conditions Exclusion Criteria: No history of using Biologic, immunomodulatory therapy or corticosteroid therapy. With contraindication of endoscopy. Pregnant or lactating female

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: transendoscopic enteral tubing in mid-gut<br>A TET tube was inserted into mid-gut through the nasal orifice and fixed on the pylorus wall by one tiny titanium endoscopic clip under anesthesia. The feasibility, safety, success rate, and satisfaction with TET placement were evaluated for enteral nutrition or fecal microbiota transplantation. | Procedure: transendoscopic enteral tubing in mid-gut<br>* A TET tube was inserted into mid-gut through the nasal orifice and fixed on the pylorus wall by one tiny titanium endoscopic clip under anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | the success rate of of the TET procedure | All patients were followed up from date of intubation to one mouth after discharge | 
| adverse events rate | Procedure-related and tube-related adverse events after procedure | All patients were followed up from date of intubation to one mouth after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transendoscopic enteral tubing, mid-gut, endoscopy, nasal-jejunal tube, fecal microbiota transplantation, enteral nutrition