Feasibility and Safety of Ttransendoscopic Enteral Tubing in Mid-gut

Not Applicable

• Conditions: Transendoscopic Enteral Tubing
• Interventions: Procedure: transendoscopic enteral tubing in mid-gut

• Registration Number: NCT03335982
• Lead Sponsor: The Second Hospital of Nanjing Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-08-01
• Status Verified: 2017-09
• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-11-04
• Study First Posted: 2017-11-08
• Last Update Submitted: 2017-11-29
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transendoscopic enteral tubing in mid-gut	transendoscopic enteral tubing in mid-gut	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.

Primary Outcome Measures

Name	Time	Method
success rate	All patients were followed up from date of intubation to one mouth after discharge	the success rate of of the TET procedure
adverse events rate	All patients were followed up from date of intubation to one mouth after discharge	Procedure-related and tube-related adverse events after procedure

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China