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Clinical Trials/NCT03335982
NCT03335982
Unknown
Not Applicable

Feasibility and Safety of Ttransendoscopic Enteral Tubing in Mid-gut

The Second Hospital of Nanjing Medical University1 site in 1 country100 target enrollmentAugust 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transendoscopic Enteral Tubing
Sponsor
The Second Hospital of Nanjing Medical University
Enrollment
100
Locations
1
Primary Endpoint
success rate
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2015
End Date
December 1, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
The Second Hospital of Nanjing Medical University
Responsible Party
Principal Investigator
Principal Investigator

Faming Zhang

Associate professor, Gastroenterology

The Second Hospital of Nanjing Medical University

Eligibility Criteria

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

Outcomes

Primary Outcomes

success rate

Time Frame: 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

Time Frame: All patients were followed up from date of intubation to one mouth after discharge

Procedure-related and tube-related adverse events after procedure

Study Sites (1)

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