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Feasibility and Safety of Ttransendoscopic Enteral Tubing in Mid-gut

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335982
Recruitment Status : Unknown
Verified September 2017 by Faming Zhang, The Second Hospital of Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : November 8, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Study Description
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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 .

Condition or disease Intervention/treatment Phase
Transendoscopic Enteral Tubing Procedure: transendoscopic enteral tubing in mid-gut Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Safety of Ttransendoscopic Enteral Tubing in Mid-gut
Actual Study Start Date : August 1, 2015
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 1, 2017
Arms and Interventions
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Arm Intervention/treatment
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.
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335982


Contacts
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Contact: Faming Zhang, MD; PhD 086-25-58509883 fzhang@njmu.edu.cn

Locations
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China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Faming Zhang, MD, PhD    086-25-58509883    fzhang@njmu.edu.cn   
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
More Information
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Publications:

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Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03335982    
Other Study ID Numbers: TET-CN-151001
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
transendoscopic enteral tubing
mid-gut
endoscopy
 nasal-jejunal tube
fecal microbiota transplantation
enteral nutrition