Methods of Colonic Transendoscopic Enteral Tubing

Methods of Colonic Transendoscopic Enteral Tubing: a Multicenter, Randomized Controlled Trial

Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. The aim of this study was to evaluate the methodology, efficiency, feasibility and safety of using transparent cap-assisted endoscopy for colon TET implantation.

Study Overview

• Status: Unknown
• Conditions: Colonic Transendoscopic Enteral Tubing
• Intervention / Treatment: Procedure: colonic transendoscopic enteral tubing

Detailed Description

Our previous article has reported the method of colon TET. However, the investigators found that it was difficult to find the cavity because of the concentration of intestinal folds caused by the tube pulling after insertion of TET. It is well known that transparent cap-assisted colonoscopy is easier to flatten the semilunar folds and improve mucosal exposure. Here the investigators test the hypothesis that using transparent cap-assisted colonoscopy significantly decreases the second cecal intubation time which not only improve work efficiency, but also saves patients' anesthesia time and cost. Thus, the investigators design a prospective multicenter, randomized controlled trial. The aim of this study was to evaluate the methodology, efficiency, feasibility and safety of using transparent cap-assisted endoscopy for colon TET implantation.

• Study Type: Interventional
• Enrollment (Anticipated): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • Fmt-Dt-N-27/1350
      • Contact: Faming Zhang, PhD,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diseases requiring total colonic administration and fecal microbiota transplantation.
• Patients and healthy Volunteers with the need to sample in deep colon .
• Age > 7 years.
• Must be able to Colonic Transendoscopic Enteral Tubing and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation.

Exclusion Criteria:

• Data was not recorded as required; Before and after implantation is not the same physician operation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: non-transparent cap-assisted endoscopic intubation; we do not use transparent cap-assisted endoscopic intubation.	Procedure: colonic transendoscopic enteral tubing; The procedure colonic transendoscopic enteral tubing is as follows:The TET tube was inserted into the ileocecal junction through the endoscopy channel at the first time of the cecal intubation after examination and evaluation of the whole colon. Then, the colonoscope was removed from the colon while the TET tube was maintained at the ileocecal junction. Then the endoscopy was inserted into the ileocecum again for affixing the TET tube to cecum with titanium clips.
OTHER: transparent cap-assisted endoscopic intubation; we use transparent cap-assisted endoscopic intubation in the second insertion.	Procedure: colonic transendoscopic enteral tubing; The procedure colonic transendoscopic enteral tubing is as follows:The TET tube was inserted into the ileocecal junction through the endoscopy channel at the first time of the cecal intubation after examination and evaluation of the whole colon. Then, the colonoscope was removed from the colon while the TET tube was maintained at the ileocecal junction. Then the endoscopy was inserted into the ileocecum again for affixing the TET tube to cecum with titanium clips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The second cecal intubation time	Record the time of colonoscopy from the anus to the ileal flap in the second insertion.	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
TET success rate	The success rate of of the TET procedure	one day
Maximum insertion pain score	Using numerical rating scale to evaluate maximum insertion pain score in non anesthesia. The digital grading method uses 0-10 to represent different levels of pain, with 0 as painless and 10 as severe. The classification standard of pain degree is: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.	one day
Retention time of tube	Retention time of colonic transendoscopic enteral tubing	three month
Tubing time	The tubing time is from advancement of the TET tube through the channel to the end of the tubing.	one day
Titanium clip fixation time	Record the time required for fixing a titanium clip.	one day

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University
• Investigators: Study Chair: Faming Zhang, MD; PHD, Nanjing Medical University

Publications and helpful links

General Publications

• Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.
• Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum. 2012 Feb;55(2):218-25. doi: 10.1097/DCR.0b013e31823461ef.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2018
• Primary Completion (ANTICIPATED): May 10, 2020
• Study Completion (ANTICIPATED): May 10, 2020

Study Registration Dates

• First Submitted: August 5, 2018
• First Submitted That Met QC Criteria: August 5, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 22, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: transendoscopic enteral tubing; Microbiota Transplantation; transparent cap-assisted colonoscopy
• Other Study ID Numbers: TET-CN-170803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No