Colonic Transendoscopic Enteral TubingNCT03621033
Methods of Colonic Transendoscopic Enteral Tubing
A study testing colonic transendoscopic enteral tubing in people with Colonic Transendoscopic Enteral Tubing, run by The Second Hospital of Nanjing Medical University at 2 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Transendoscopic Enteral Tubing
- What is being tested?
- colonic transendoscopic enteral tubing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 2 sitesChina
- Study dates
- 10 Aug 2018to 10 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Data was not recorded as required; Before and after implantation is not the same physician operation.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Fmt-Dt-N-27/1350
Nanjing, Jiangsu, 210011
Faming Zhang, PhD,MD
Faming Zhang, MD,PhD
- Recruiting
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, MD, PhD, 086-25-58509883, fzhang@njmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Colonic Transendoscopic Enteral Tubing
- Being tested
- colonic transendoscopic enteral tubing
- Keywords
- transendoscopic enteral tubing, Microbiota Transplantation, transparent cap-assisted colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonic transendoscopic enteral tubingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| non-transparent cap-assisted endoscopic intubation | Other | we do not use transparent cap-assisted endoscopic intubation. Receives: Procedure: colonic transendoscopic enteral tubing |
| transparent cap-assisted endoscopic intubation | Other | we use transparent cap-assisted endoscopic intubation in the second insertion. Receives: Procedure: colonic transendoscopic enteral tubing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The second cecal intubation time
Record the time of colonoscopy from the anus to the ileal flap in the second insertion.
Measured: one day
Secondary outcomes (6)
Adverse events rate
Procedure-related and tube-related adverse events after procedure
Measured: 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
Measured: 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.
Measured: one day
Retention time of tube
Retention time of colonic transendoscopic enteral tubing
Measured: three month
Tubing time
The tubing time is from advancement of the TET tube through the channel to the end of the tubing.
Measured: one day
Titanium clip fixation time
Record the time required for fixing a titanium clip.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start10 Aug 2018
- Primary completion10 May 2020 (estimated)
- Study completion10 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic Transendoscopic Enteral TubingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, MD; PhD, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621033
- Sponsor's protocol ID
- TET-CN-170803
- Status last verified
- Feb 2020
- First submitted
- 5 Aug 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 27556065Westwood 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.
PubMed 22228167
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methods of Colonic Transendoscopic Enteral Tubing: a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03621033
- Acronym / sponsor ID
- TET-CN-170803
- Conditions
- Colonic Transendoscopic Enteral Tubing
- Keywords
- transendoscopic enteral tubing, Microbiota Transplantation, transparent cap-assisted colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 10 May 2020 (estimated)
- Study completion
- 10 May 2020 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-transparent cap-assisted endoscopic intubation | Other | Procedure: colonic transendoscopic enteral tubingwe do not use transparent cap-assisted endoscopic intubation. |
| transparent cap-assisted endoscopic intubation | Other | Procedure: colonic transendoscopic enteral tubingwe use transparent cap-assisted endoscopic intubation in the second insertion. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Data was not recorded as required; Before and after implantation is not the same physician operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonic transendoscopic enteral tubingThe 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. | Procedure or surgery | non-transparent cap-assisted endoscopic intubation, transparent cap-assisted endoscopic intubation |
Primary outcome
The second cecal intubation time
Time frame: one day
Record the time of colonoscopy from the anus to the ileal flap in the second insertion.
6 secondary outcomes
Adverse events rate
Time frame: All patients were followed up from date of intubation to one mouth after discharge
TET success rate
Time frame: one day
Maximum insertion pain score
Time frame: one day
Retention time of tube
Time frame: three month
Tubing time
Time frame: one day
Titanium clip fixation time
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Results publication: PubMed 27556065Peng 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.
- Results publication: PubMed 22228167Westwood 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faming Zhang, MD; PhD study chair
Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonic transendoscopic enteral tubing in people with Colonic Transendoscopic Enteral Tubing, run by The Second Hospital of Nanjing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faming Zhang, MD; PhD (086-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The second cecal intubation time (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621033, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.