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Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET (RIT;TET)

Primary Purpose

Fecal Microbiota Transplantation, Bowel Obstruction

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
retrograde image by colonic TET
Sponsored by
The Second Hospital of Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fecal Microbiota Transplantation focused on measuring Washed Microbiota Transplantation, Fecal Microbiota Transplantation, Transendoscopic enteral tubing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptoms of intestinal obstruction such as abdominal pain, abdominal distension, nausea, vomiting, cessation of anal exhaust and defecation;
  • Abdominal X-ray or plain CT showed signs of intestinal obstruction;
  • Participants suspected with intestinal stricture according to the recent lower GI endoscopy;
  • Voluntarily sign written informed consent.

Exclusion Criteria:

  • Signs of peritonitis, perforation or massive hemorrhage of digestive tract;
  • Accompanied with severe heart, brain, lung and kidney dysfunction, unable to take lower GI endoscopy;
  • Allergic to laxatives or iodine contrast agents;
  • Pregnant women;
  • Confirmed or suspected claustrophobia;
  • Inability to understand or provide informed consent

Sites / Locations

  • Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

retrograde imaging by colonic TET

Arm Description

Contrast fluid will be injected through colonic TET in participants with bowel obstruction. Image parameters detected by CT and X-ray fluoroscopy will be evaluated.

Outcomes

Primary Outcome Measures

The diagnostic self-confidence score
Image parameters of the lesion( i e. Location,Nature, Severity, Appearance, Fistula) will be recorded by the reader. The diagnostic self-confidence for each image parameter will be determined using a continuous five-grade scoring system from 1 to 5(1 = worst, 2=worsen, 3=normal, 4= better,5 = best). For example: The doctor's diagnostic self-confidence for Location is worsen ,then the diagnostic self-confidence score will be recorded as 2。
Evaluation of comprehensive diagnostic efficiency
comprehensive diagnostic efficiency=(Location+Nature+Appearance+Fistula+Proximal lesion filled by contrast fluid). Each positive parameter will be recorded as mark 1, negative mark 0. Each participant will get up to 5 score. For example: for some one participant ,if the doctor could determine the location and nature of the lesion, however,appearance, fistula and proximal lesion filled by contrast fluid could not be determined, then ,the score of comprehensive diagnostic efficiency equals 2.

Secondary Outcome Measures

Adverse reaction
Adverse reaction( abdominal pain, abdominal distention, nausea, vomiting) will be recorded and graded by score 1 to 5 according to the severity of each symptom.
Tolerance
Tolerance will be evaluated by questionnaire investigation。1--Severely intolerable;2--Moderately intolerable;3--Slightly intolerable;4--Tolerable。

Full Information

First Posted
February 7, 2022
Last Updated
February 15, 2022
Sponsor
The Second Hospital of Nanjing Medical University
Collaborators
SIR RUN RUN hospital of Nanjing Medical University, Wuxi No. 2 People's Hospital, The First Affiliated Hospital of Guangdong Pharmaceutical University
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1. Study Identification

Unique Protocol Identification Number
NCT05253222
Brief Title
Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET
Acronym
RIT;TET
Official Title
Methodology and Clinical Value of Retrograde Imaging Technique in Intestinal Obstructive Diseases Mediated by Colonic Transendoscopic Enteral Tubing
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Nanjing Medical University
Collaborators
SIR RUN RUN hospital of Nanjing Medical University, Wuxi No. 2 People's Hospital, The First Affiliated Hospital of Guangdong Pharmaceutical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The etiology of bowel obstruction is usually diagnosed by imaging techniques such as MSCTE,MRE, et al, which have some disadvantages. For example, in order to obtain better image quality, MSCTE(Multi-slices spiral computed tomography enterography) and MRE( Magnetic resonance enterography)require patients to take a large amount of intestinal contrast solution orally, while for patients with intestinal obstruction, which may further aggravate the disease. Our study team had confirmed the mid-gut TET could serve as the delivery way of contrast solution for MRE bowel preparation with better accuracy of lesion detection and lower reduction of pain in CD(Crohn's Disease) patients. In this study, contrast solution will be delivered by colonic TET placed by lower GI-endoscopy, then we will evaluate the methodology and clinical value of this kind retrograde imaging technique in patients with intestinal obstructive diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Microbiota Transplantation, Bowel Obstruction
Keywords
Washed Microbiota Transplantation, Fecal Microbiota Transplantation, Transendoscopic enteral tubing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
retrograde imaging by colonic TET
Arm Type
Experimental
Arm Description
Contrast fluid will be injected through colonic TET in participants with bowel obstruction. Image parameters detected by CT and X-ray fluoroscopy will be evaluated.
Intervention Type
Diagnostic Test
Intervention Name(s)
retrograde image by colonic TET
Intervention Description
Delivery of contrast fluid by colonic TET Each participant will receive one delivery of 200 ml contrast fluid by colonic TET to the distal portion of the lesion. One group will be taken CT investigation, another group will be taken X-ray fluoroscopy. Imaging parameters will be collected and evaluated.
Primary Outcome Measure Information:
Title
The diagnostic self-confidence score
Description
Image parameters of the lesion( i e. Location,Nature, Severity, Appearance, Fistula) will be recorded by the reader. The diagnostic self-confidence for each image parameter will be determined using a continuous five-grade scoring system from 1 to 5(1 = worst, 2=worsen, 3=normal, 4= better,5 = best). For example: The doctor's diagnostic self-confidence for Location is worsen ,then the diagnostic self-confidence score will be recorded as 2。
Time Frame
immediately after CT/X-ray fluoroscopy detection,no more than 24hours.
Title
Evaluation of comprehensive diagnostic efficiency
Description
comprehensive diagnostic efficiency=(Location+Nature+Appearance+Fistula+Proximal lesion filled by contrast fluid). Each positive parameter will be recorded as mark 1, negative mark 0. Each participant will get up to 5 score. For example: for some one participant ,if the doctor could determine the location and nature of the lesion, however,appearance, fistula and proximal lesion filled by contrast fluid could not be determined, then ,the score of comprehensive diagnostic efficiency equals 2.
Time Frame
immediately after CT/X-ray fluoroscopy detection,no more than 24hours.
Secondary Outcome Measure Information:
Title
Adverse reaction
Description
Adverse reaction( abdominal pain, abdominal distention, nausea, vomiting) will be recorded and graded by score 1 to 5 according to the severity of each symptom.
Time Frame
during the process, and no more than 24hours after CT/X-ray fluoroscopy detection
Title
Tolerance
Description
Tolerance will be evaluated by questionnaire investigation。1--Severely intolerable;2--Moderately intolerable;3--Slightly intolerable;4--Tolerable。
Time Frame
during the process, and no more than 24hours after CT/X-ray fluoroscopy detection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms of intestinal obstruction such as abdominal pain, abdominal distension, nausea, vomiting, cessation of anal exhaust and defecation; Abdominal X-ray or plain CT showed signs of intestinal obstruction; Participants suspected with intestinal stricture according to the recent lower GI endoscopy; Voluntarily sign written informed consent. Exclusion Criteria: Signs of peritonitis, perforation or massive hemorrhage of digestive tract; Accompanied with severe heart, brain, lung and kidney dysfunction, unable to take lower GI endoscopy; Allergic to laxatives or iodine contrast agents; Pregnant women; Confirmed or suspected claustrophobia; Inability to understand or provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faming Zhang, MD,PhD
Phone
+8615005160383
Email
fzhang@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faming Zhang, MD, PhD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faming Zhang, MD, PhD
Phone
+86-025-58509883
Email
fzhang@njmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28439845
Citation
Rami Reddy SR, Cappell MS. A Systematic Review of the Clinical Presentation, Diagnosis, and Treatment of Small Bowel Obstruction. Curr Gastroenterol Rep. 2017 Jun;19(6):28. doi: 10.1007/s11894-017-0566-9.
Results Reference
background
PubMed Identifier
31168315
Citation
Catena F, De Simone B, Coccolini F, Di Saverio S, Sartelli M, Ansaloni L. Bowel obstruction: a narrative review for all physicians. World J Emerg Surg. 2019 Apr 29;14:20. doi: 10.1186/s13017-019-0240-7. eCollection 2019.
Results Reference
background
PubMed Identifier
30119766
Citation
Sheedy SP, Kolbe AB, Fletcher JG, Fidler JL. Computed Tomography Enterography. Radiol Clin North Am. 2018 Sep;56(5):649-670. doi: 10.1016/j.rcl.2018.04.002. Epub 2018 Jul 11.
Results Reference
background
PubMed Identifier
23011551
Citation
Masselli G, Gualdi G. CT and MR enterography in evaluating small bowel diseases: when to use which modality? Abdom Imaging. 2013 Apr;38(2):249-59. doi: 10.1007/s00261-012-9961-8.
Results Reference
background
PubMed Identifier
27556065
Citation
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.
Results Reference
background
PubMed Identifier
30606236
Citation
Dai M, Zhang T, Li Q, Cui B, Xiang L, Ding X, Rong R, Bai J, Zhu J, Zhang F. The bowel preparation for magnetic resonance enterography in patients with Crohn's disease: study protocol for a randomized controlled trial. Trials. 2019 Jan 3;20(1):1. doi: 10.1186/s13063-018-3101-x.
Results Reference
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Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET

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