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

Study Overview
=================
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.

Official Title
-----------------
Methodology and Clinical Value of Retrograde Imaging Technique in Intestinal Obstructive Diseases Mediated by Colonic Transendoscopic Enteral Tubing

Conditions
-----------------
Fecal Microbiota Transplantation, Bowel Obstruction

Intervention / Treatment
-----------------
* Diagnostic Test: retrograde image by colonic TET


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: retrograde imaging by colonic TET<br>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. | Diagnostic Test: retrograde image by colonic TET<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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。 | immediately after CT/X-ray fluoroscopy detection，no more than 24hours. | 
| 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. | immediately after CT/X-ray fluoroscopy detection，no more than 24hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during the process, and no more than 24hours after CT/X-ray fluoroscopy detection | 
| Tolerance | Tolerance will be evaluated by questionnaire investigation。1--Severely intolerable；2--Moderately intolerable；3--Slightly intolerable；4--Tolerable。 | during the process, and no more than 24hours after CT/X-ray fluoroscopy detection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Washed Microbiota Transplantation, Fecal Microbiota Transplantation, Transendoscopic enteral tubing