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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05253222

Acronym

RIT;TET

Enrollment

Registered

2022-02-23

Start date

2022-03-01

Completion date

2023-06-01

Last updated

2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Obstruction, Fecal Microbiota Transplantation

Keywords

Washed Microbiota Transplantation, Fecal Microbiota Transplantation, Transendoscopic enteral tubing

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.

Interventions

DIAGNOSTIC_TESTretrograde image by colonic TET

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
The diagnostic self-confidence score	immediately after CT/X-ray fluoroscopy detection，no more than 24hours.	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	immediately after CT/X-ray fluoroscopy detection，no more than 24hours.	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

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

Countries

China

Contacts

Primary ContactFaming Zhang, MD,PhD

fzhang@njmu.edu.cn+8615005160383

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026