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

Not Applicable

• Conditions: Fecal Microbiota Transplantation; Bowel Obstruction

• Registration Number: NCT05253222
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-15
• Last Update Submitted: 2022-02-15
• Study First Posted: 2022-02-23
• Last Update Posted: 2022-02-23
• Study Start: 2022-03-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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。
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.

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China