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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bowel Obstruction; Fecal Microbiota Transplantation
• Intervention / Treatment: Diagnostic test: retrograde image by colonic TET

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Faming Zhang, MD,PhD; Phone Number: +8615005160383; Email: fzhang@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University
      • Contact: Faming Zhang, MD, PhD; Phone Number: +86-025-58509883; Email: fzhang@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: retrograde imaging by colonic TET; 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; 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.

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

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University
• Collaborators: The First Affiliated Hospital of Guangdong Pharmaceutical University; Wuxi No. 2 People's Hospital; SIR RUN RUN hospital of Nanjing Medical University
• Investigators: Study Chair: Faming Zhang, MD, PhD, Nanjing Medical University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation; Washed Microbiota Transplantation; Transendoscopic enteral tubing
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: TET2022N001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No