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

Fecal Microbiota Transplantation Clinical Trial

— RIT;TET  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05253222
• Other study ID #: TET2022N001
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: February 2022
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang, MD,PhD
• Phone: +8615005160383
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Obstruction
• Fecal Microbiota Transplantation
• Intestinal Obstruction

Intervention

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.

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University	SIR RUN RUN hospital of Nanjing Medical University, The First Affiliated Hospital of Guangdong Pharmaceutical University, Wuxi No. 2 People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Review. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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