Surveillance of Allograft Rejection After Intestinal Transplantation Using Endoscopy

NCT03616548 | Unknown DMC

• 1 other identifier: FEMH-105023-F
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Intestinal failure (IF) which are characterized by inadequate maintenance of nutrition via normal intestinal function comprises a group of disorders with many different causes. If IF persists for more than a few days, it demands treatment with the intravenous supplement of water and nutrients, so-called parenteral nutrition (PN), to avoid life-threatening complications. However, PN dependency is associated with higher mortality and is therefore considered to have indications for intestine transplantation (IT). Graft acute cellular rejection is one of the most important reasons for graft failure. As a result, early identification of ACR and timely modification of anti-rejection medications has been considered to be associated with better graft and patient survivals. The diagnostic gold standard for ACR is mainly based on histology, but hours of delay by pathology may occur. Additionally, immunity in small bowel after transplantation should rely on a balance of innate and adaptive immune responses in the presence of the gut microbiota which the distribution may change after IT. Few researches investigated the association of changes of gut microbiota with graft rejection and narrow-band imaging endoscopy which can provide timely diagnosis of ACR in IT patients. In this study, we aimed to investigate the association of changes in mucosa-associated microbiota which was not addressed in the literature with rejection reaction by next-generation sequencing methods. We also use a new endoscopic scoring system to evaluate the diagnostic accuracy of rejection reaction using pathology as standard reference.

Conditions

Rejection of an Intestine Transplant

Keywords

intestinal transplantation; graft rejection; image enhanced endoscopy; narrow band imaging

Outcome Measures

Primary Outcomes (1)

• Correlation of endoscopic scoring system with severity of histological rejection

  Endoscopists who are blinded to the clinical data recorded the imaging findings based on the V-E-N-C-H score, and the pathologists who are blinded to the clinical data reported the endoscopic biopsy specimen findings about rejection. Pearson's correlation test is used to evaluate the correlation between endoscopic and pathological findings.

  1 year

Study Arms (1)

Intestinal transplantation

OTHER

Magnifying endoscopy under NBI system via chimney ileostomy after intestinal transplantation using a novel VENCH scoring system

Diagnostic Test: Endoscopic surveillance

Interventions

Endoscopic surveillance DIAGNOSTIC_TEST

Magnifying endoscopy under narrow band imaging system via chimney ileostomy after intestinal transplantation

Intestinal transplantation

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-small intestinal transplantation patients
• Older than 7-year-old
• With informed consent for endoscopy and biopsy

You may not qualify if:

• Bleeding tendency (platelet count \<80k/ul, PTINR \>1.5)
• Without informed consent for endoscopy and biopsy
• Leukopenia (ANC \<1,500/ul)

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan

RECRUITING

Related Publications (1)

• Chung CS, Tsai CC, Chen KC, Lin CK, Lee TH, Tsai HW, Chen Y. Surveillance of Rejection After Intestinal Transplantation Using an Image Enhanced Endoscopy "VENCH" Scoring System. Transplant Proc. 2021 Jan-Feb;53(1):364-370. doi: 10.1016/j.transproceed.2020.10.002. Epub 2020 Dec 9.

  PMID: 33309060 DERIVED

Study Officials

• Chen Shuan Chung, MD, MSc

  Department of Internal Medicine, Far Eastern Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Chen Shuan Chung, MD,MSc

CONTACT

886-910667236; chungchenshuan_3@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 6, 2018
• Study Start: November 14, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)