NCT03616548

Surveillance of Allograft Rejection After Intestinal Transplantation Using Endoscopy

Status unknown NA Last updated 6 August 2018

What this trial tests

NA trial testing Endoscopic surveillance in Rejection of an Intestine Transplant in 12 participants. Status unknown.

Timeline

14 November 2016

Primary endpoint
1 July 2020

1 July 2020

Quick facts

Lead sponsor	Far Eastern Memorial Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	12
Start date	14 November 2016
Primary completion	1 July 2020
Estimated completion	1 July 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• Endoscopic surveillance

Conditions studied

• Rejection of an Intestine Transplant — all drugs for Rejection of an Intestine Transplant →

Sponsor

Far Eastern Memorial Hospital

Who can join

7 and older, any sex, with Rejection of an Intestine Transplant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Surveillance of Rejection After Intestinal Transplantation Using an Image Enhanced Endoscopy "VENCH" Scoring System.
   Chung CS, Tsai CC, Chen KC, Lin CK, et al · · 2021 · cited 3× · PMID 33309060 · DOI 10.1016/j.transproceed.2020.10.002