Establishment of a National Surgical Tissue Biobank for Pediatric Crohn's Disease: An Implementation Feasibility Study.

BACKGROUND

Crohn's disease (CD) is a lifelong gastrointestinal inflammatory condition that often requires surgery, particularly for patients diagnosed in childhood. CD has been linked to a combination of microbial, genetic, and environmental factors, but pathogenesis remains unknown. We outline a framework for multicenter surgical biobanking across a large geographic area, required to enable meaningful research, and evaluate feasibility using the 2016 Consolidated Standards of Reporting Trials (CONSORT) extension to randomized pilot and feasibility trials. We also share proof-of-concept RNA sequencing and immunohistochemistry results demonstrating adequacy to generate high-quality translational results.

METHODS

CD patients (5-17.2 years) scheduled for intestinal resection were included. Intra-abdominal sepsis was excluded. Surgeons from 10 Canadian children's hospitals underwent virtual training on tissue collection. Bowel, mesenteric fat, and lymph nodes were collected intraoperatively, fixed in formalin and RNAlater, and shipped overnight to a single lab. Feasibility was determined by protocol adherence, study recruitment efficacy, and tissue viability.

RESULTS

Tissue has been collected from 18 patients at seven sites since the study launched in 2023. The biobank is on track to bank 30-50 % of the total estimated eligible yearly case volume. Adherence to shipping protocols was impacted by the day of the week of the operation and by shipping office closures. Proof-of-concept immunohistochemistry demonstrated high-quality multiplex images. RNA sequencing identified 560 genes discriminating between inflamed and non-inflamed bowel.

CONCLUSIONS

Establishing a national biobank for surgically resected pediatric CD is feasible for translational investigations of CD pathogenesis. Preliminary experiments demonstrate functional protocols sufficient to collect research-quality tissue.

LEVEL OF EVIDENCE: Prognosis Study - Level IV.