Research at the Digestive Disease Institute
Digestive Disease Institute research focuses on identifying promising advances in the treatment of liver, inflammatory bowel, pancreas, stomach, bile duct, non-IBD colonic and esophageal disease. Our research portfolio includes translational, medical device and pharmaceutical trials as well as non-interventional research.
Selective Currently Enrolling Clinical Research Studies
To refer patients or to see a complete up-to-date list of the Digestive Disease Institute’s currently enrolling clinical trials, call the research hotline at (206) 341-1021 or visit our DDI Research page.
Goal: To assess whether rectal indomethacin alone is non-inferior to the combination of rectal indomethacin and prophylactic pancreatic stent placement for preventing post-ERCP pancreatitis in high-risk cases.
Goal: To determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum.
Goal: To evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced Delivery System in the management of symptoms of acute cholecystitis as an alternative to percutaneous gallbladder drainage.
Inflammatory Bowel Disease
Ulcerative Colitis: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy
Goal: Sub-Study 1: To evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.
Sub-Study 2: To evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Ulcerative Colitis: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis
Goal: To assess the efficacy of etrasimod on clinical remission in subjects with moderately to severely active ulcerative colitis after 12 and 52 weeks of treatment.
Goal: To evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active Crohn’s disease.
Goal: To evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.
Crohn’s Disease: A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks.
Goal: To evaluate the efficacy and safety of Cx601 compared to placebo for the treatment of complex perianal fistula(s) in patients with Crohn’s disease at Week 24 with a follow-up period up to 52 weeks.
Cancer: Biliary tract
Goal: To evaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants with cholangiocarcinoma with FGFR2 rearrangementt.
Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)
Goal: To evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma and complete radiological response after surgical resection or local ablation.
Goal: To assess the frequency of cytological conversion in patients with pancreatic adenocarcinoma and positive peritoneal cytology as a sole metastatic site following gemcitabine nab-paclitaxel.
Goal: To determine the organ preservation rate in patients with early (cT1-3 No) rectal cancer treated with neoadjuvant FOLFOX or CAPOX and TEMS or TAMIS.
Goal: To determine whether atezolizumab combined with FOLFOX and its continuation as monotherapy can significantly improve DFS compared to FOLFOX alone in patients with stage III colon cancers and dMMR.