Research at the Digestive Disease Institute

Research Team.
The Digestive Disease Institute’s robust clinical trials team. Team Members include (clockwise from top left) Katrina Magbitang, Anh Hau, Cheryl Shaw, Vy Trinh, Sarah Ackermann, Audrey Merz, Katie Gelinas and Kate Beck.

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.

Therapeutic Endoscopy

Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI Trial

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.

SHARP Trial: SpHincterotomy for Acute Recurrent Pancreatitis Trial

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.

A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients with Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage

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.

Crohn’s Disease: A Study of the Efficacy and Safety of Risankizumab 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 Crohn’s disease.

Crohn’s Disease: A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

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

A Study of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement.

Goal: To evaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants with cholangiocarcinoma with FGFR2 rearrangementt.

Cancer: Liver

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.

Cancer: Pancreas

Gemcitabine and Nab-Paclitaxel in Pancreatic Adenocarcinoma with Positive Peritoneal Cytology as a Sole Metastatic Site, a Pilot Study

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.

Cancer: Rectal

Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer: The Neo Trial

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.

Cancer: Colon

Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair

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.