Research projects chosen as “best in category” and praised for representing excellence in clinical research were presented at the Presidential Plenary sessions at the American College of Gastroenterology (ACG) 2020 Clinical Meeting.

Plenary Session 1, hosted by outgoing ACG president Mark Pochapin, MD, FACG, and Brooks D. Cash, MD, FACG, chair of the ACG Educational Affairs Committee, featured 6 research presentations.

New-Onset Diabetes as Biomarker of Pancreatic Malignancy

Adam Schweber, BA, a medical student at Columbia University, gave the oral presentation of a research project titled “Using Large Sample Real-World Data to Study the Progression of Low-Risk Pancreatic Cysts: New Onset Diabetes as a Potential Biomarker of Malignant Transformation.” Research shows new-onset diabetes is a risk factor for pancreatic cancer in the general population but studies have been limited by small sizes.

Schweber and his colleagues reviewed data from approximately 14,000 patients, identifying those found to have a putatively low-risk pancreatic cyst and following their course. Patients with low-risk cysts who were diagnosed with new-onset diabetes mellitus progressed to pancreatic cancer at 3 times the rate of patients with cysts but without DM. Patients with a prior history of diabetes mellitus (DM) progressed at twice the rate of patients without a history of the disease.

“Real-world data with large sample sizes has become a powerful tool to study the natural history of disease and risk factors,” Schweber concluded.

Treating Immune-Mediated Diarrhea and Colitis in Patients with Cancer

In “Comparative study of vedolizumab and infliximab treatment in patients with immune-mediated diarrhea and colitis, the research team from the MD Anderson Cancer Center was represented by Yinghong Wang, MD. Her team compared agents and dosages to determine both outcomes among patients with cancer being treated with immunotherapy who also developed colitis and diarrhea. They enrolled 150 adult cancer patients seen at the center from June 2016 through March 2020 who received immunotherapy; 71 (47%) received infliximab alone; 61 (41%) received vedolizumab alone; and 18 (12%) received both. Of these patients, 82% were in stage IV and were treated with checkpoint inhibitors cytotoxic T-lymphocyte-associated protein 4 (18%), programmed death-ligand 1 (49%), or a combination (33%). The median treatment period for colitis was 70 days, with a follow-up duration of 12 months.

Patients who received vedolizumab required fewer days of treatment with steroids and fewer steroid tapering attempts. They required fewer infusions than patients receiving infliximab and had shorter hospital stays (10.5 days) when inpatient treatment was required than patients treated with infliximab (14 days). They also had fewer recurrences of colitis (13%) than patients treated with infliximab (28%). However, from first dose to remission of symptoms took 17 days for vedoluzimab and 10 days for infliximab; infliximab had longer hospital stays (14 days) vs 10.5 for vedolizumab. The rates of clinical remission were virtually identical—89% for vedolizumab and 87% for infliximab.

Dr Wong noted that vedolizumab was also associated with superior overall survival in the patients being treated for cancer, and that higher doses were also associated with better survival.

“It appears that vedolizumab and infliximab are equally efficacious in managing colitis and immune-mediated diarrhea in patients with cancer. However, vedolizumab is much safer for long-term use in patients with cancer,” she explained.

Statins Appear to Reduce Colorectal Cancer Risk

The effect of a widely prescribed medication on cancer was also the subject of a presentation by Kevin Singh, MD, from NYU-Langone Health, “Statins Reduce Risk of Colorectal Cancer”. Dr Singh and colleagues conducted a comprehensive literature search and meta-analysis to determine whether statins, one of the most frequently prescribed and well-tolerated medications that have also been linked to reductions in other types of cancer, might show a similar effect on colorectal cancer (CRC) in patients with inflammatory bowel disease (IBD). Their meta-analysis of 52 studies that included 11 million patients with IBD, including 2 million who used statins, found statin use was associated with a 20% risk reduction among patients without IBD. A separate analysis of 5 observational studies including 17,000 patients with IBD found that the 2000 patients who took statins had a 60% lower risk of CRC than the 15,000 patients with IBD who did not take statins.

Dr Singh noted that there was significant heterogeneity in both studies and stated that “randomized clinical trials are needed to confirm the risk reduction for CRC in patients with IBD, and whether there is any difference in the effect of statins on patients with ulcerative colitis and Crohn disease.” This presentation received the ACG Governors Award for Excellence in Clinical Research (Fellow-in-Training.)  

Comparing Endoscopic Resection to Esophagectomy for EAC Treatment 

Researchers from Brooklyn Hospital in New York were represented by Daryl Ramai, MD, in presenting their study of “Endoscopic Resection of T1b Esophageal Adenocarcinoma Compared to Esophagectomy.” Noting that esophagectomy has been standard treatment for early-stage esophageal adenocarcinoma (EAC), he explained that the procedure is associated with high risks of morbidity and mortality. Prior studies have examined the efficacy of endoscopic resection in T1A EAC lesions; Ramai and colleagues set out to determine if T1b EAC can be effectively treated with endoscopic therapy. In a retrospective study they reviewed the outcomes of 603 patients diagnosed with T1b EAC. Of these patients, 61% underwent surgical resection, while 16% were treated via endoscopic resection. The study revealed that there was no statistically significant difference in mortality between the two groups. At 1 year, both showed 91% survival; at 5 years, 69% of patients who had surgical resection survived, compared with 77% of the patients who had endoscopic resection, according to Kapler-Meier estimation. Cox regression models also indicated no significant different in risk ratios.

“Endoscopy remains underutilized in the treatment of EAC,” Ramai said. “It is cost-effective and should be considered a primary therapy for T1b EAC.” This presentation was named recipient of the Lawlor Resident Award.

Kiwifruit Rates High in Patient Satisfaction For Constipation Treatment

In a study of food-based remedies to gastrointestinal conditions named the Category Award winner for Functional Bowel Disease, Samuel Chey, MPH, from the University of Michigan, discussed his research team’s study, “Randomized comparative effectiveness trial of green kiwifruit, psyllium, and prunes for chronic constipation in US Patients.” Observing that psyllium and prunes are evidence-based treatments for this condition, Chey noted that kiwifruit has not been evaluated in North America as a potential treatment. He and his colleagues recruited patients from the University of Michigan’s gastroenterology clinic, 37% of whom had been diagnosed with irritable bowel syndrome-constipation (IBS-C). These patients were grouped into 3 cohorts that ingested 6 g fiber daily from either 2 peeled green kiwifruit, 12 prunes, or 12 grams of psyllium. The primary outcomes were an increase of 1 or more spontaneous bowel movements daily, along with secondary measures of mean daily stool frequency, straining, and patient satisfaction. The prune group demonstrated the largest magnitude of response (67%), but there was no significant difference between the treatment groups. The kiwifruit group evidenced the highest rate of patient satisfaction (68%) while the groups ingesting prunes and psyllium showed satisfaction of 48%.

“The kiwifruit group had the lowest rates of adverse events, including gas and bloating,” Chey said. “We think this may be attributable to the low FODMAP content in kiwifruit.”

Using VCE to Reduce Exposure to COVID-19 

The potential for exposure to the SARS-CoV-2 virus during endoscopy created significant concerns among patients and practitioners alike, exacerbated in many areas by a shortage of personal protective equipment (PPE). Shahrad Hakimian, MD, a gastroenterology fellow at the University of Massachusetts, and colleagues examined the use of video capsule endoscopy (VCE) as a way to allay both concerns. In his presentation of “Video Capsule Endoscopy as First Procedure for Acute GI Bleeding: Approach to Minimizing Exposure to COVID and Preserving Resources,” Dr Hakimian said that the team began with the hypothesis that the use of VCE as the first diagnostic modality for identifying sources of gastrointestinal (GI) bleeding can reduce the number of invasive procedures required for diagnosis and limit the use of resources, including PPE, during the pandemic. In a cohort study with historical controls, the researchers compared 50 hemodynamically stable patients with suspected GI bleeding and severe anemia who presented from mid-March to mid-May 2020, who underwent VCE as a first-line procedure (the COVID arm) vs 57 patients who received standard of care for GI bleeding in January 2020 (the pre-COVID arm). The groups had similar baseline characteristics. In the standard-of-care group, only 5% had VCE, while 100% of the COVID arm received VCE as first-line therapy.

The primary outcome was localization bleeding. In the COVID arm, VCE localized the site of bleeding in 76% of patients. In the pre-COVID arm, bleeding was localized by standard of care in 63% of historical controls. This did not reach statistical significance.

“What was more important is that active bleeding or stigmata of bleeding could be identified in 66% of the COVID group vs 28% of pre-COVID group,” Dr Hakimian said. “In the COVID arm, only 44% of patients need an invasive procedure vs 96% of the pre-COVID group. Our conclusion is that VCE is a safe alternative to standard of care as a first-line approach to identifying GI bleeding.” This presentation was named the Fellows-in-Training award winner in the GI Bleeding category.

—Rebecca Mashaw

References

Schweber A, Brooks C, Agarunov E, Gonda T. Using large sample real world data to study the progression of low risk pancreatic cysts: New onset diabetes as a potential biomarker of malignant transformation. Talk presented at: American College of Gastroenterology 2020 Clinical Meeting, October 26, 2020; virtual.

Wang Y, Zou F, Shah AY, Glitza IC, Richards D, Thomas AS. Comparative study of vedolizumab and infliximab treatment in patients with immune-mediated diarrhea and colitis. Talk presented at: American College of Gastroenterology 2020 Clinical Meeting, October 26, 2020; virtual.

Singh K, Yakubov S, Ahmed J, Nadeem AJ. Statin use reduces the risk of colorectal cancer: an updated meta-analysis and systematic review. Talk presented at: American College of Gastroenterology 2020 Clinical Meeting, October 26, 2020; virtual.

Ramai D, Singh J, Lanke G, et al. Endoscopic resection of t1b esophageal adenocarcinoma is comparable to esophagectomy: a surveillance, epidemiology, and end results database study. Talk presented at: American College of Gastroenterology 2020 Clinical Meeting, October 26, 2020; virtual.

Chey SW, Chey WJ, Jackson K, Eswaran S. Randomized, comparative effectiveness trial of green kiwifruit, psyllium, or prunes in U.S. patients with chronic constipation. Talk presented at: American College of Gastroenterology 2020 Clinical Meeting, October 26, 2020; virtual.

Hakimian S, Hanscom M, Petersile M, Rau P, Foley A, Cave D. Video capsule endoscopy as first procedure for acute gastrointestinal bleeding: An approach to minimizing exposure to Sars-Cov-2 and conserving resources. Talk presented at: American College of Gastroenterology 2020 Clinical Meeting, October 26, 2020; virtual.