{This monograph is a product of the ACG Innovation & Technology (ad-hoc) Committee}
Authors & Committee Members: Sarah Enslin, PA-C, Seth A Gross, MD, FACG; Aasma Shaukat, MD, MPH; Daniel Castaneda, MD, Drew Schembre, MD, Laith Jamil, MD, Marta L. Davila, MD, FACG; Prasad G. Iyer, MD, MS, FACG; Christopher Y. Kim, MD, FACG; Vladimir M. Kushnir, MD, Amandeep K. Shergill, MD, MS; Mark B. Pochapin, MD, FACG; David T. Rubin, MD, FACG; Jay N. Yepuri, MD, MS, FACG and Vivek Kaul, MD, FACG (Committee Chair)
In the last decade, gastroenterology practice has experienced exponential growth in innovation and new technology, both in the pharmaceutical and device sectors. New products have impacted the practice of gastroenterology, endoscopy and hepatology. Patients are aware and well informed on these innovations and specifically request them.
In this evolving landscape, and to keep our members abreast of the evolving technology and innovations, ACG leadership felt strongly that the College should develop a forum which allows members to gather the information related to these new ideas, innovations and technologies.
This impetus led to the creation of the new ACG Innovation & Technology Committee which has a multi-faceted mission. A few examples of the committee’s charge include generation of technology assessment reports, reviews and white papers related to new technology and innovation in Gastroenterology, collaboration with the ACG hands-on endoscopy workshops for training and education in new technology and liaising with our industry partners to address current gaps in the device/innovation realm.
The Most Innovative and Impactful Abstracts at ACG 2018
As one of its first tasks, the Committee summarized the most recent technology-related papers presented at the ACG 2018 Annual Scientific Meeting to highlight their clinical significance. The papers selected by the new ACG Innovation & Technology Committee are summarized below.
Complete Abstracts and References can be accessed here.
A. Innovations in Pharmacotherapeutics
Inflammatory Bowel Disease
1. Sandborn et al. presented a phase 2 induction study of etrasimod (APD334), a selective, oral sphingosine 1-phosphate (S1P) receptor modulator. 156 patients with moderate to severe ulcerative colitis were randomized to once daily (1) etrasimod 1mg, (2) etrasimod 2mg, or (3) placebo. Etrasimod was more effective than placebo, at the 2mg dose (p=0.009).
2. Sands et al. presented a phase 3 UNIFI study on the safety and efficacy of ustekinumab (UST) induction therapy in patients with moderate to severe ulcerative colitis. 961 patients who failed conventional treatment or biologic therapies were randomized into 3 cohorts: (1) 130mg IV induction dose of UST, (2) weight-based dose of UST 6mg/kg, or (3) placebo. Patients who received UST in either dose combination had a higher likelihood of achieving clinical remission, endoscopic healing, clinical response, and mucosal healing at week 8 compared to those who received placebo (p<0.001).
Irritable Bowel Syndrome
3. Lembo et al. studied tenapanor, a selective small molecule inhibitor of the intestinal sodium-hydrogen exchanger-3 (NHE3), for IBS-C. In this safety study, 240 patients were observed for up to 52 consecutive weeks on tenapanor 50mg BID. This medication was well tolerated, with only 2.1% discontinuing it due to adverse events. Most common AE was diarrhea (9.2%), resulting in 1.6% discontinuation rate.
4. Brenner et al. presented a randomized, double-blind study comparing eluxadoline 100 mg twice daily (mixed μ-opioid receptor (OR) and κ-OR agonist and δ-OR antagonist) to placebo in patients with IBS-D. 346 patients were enrolled with a primary endpoint improving worst abdominal pain (WAP) ≥ 40% and Bristol stool score (BSS) < 5 or absence of bowel movement accompanied by ≥ 40% WAP. More patients who received eluxadoline vs placebo reached the primary endpoint (22.7% vs 10.3%, p=0.0022). The eluxadoline arm had improved stool consistency and WAP compared to placebo (27.9% vs 16.7%, p=0.0119; 43.6% vs 31.0%, p=0.0174).
5. Rao et al. studied an orally-administrated Vibrant capsule improving constipation by inducing vibrations in the colon. 182 patients received a single vibration session and 63 patients received three vibration sessions/day. The arm with multiple vibration sessions had a higher rate of complete spontaneous bowel movements (CSBMs) (p<0.0357), hence improving constipation.
Microbiota Therapy
6. Khanna et al. studied an oral microbiota-restoration therapy (RBX7455) to prevent recurrent Clostridium difficile infection (rCDI). Thirty patients who have had ≥ 2 CDI episodes were enrolled to receive either (1) 4 capsules twice daily for 4 days, (2) 4 capsules twice daily for 2 days, or (3) 2 capsules twice daily for 2 days. At 8 weeks, 90% of patients remained negative for rCDI (90% in cohort 1, 80% in cohort 2, and 100% in cohort 3).
Liver
7. Basu et al. studied the efficacy of Sofosbuvir, Velpatasvir, and Veloxpravir in the treatment of patients triple infected with HBV, HIV, and HCV genotype 3 (treatment naïve). 22 patients were recruited. SVR was achieved in 87% of this cohort, demonstrating efficacy of DAAs in a very challenging population.
B. Innovations in Endoscopy
Colonoscopy Bowel Preparation
8. Bachwich et al. presented a Phase 2 study evaluating DCL-101, a novel pill for colon prep, compared to standard 4L polyethylene glycol-electrolyte lavage solutions (PEG-ELS). DCL-101 was better tolerated, with patient ratings of superior taste and tolerability relative to PEG-ELS. Boston Bowel Preparation Score were equivalent in both groups. This could lead to improved patient compliancy when preparing for colonoscopy.
9. Strauss et al. presented a poster on their development of a multidisciplinary clinical care pathway to improve inpatient colonoscopy bowel preparations (BP). An inpatient protocol was developed utilizing note templates and order sets, and key stake holders were trained. In 121 patients pre-intervention and 129 patients post-intervention, they observed an increase in adequate BP in the post-intervention cohort (60.8 vs 79.3%, 95% CI 30.1 to 30.7, p=0.0424).
Improving Adenoma Detection
10. Anderson et al. compared total underwater colonoscopy (TUC) versus CO2 colonoscopy for adenoma detection. 121 participants underwent tandem colonoscopies, 61 having CO2 first followed by TUC and 60 underwent TUC first followed by CO2. Overall polyp miss rate was significantly higher for the TUC first group (34%) versus the CO2 first group (22%), p=0.002. Based on this study, TUC was suboptimal to CO2 in colon insufflation and polyp detection.
11. Rex et al. reported Endocuff decreased examination time (p<0.0001) with no loss of detection of polyps compared to standard colonoscopy (SC) in 200 patients. Endocuff also demonstrated higher adenomas per colonoscopy, adenoma detection rate, sessile serrated polyps (SSP) per colonoscopy, and SSP detection rate vs SC.
Endoscopy
12. Abdul Hamid El-Chafic et al. studied liver biopsy specimen quality, complication rates, and recovery times in patients who underwent a liver biopsy via different techniques; EUS guided liver biopsy (EUS-LB) using 19-gauge core biopsy needle via modified one pass, one actuation wet suction technique, percutaneous liver biopsy (PC-LB) using a 16-gauge core biopsy needle, and transjugular liver biopsy (TJ-LB) via 19-gauge biopsy needle were evaluated. Fewer needle passes were performed in EUS-LB and PC-LB groups, compared to TJ-LB, p<0.001. EUS-LB produced significantly more complete portal triads compared to PC-LB (p<0.001). EUS-LB produced significantly longer aggregate length compared to PC-LB and TJ-LB (p<0.05). Post-procedure recovery time was less among patients undergoing EUS-LB (p<0.05). The rates of complications among all 3 groups were similar.
13. Kantsevoy et al. studied a new endoluminal interventional platform (Lumendi LLC, USA) to improve stabilization for colonic lesions. 137 lesions were removed (126 Endoscopic submucosal dissection (ESD), 11 endoscopic mucosal resection (EMR)). En bloc resection rate in the EMR group was only 18.2%, however en bloc resection rate in the ESD group was 87.1%. Mean endoscopic intervention time was 45.0 ± 40.6 minutes. No significant adverse events occurred, demonstrating a safe and effective platform.
14. Wang et al. presented a poster addressing gastric variceal bleeding and treatment options. EUS-guided coil embolization and absorbable gelatin sponge (Gelfoam) was compared to cyanoacrylate injection (CYA) alone. Five patients treated with Gelfoam were matched in a 1:4 fashion to 20 patients who received CYA. The Gelfoam arm did not require re-intervention at 3 months, compared to 56% of patients who received CYA who did (p=0.046). 3 month mortality in Gelfoam arm was 0% vs 20% in CYA group, p=0.55. Post-procedural hospitalization (3.4 ± 2.2 days vs 8.6 ± 9.9 days, p=0.26) and lower post-procedure transfusion requirements (0.2 ± 0.4 units of blood vs 1.95 ± 2.70 units of blood, p=0.17), favored the Gelfoam arm. Further long-term studies are needed to validate these findings.
Pancreas
15. Hrad et al. studied EUS-guided microforceps to improve pancreatic cystic neoplasms (PCN) diagnosis. Thirty-seven patients (38 cysts) were sampled with EUS-guided microforceps. Cell block samples were analyzed, providing definitive diagnosis in 35/38 cysts (92%). The series demonstrates EUS-microforceps cyst wall biopsy may help better diagnose pancreas cyst type.
16. Zhong et al. studied the role of contrast-enhanced EUS (CE-EUS) to diagnose PCN. 82 patients with suspected PCNs underwent CE-EUS. All patients subsequently underwent surgical resection and pathology confirmation was obtained. The diagnostic accuracy of CE-EUS was greater than CT or MRI (CE-EUS vs CT: 92.3% vs 76.9%, p<0.05; CE-EUS vs MRI: 93.0% vs 78.9%, p<0.05).
17. Linghu et al. studied endoscopic ultrasonography-guided radiofrequency ablation (EUS-RFA) combined with lauromacrogol ablation (LA) for PCNs. Twenty-one patients were included, 5 with MCNs and 16 with serous cystadenomas. Imaging 3 months post-treatment in 17 patients demonstrated complete response in 8 patients (47%), partial response in 6 patients (35%), and persistent cysts in 3 patients (18%). One patient developed mild acute pancreatitis, 1 patient had hyperamylasemia, and 2 patients developed abdominal pain post-procedure. This was a short-term study and the long-term efficacy is yet to be determined.
Artificial Intelligence (AI)
18. Requa et al. used a convolutional neural network (CNN) to predict colon polyp size and width. The CNN predicted size accuracy of 0.97 for polyps < 6mm, 0.97 for polyps 6-9mm, and 0.98 for polyps > 9mm, demonstrating a role for AI to evaluate colon polyps.
19. Guo et al. studied automatic detection of esophageal precancerous and early squamous cancer lesions using AI software. The sensitivity for precancerous lesions or early esophageal squamous cancer was 97.1% and sensitivity for all malignant images was 97.8%. There was however a high false positive rate with specificity of all non-cancerous images of only 76.2%.
C. New Techniques & Care Pathways
Flexible Robotic Endoscopy
20. Gross et al. demonstrated a robotic assisted endoscopic submucosal dissection. Allowing the endoscopists to have a stable platform and tissues traction, Flexible Robotic Endoscopy is a novel, operator-controlled, computer-assisted endoscope platform to assist with EMR/ESD. This endoscope has two accessory channels and a 3D-HD digital camera. The device was tested by an endoscopist with no prior ESD (or robotic) experience, and assessed the operator’s ability to perform distal colonic ESD in a cadaver with suture closure of the defect. A human case demonstrating a recto-sigmoid polyp ESD removal was also shown. This is the first reported experience of this platform with further clinical assessment to come.
Healthcare Delivery Enhancement
21. Tran et al. demonstrated the use of a multidisciplinary team (Enteral Access Team [EAT]) to reduce unnecessary G-tube placement for end of life patients. 49 patients were evaluated by the EAT, 32 (65%) underwent G-tube placement. 94% of the patients who did not have a G-tube placed were end of life. These patients had a decrease in expected length of stay, lower readmission rates, and increased rate of discharge to home.
22. Roth et al. studied the role of telemedicine in an IBD population. The patients who used telemedicine experienced fewer hospitalizations with an increase in non-invasive testing. 29 participants from the TELE-IBD study agreed to participate in a qualitative assessment which was presented at this meeting. 15 of the 29 participants adhered to the self-monitoring program during the course of the trial. These interviews revealed patients felt TELE-IBD was most helpful for those having an IBD flare and for those with shorter duration of disease.
Summary
As highlighted above, the portfolio of innovation and technology related presentations at the 2018 ACG Annual Meeting spans the entire gamut of Gastroenterology. As the evidence base and experience builds up, many of these technologies and innovations will no doubt begin to find a place in modern GI practice sooner or later and impact patient care in a significant manner.