Cutting-Edge Advances in Gastroenterology and Hepatology_ Latest Breakthroughs in Diagnostics, Therapies, and Patient Care "Explore the latest innovations in gastroenterology and hepatology, from groundbreaking diagnostic techniques to revolutionary therapies and enhanced patient care strategies. This article delves into cutting-edge advancements that are shaping the future of gastrointestinal health and liver disease management, offering insights into state-of-the-art diagnostic tools, novel treatment approaches, and patient-centered care models. Discover how these breakthroughs are revolutionizing healthcare in the fields of gastroenterology and hepatology."

1. What's new in gastroenterology and
hepatology
ENDOSCOPY:-
Antibiotic prophylaxis before ERCP for biliary obstruction
(February 2024):
For patients with biliary obstruction undergoing endoscopic retrograde
cholangiopancreatography (ERCP), the benefit of antibiotic prophylaxis in all versus
selected patients is uncertain. In a randomized trial including 378 patients with biliary
obstruction undergoing ERCP, antibiotic prophylaxis resulted in a lower risk of
cholangitis compared with no prophylaxis (2 versus 6 percent). Based on these and
older data, we reserve antibiotic prophylaxis for patients at risk for incomplete biliary
drainage with ERCP and await further data before administering antibiotic
prophylaxis to all patients with biliary obstruction.
Pancreatic stenting for preventing pancreatitis after ERCP
(February 2024)
Patients with difficult biliary access are at increased risk for pancreatitis after
endoscopic retrograde cholangiopancreatography (ERCP), which may be prevented
by prophylactic pancreatic stenting. In a trial including 1950 patients at high risk for
post-ERCP pancreatitis, individuals assigned to pancreatic stent placement plus
indomethacin had lower rates of post-ERCP pancreatitis compared with those
assigned to indomethacin alone (11 versus 15 percent). Rates of serious adverse
events were not significantly different between groups. These data support our
approach to prophylactic pancreatic stenting in high-risk patients undergoing ERCP.

2. Motorized spiral enteroscopy for evaluating small bowel disorders
(October 2023)
Device-assisted enteroscopy facilitates direct access to the small bowel, but studies
on motorized spiral enteroscopy are limited. In a trial comparing motorized spiral
enteroscopy with single balloon enteroscopy in 110 adults with suspected small
bowel disorders, rates of complete small bowel examination were higher with
motorized spiral enteroscopy (71 versus 11 percent). Motorized spiral enteroscopy
also resulted in higher diagnostic yield (80 versus 62 percent) and shorter mean
procedure times (58 versus 114 minutes). No major adverse events occurred in
either group. These data show promise, but further studies on safety are needed
before performing motorized spiral enteroscopy routinely in clinical practice. In
addition, its use may be limited by equipment availability and endoscopic expertise.
ESOPHAGEAL AND GASTRIC DISEASE:-
Budesonide oral suspension for eosinophilic esophagitis (March
2024)
In patients with eosinophilic esophagitis (EoE), the use of topical glucocorticoids has
been limited by a lack of regulatory approval and potentially inconsistent drug
delivery. Budesonide oral suspension is a formulation that was recently approved by
the US Food and Drug Administration for treating EoE in adults and pediatric
patients ages 11 years and older. Approval was informed by clinical trials showing
that topical budesonide resulted in higher rates of histologic remission and
symptomatic improvement compared with placebo. We anticipate using budesonide
oral suspension as the preferred topical glucocorticoid for treating EoE.
Dupilumab for refractory eosinophilic esophagitis (February 2024)

3. Few data are available on the use of dupilumab (a monoclonal antibody) for treating
refractory eosinophilic esophagitis. In a cohort study of 46 patients with refractory
eosinophilic esophagitis, dupilumab therapy was associated with histologic remission
(defined as <15 eosinophils/high-power field) in 37 patients (80 percent) and with
symptomatic improvement in 42 patients (91 percent) after a median of six months.
These data support our approach of using dupilumab for patients with eosinophilic
esophagitis who have not responded to other therapies (eg, topical glucocorticoids).
Rifabutin triple therapy for Helicobacter pylori (October 2023)
Management of patients who have failed multiple antibiotic regimens for Helicobacter
pylori is an increasingly frequent challenge. In a randomized trial in which 364
subjects with H. pylori who failed at least two prior treatments were assigned to
rifabutin triple therapy or bismuth quadruple therapy for 14 days, H. pylori eradication
rates were similar in both groups [7]. However, the rifabutin group had a higher
compliance rate and a lower rate of adverse effects. This trial supports current
guidelines and our recommendation to use rifabutin triple therapy as a salvage
treatment for H. pylori.
HEPATOLOGY:-
Elafibranor for treating primary biliary cholangitis (March 2024)
Elafibranor, a dual peroxisome proliferator-activated receptor (PPAR)-alpha and
PPAR-delta agonist, is under investigation for treating primary biliary cholangitis
(PBC). In a trial including 161 patients with PBC who had intolerance or inadequate
response with ursodeoxycholic acid, elafibranor resulted in higher rates of
biochemical response compared with placebo after 52 weeks (51 versus 4 percent).
Elafibranor also resulted in higher rates of normalized alkaline phosphatase (15

4. versus 0 percent). Gastrointestinal side effects (eg, abdominal pain) occurred more
frequently in the elafibranor group. Further studies and regulatory approval are
needed to clarify the role of elafibranor in treating PBC.
Seladelpar for treating primary biliary cholangitis (March 2024)
Seladelpar, a peroxisome proliferator-activated receptor-delta agonist, is under
investigation for treating primary biliary cholangitis (PBC). In a trial including 193
patients with PBC who had intolerance or inadequate response with ursodeoxycholic
acid, seladelpar resulted in higher rates of biochemical response compared with
placebo after 12 months (62 versus 20 percent). In addition, seladelpar resulted in
higher rates of normalized alkaline phosphatase (25 versus 0 percent). For patients
with moderate to severe pruritus, seladelpar reduced symptom severity. These data
show promise, but further studies and regulatory approval are needed before
incorporating seladelpar into clinical practice.
Pyogenic liver abscess and colorectal cancer (February 2024)
Studies from Asia suggest that pyogenic liver abscess is associated with an
increased incidence of colorectal cancer, but studies outside Asia are scarce. In a
10-year retrospective study from 120 hospitals in the United States, the incidence of
colorectal cancer among over 8000 patients with liver abscess was almost fourfold
higher during the first six months after diagnosis of liver abscess compared with
23,000 matched controls without liver abscess. The correlation was not observed
among patients whose liver abscess was due to cholangitis or cholecystitis, and the
type of organism causing the abscess did not correlate with the incidence of cancer.
These findings support prompt screening for colorectal cancer in patients with
pyogenic liver abscesses, particularly in patients without an underlying hepatobiliary
cause.

5. Mortality risk in alcohol-associated liver disease (January 2024)
Few studies have reported the long-term outcomes of patients with alcohol-
associated liver disease (ALD). In a national registry study including over 23,000
patients with ALD diagnosed at a median age of 58 years, 67 percent died during
>100,000 person-years of follow-up and liver disease was the primary cause of
death in 45 percent. The 5- and 10-year mortality rates due to liver disease were 26
and 31 percent, respectively. These data emphasize the importance of treating
patients with alcohol use disorder and may inform strategies to prevent liver-related
mortality in those with ALD.
Model for End-stage Liver Disease (MELD) 3.0 for liver
transplantation (October 2023, Modified December 2023)
The Model for End-stage Liver Disease (MELD) score is used to allocate livers for
transplantation. Recently, the Organ Procurement and Transplantation Network
implemented an updated score, MELD 3.0, to prioritize liver transplantation
candidates aged 12 and older]. MELD 3.0 includes variables from the original model
(ie, serum bilirubin, serum creatinine, and international normalized ratio) in addition
to other inputs (ie, serum sodium, patient sex, and serum albumin) and a lower
creatinine ceiling. The goals of using MELD 3.0 include reducing overall waitlist
mortality and improving access for female liver transplant candidates.
Paracentesis for hospitalized patients with cirrhosis and ascites
(November 2023)
Patients with cirrhosis complicated by ascites are at risk for spontaneous bacterial
peritonitis and other complications. However, the magnitude of risk associated with
deferring diagnostic paracentesis in such patients when they are hospitalized is

6. uncertain. In a large database study comparing late (ie, ≥24 hours) or no
paracentesis with early paracentesis in hospitalized patients with ascites, late
paracentesis or no paracentesis was associated with a higher risk of acute kidney
injury (odds ratio [OR] 2.2 and 1.3, respectively) and inpatient mortality (OR 1.5 and
1.4, respectively). These data support performing diagnostic paracentesis within 24
hours of hospital admission, which is consistent with our practice.
PANCREATIC AND BILIARY DISEASE:-
Risk of pancreatic cancer in stable intraductal papillary mucinous
neoplasms (November 2023)
The optimal duration of pancreatic cancer surveillance in patients with branch duct
intraductal papillary mucinous neoplasms (BD-IPMNs) is unclear. In a study of over
3800 such patients without worrisome features (WFs) or high-risk stigmata (HRS),
42 percent had BD-IPMNs that remained stable in size and did not develop WF/HRS
for at least five years]. Within this group, patients ≥75 years with cysts <30 mm and
those ≥65 years with cysts <15 mm had a standardized incidence ratio for pancreatic
cancer comparable to the general population and low disease-specific mortality.
These data suggest that this subgroup may be able to discontinue pancreatic cancer
surveillance; however, further studies are needed to validate these results.
Microscopic colitis and acute pancreatitis (November 2023)
Microscopic colitis has been associated with several other conditions. In a recent
population-based study including >12,000 patients with microscopic colitis, these
individuals had a twofold increased risk for acute pancreatitis unrelated to gallstones
but no increase in gallstone-related acute pancreatitis compared with matched
controls. The increased risk persisted for more than 10 years after diagnosis.

7. Whether the increase in acute pancreatitis was due to active disease or a side effect
of budesonide is unclear. Further studies are needed to evaluate this association.
Clinical practice update on exocrine pancreatic insufficiency
(November 2023)
The American Gastroenterological Association (AGA) recently published best
practice advice on exocrine pancreatic insufficiency (EPI). The AGA Clinical Practice
Update advises considering a diagnosis of EPI in individuals with moderate-risk
clinical conditions (eg, celiac disease, previous intestinal surgery, longstanding
diabetes mellitus, Zollinger-Ellison syndrome). It emphasizes the importance of
testing for EPI in patients with nonspecific symptoms and cautions against relying on
a response to an empiric trial of pancreatic enzymes to diagnose EPI as this may be
due to a placebo effect. Our approach is consistent with this guidance.
SMALL BOWEL AND COLONIC DISEASE:-
De-escalating combination therapy in patients with inflammatory
bowel disease (March 2024)
In patients with inflammatory bowel disease (IBD), the goal of de-escalating
combination therapy (anti-tumor necrosis factor [TNF] agent plus an
immunomodulator) is to prevent relapse while minimizing adverse effects. However,
the magnitude of the risk for relapse is uncertain. In a meta-analysis of randomized
trials of patients with sustained, glucocorticoid-free IBD remission on combination
therapy (5 trials, 404 patients), relapse rates at one to two years were more than
twofold higher following withdrawal of the anti-TNF agent compared with continuing
combination therapy (32 versus 11 percent). Relapse rates did not increase following
immunomodulator withdrawal. These data support our approach to de-escalating

8. combination therapy by withdrawing the immunomodulator while continuing anti-TNF
maintenance therapy.
Mirikizumab for moderate to severe ulcerative colitis (August 2023,
Modified January 2024)
Therapeutic options for adults with moderate to severe ulcerative colitis (UC) are
expanding. In an induction trial comparing mirikizumab (a monoclonal antibody that
targets the p19 subunit of interleukin-23) with a placebo in nearly 1300 patients,
mirikizumab (300 mg intravenously every four weeks) resulted in higher rates of
clinical remission after 12 weeks (24 versus 13 percent)—in the maintenance trial
including over 500 patients, mirikizumab (200 mg subcutaneously every four weeks)
resulted in higher rates of clinical remission after 40 weeks (50 versus 25 percent).
Based on these data, the US Food and Drug Administration approved mirikizumab
for moderate to severe UC]. We anticipate using mirikizumab as first- or second-line
therapy for adults with moderate to severe UC.
Clinical practice update on risk stratification for colorectal cancer
screening and post polypectomy surveillance (December 2023)
The American Gastroenterological Association (AGA) recently published nine
statements of best practice advice on risk stratification for colorectal cancer (CRC)
screening and post-polypectomy surveillance. They advise basing risk stratification
on an individual's age, a known or suspected predisposing hereditary CRC
syndrome, other CRC predisposing conditions (eg, inflammatory bowel disease),
and/or a family history of CRC. They also suggest that the decision to continue post-
polypectomy surveillance for individuals older than 75 years should be individualized.
Shared decision-making discussions should include an assessment of the risks of

9. incident CRC, procedure-related risks, comorbidities, and life expectancy (>5 years).
Our approach is consistent with this guidance.
Investigational therapy for irritable bowel syndrome with bile acid
diarrhea (November 2023)
Patients with irritable bowel syndrome with predominant diarrhea (IBS-D) frequently
have concurrent bile acid malabsorption. In a randomized trial in which 31 patients
with IBS and bile acid diarrhea were assigned to aldafermin (an investigational
analog of recombinant human fibroblast growth factor 19) or placebo for 28 days, the
aldafermin group had lower bile acid synthesis and improved stool consistency
during week 4 of treatment, but abdominal pain and stool frequency were not
significantly different for the two groups. Treatment-related adverse events were
significantly higher in patients in the aldafermin group, and four patients on
aldafermin had a clinically significant increase in low-density lipoprotein cholesterol.
More studies are needed to clarify if aldafermin has a role in the treatment of IBS-D.
Low-dose tricyclic antidepressants in irritable bowel syndrome
(October 2023)
The efficacy of tricyclic antidepressants (TCAs) in the management of irritable bowel
syndrome (IBS) has not been well established in the primary care setting. In a
pragmatic randomized trial, 463 patients with IBS unresponsive to dietary advice and
first-line therapies in primary care practices were assigned to titrated low-dose
amitriptyline or placebo as a second-line therapy. At six months, patients treated with
low-dose amitriptyline had lower IBS-symptom severity scores and a higher rate of
symptom relief. The most common side effects were related to the anticholinergic
effects of amitriptyline, but the majority were mild. These data support current
guidelines and our recommendation to use TCAs in the management of patients with
IBS.

10. Pozelimab for CD55-deficient protein-losing enteropathy (October
2023)
Protein-losing enteropathies (PLE) are characterized by excessive loss of serum
proteins into the gastrointestinal tract, resulting in hypoproteinemia, edema, and
pleural and pericardial effusions. Pozelimab, a C5 inhibitor, has been approved by
the US Food and Drug Administration (FDA) to treat patients with CD55-deficient
PLE (CHAPLE syndrome) based on an ongoing single-arm phase II/III clinical trial of
10 patients with CHAPLE syndrome and symptomatic hypoalbuminemia. All patients
achieved normalization of albumin by week 12 of treatment with pozelimab and
maintained serum albumin concentrations within the normal range through at least
72 weeks. Improvements were also reported in serum IgG levels and total iron-
binding capacity. Although FDA-approved, long-term safety data are still needed.
OTHER GASTROENTEROLOGY AND NUTRITION:-
Clinical practice update on bloating and distention (November
2023)
The American Gastroenterological Association (AGA) recently published best
practice advice on the evaluation and management of bloating and distention. The
AGA Clinical Practice Update endorses serologic evaluation for celiac disease and
exclusion of carbohydrate enzyme deficiencies with dietary restriction and/or breath
testing, but emphasizes reserving additional evaluation with abdominal imaging and
upper endoscopy for patients with alarm features, recent worsening symptoms, or
abnormal physical examination. Our approach is consistent with this guidance.
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