Journal of clinical gastroenterology最新文献

Background and aims: Mucosal integrity testing (MI) is a diagnostic modality for gastroesophageal reflux disease (GERD). The aim of this study was to evaluate whether MI predicted long-term improvement in reflux symptoms and the ability to discontinue proton pump inhibitors (PPIs).

Methods: Patients with suspected GERD who underwent MI with (N=86) or without (N=25) wireless pH capsule placement were studied. The GERD-questionnaire (GERD-Q) and GERD health-related quality of life (GERD-HRQL) were administered at follow-up. Logistic regression models were used to estimate the predicted probability of reflux resolution and PPI discontinuation.

Key results: Complete resolution (CR) occurred in 73% (81/111), while reflux remained partially resolved (PR) in 27% (30/111) at a median follow-up of 2.5 years. In the CR group, 33% (27/81) no longer required PPI therapy compared with 13% (4/30) in the PR group. Median (IQR) MI patterns of change over distance from the squamocolumnar junction differed in the 2 groups with the CR group having a higher intercept (4130 Ω vs. 3045 Ω, P<0.01) and flatter slope (71 Ω/cm vs. 224 Ω/cm, P<0.01). MI (C-index 0.71) was better than pH (C-index 0.49) at predicting long-term resolution of reflux in this cohort.

Conclusions and inferences: This is the first outcome-based study to show that changes in MI can predict long-term outcomes. One in 3 patients with higher mucosal impedance (suggesting normal mucosal integrity) can discontinue PPIs long-term.

Background: Gastric peroral endoscopic myotomy (G-POEM) is an emerging endoscopic approach to treat refractory gastroparesis (GP). Previous studies have shown short-term benefits, but the long-term outcomes are unclear. This analysis evaluated the short- and long-term efficacy of G-POEM compared with standard medical treatment for adults with refractory GP.

Methods: We performed a systematic review and meta-analysis of studies that evaluated G-POEM for refractory GP. Clinical success was defined variably across studies, most commonly as a ≥50% reduction in Gastroparesis Cardinal Symptom Index (GCSI) scores or combined symptoms and gastric emptying improvement. Pooled estimates for clinical success, GCSI scores, and gastric emptying scintigraphy (GES) were calculated using a random effects model. Adverse events and predictors of long-term outcomes were assessed.

Results: This meta-analysis included 23 studies involving 871 patients who underwent G-POEM. The clinical response rates remained consistently above 70% during the first year, peaked at 79% at 24 months, and reached 81% at 60 months. G-POEM was associated with significant and durable reductions in GCSI scores at 1 month (SMD -2.68, 95% CI: -3.58 to -1.78), 12 months (SMD -2.12, 95% CI: -2.73 to -1.50), and 60 months (SMD -2.55, 95% CI: -4.88 to -0.23), as well as sustained improvements in gastric emptying at 12 months (SMD -33.60%, P <0.05) and 24 months (SMD -36.17%, P <0.05). Adverse events occurred in 7% of the cases. Predictors of long-term clinical success included idiopathic etiology (P=0.04), shorter disease duration (P=0.04), prior botulinum toxin injection (P=0.02), and higher baseline symptom severity (P <0.05).

Conclusions: G-POEM may offer sustained symptoms and gastric emptying improvement in refractory GP, but findings should be interpreted cautiously given reliance on observational data, variable success definitions, lack of sham-controlled evidence, and the absence of a standard effective medical comparator. Careful patient selection remains essential, and randomized trials are needed to confirm its long-term efficacy.

Goals: To investigate the feasibility and effectiveness of an 8-week multimodal physical therapy program for adults with constipation.

Background: Constipation is a common multifactorial digestive disease in adults. A multimodal intervention program may better improve pelvic floor muscle (PFM) function and alleviate symptoms.

Study: This pilot randomized controlled trial was conducted at a Tertiary Medical Center in Taiwan. Adults with functional constipation were recruited and randomly assigned to either the intervention group (IG) or the control group (CG). The IG received a multimodal physical therapy intervention, including therapist-guided lifestyle modification education, twice-weekly physical exercise, and pelvic floor muscle training for 8 weeks. The CG received only 1 session of lifestyle modification education after baseline assessment. Assessments were conducted at baseline and after the 8-week program. Primary outcomes included feasibility measures. Secondary outcomes comprised symptom severity, PFM function, health-related quality of life (HRQOL), and physical activity levels.

Results: A total of 27 participants were recruited (IG: n=14, CG: n=13). The consent rate was 65.2%, with an overall withdrawal rate of 14.8%. No adverse events were reported, and treatment satisfaction was moderate to high. After the 8-week intervention, significant improvements were observed in symptom severity (P=0.003), PFM coordination (P=0.011), PFM strength (P=0.007), HRQOL (P=0.013), and physical activity levels (P=0.037) in the IG, whereas no significant changes were observed in the CG.

Conclusions: An 8-week multimodal physical therapy intervention program appears feasible and potentially effective in improving constipation symptoms, PFM function, HRQOL, and physical activity levels in adults with constipation.

Goals: In this study, we investigate clinical outcomes of inflammatory bowel disease (IBD) patients prescribed opioids after discharge from the hospital or emergency department (ED).

Background: IBD is commonly associated with abdominal pain. Opioids are frequently prescribed to address pain in IBD patients. Importantly, however, there is limited evidence of analgesic benefit. In addition, there are significant safety concerns about opioid use in this setting.

Study: This retrospective study utilized Merative MarketScan claims databases to identify IBD patients who had a hospital or ED visit between 2017 and 2021. Two patient groups were formed based on whether they received an opioid prescription within 7 days of discharge or not. Demographics and baseline clinical features were evaluated. Using χ2 tests and logistic regression, clinical outcomes were compared between groups at 3 time points (1, 3, and 6 mo) starting 7 days after discharge.

Results: Thirty-five thousand eight hundred ninety IBD patients were included in the analysis, with 7892 (22.0%) patients in the opioid prescription group. Using logistic regression analysis, IBD opioid users were found to be significantly more likely to experience repeat ED visits, hospitalizations and opioid prescriptions at multiple time points. IBD opioid users were also more likely to receive corticosteroids and undergo medication escalation during follow-up. Ulcerative colitis opioid users also trended toward being more likely to undergo IBD-associated surgery 6 months after discharge.

Conclusions: Patients who are prescribed opioids after acute hospital care are more likely to have poor clinical outcomes. Physicians should avoid prescribing opioids to IBD patients at discharge from the ED or hospital.

Introduction: Perianal fistulizing Crohn's disease (PFCD) is known to impact patients' quality of life (QoL). However, the interactions between PFCD activity itself with patients' psychosocial well-being and social determinants of health (SDOH) are not fully understood.

Methods: We conducted a survey study of adult patients with clinically active and inactive PFCD defined by the presence or absence of perianal pain and/or drainage between July 2023 and April 2024. The survey included the Crohn's anal fistula quality of life (CAF-QoL) scale, PROMIS scale, IBD Internalized Stigma Scale (modified), Everyday discrimination scale, Health Leads screening tool for SDOH, and Cantril ladder for life satisfaction.

Results: The study included 97 patients with active and 31 with inactive PFCD. Patients with active PFCD reported lower QoL (P<0.001), higher rates of anxiety and depression (P<0.001), decreased life satisfaction (P<0.001), and higher internalized stigma (P<0.001) than patients with inactive PFCD. Lower QoL was associated with lower annual household income (P<0.004) and elevated internalized stigma (P=0.001). Nonwhite patients with active PFCD reported higher internalized stigma related to discrimination experiences (P=0.006). Patients with active PFCD were more likely to report social isolation compared with inactive patients (23.7% vs. 0.0%, P=0.001).

Conclusion: Internalized stigma, nonwhite race, financial resource strain, and social isolation negatively impact patients with PFCD, with those having symptomatic PFCD more affected than those with inactive perianal disease. Providers should screen for these factors to identify vulnerable patients who would benefit from psychosocial care and patient navigation.

Introduction: The ideal resection strategy for rectal neoplasms extending to the dentate line (RNDLs) remains unclear. Transanal surgical approaches and endoscopic mucosal resection (EMR) have their limitations related to inadequate visualization, device maneuverability, and securing an adequate margin on the anal side. Endoscopic submucosal dissection (ESD) appears to overcome some of the limitations of transanal surgical and snare-based endoscopic techniques. Therefore, we evaluated the safety and efficacy of ESD for resection of distal rectal lesions within 2 cm of the dentate line.

Methods: This is a large-scale multicenter retrospective study of patients who underwent ESD for RNDLs between 2015 and 2023. The primary outcomes were the rates of R0 and en bloc resection. Secondary outcomes were immediate and delayed adverse events.

Results: A total of 255 patients across 20 institutions were included (mean age 63.60, women 52.20%). The median lesion size was 40 mm (IQR: 30 to 55), and the median resection time was 110 minutes (IQR: 81 to 169). The en bloc resection rate was 93.70% (n=236), and the rate of R0 resection was 85.40% (n=216). The rate of overall adverse events was 8.70% (n=22, 95% CI: 5.22% to 12.17%), with 13 cases of bleeding (5.10%), 4 cases of full-thickness perforation, and 1 case of postprocedural pain requiring intervention. All AEs were managed conservatively without the need for subsequent surgical or endoscopic interventions.

Conclusions: ESD is safe and effective for resecting RNDLs with high en bloc and R0 resection rates, offering the potential for complete resection with minimal morbidity. It offers advantages over TEN, TAMIS, and other forms of transanal surgery due to the anatomy being less conducive to the equipment required for these techniques, lower cost, and lower rates of complications. However, careful patient selection, meticulous procedural planning, and close follow-up are essential to ensure optimal outcomes and minimize the risk of complications. Long-term follow-up studies and additional prospective controlled trials are warranted.

Goals: To evaluate whether low-volume bowel preparation achieved similar rates of bowel cleansing as standard volume bowel preparations among hospitalized patients and assess the tolerability and safety of their use in this population.

Background: The use of low-volume bowel preparations for colonoscopy preparation is understudied in the inpatient setting, where standard volume preparations remain the standard of care.

Methods: We conducted a multicenter, randomized, single-blind, noninferiority trial. Hospitalized adult patients were randomized to receive low volume (2 L polyethylene glycol and ascorbic acid, 2L PEG+ASC) or standard volume bowel preparation (4 L polyethylene glycol and electrolyte lavage solution, 4L PEG-ELS) before colonoscopy. The primary outcome was noninferiority with respect to the achievement of adequate bowel preparation. Secondary outcomes included rates of electrolyte derangements, acute kidney injury, and patient tolerability.

Results: Five hundred twenty patients were randomized to 2L PEG+ASC (n=257) and 4L PEG-ELS (n=263). In per-protocol analysis, 2L PEG+ASC was noninferior to 4L PEG-ELS for achievement of adequate bowel preparation (55.0% vs. 52.9%, P =0.007). No significant difference was detected with regard to hyponatremia (1.6% vs. 3.3%, P =0.50), hypokalemia (5.3% vs. 8.7%, P =0.27), hyperkalemia (1.1% vs. 0.0% P =0.24), or acute kidney injury (4.3% vs. 3.3%, P =0.73). More 2L PEG+ASC patients found the preparation to be "easy" to tolerate compared with 4L PEG-ELS patients (29.0% vs. 13.1%, P <0.001).

Conclusions: Among hospitalized patients, 2L PEG+ASC was noninferior to 4L PEG-ELS for achieving bowel cleanliness with similar rates of electrolyte disturbance and acute kidney injury and with higher tolerability (ClinicalTrials.gov number, NCT05054036).

Introduction: Adjunct agents in bowel preparation for colonoscopy have the potential to improve procedure outcomes. We performed a systematic review and meta-analysis to investigate the effects of adjunct single-dose linaclotide with bowel prep on colonoscopy outcomes.

Methods: We conducted a comprehensive search in PubMed, Embase, Cochrane, and Web of Science from inception until April 2025 for randomized controlled trials comparing single-dose linaclotide adjunct bowel prep and standard bowel prep. Our pooled data was analyzed for adenoma detection rates (ADR), polyp detection rates (PDR), bowel prep quality, adverse reactions, and other secondary outcomes. A random effects model was used, and the data was presented using pooled odds ratios (OR) and mean differences (MD) with 95% CI.

Results: Seven manuscripts were included with 2209 patients (1267 in the linaclotide group and 942 in the control group). The linaclotide group had a significantly higher ADR (OR: 1.31, 95% CI: 1.04-1.64, P=0.02, I2 0%) and PDR (OR: 1.43, 95% CI: 1.13-1.80, P=0.003, I2 0%). Adequate prep was higher in the linaclotide group among patients with diagnosed constipation (P=0.002). The linaclotide group had a lower incidence of abdominal pain (P=0.0009), bloating (P=0.0006), and sleep disturbance (P=0.002).

Conclusion: Linaclotide used as a single dose adjunct to bowel prep before colonoscopy increased ADR and PDR. Adequate prep was higher with linaclotide in patients with diagnosed constipation. Linaclotide also decreased the odds of abdominal pain, bloating, and sleep disturbances.

Goals: Definitively prove noninferiority of biosimilar infliximab to originator.

Background: The advent of biosimilar agents has made biological medications for inflammatory bowel diseases (IBD) more affordable and widely available. We conducted a noninferiority assessment of the effectiveness of the infliximab biosimilar agent CT-P13 versus the original for treatment of IBD in a nationwide analysis.

Study: We used the Epidemiology Group of the Israeli Inflammatory Bowel Disease Research Nucleus Cohort (epi-IIRN), including data on patients with IBD from all Health Maintenance Organizations (HMO) and conducted a noninferiority analysis of infliximab originator and biosimilar CT-P13 based on time from induction of treatment until failure. Treatment failure was defined as steroid dependency, need for IBD-related surgery, or treatment change to an alternative biological. The groups were matched using a propensity score of 0.15 caliper based on sex, ethnicity, district, socio-economic status, age at diagnosis, disease activity, time until biological treatment, prior biological treatments, surgeries, and hospitalizations.

Results: We compared 564 patients treated with infliximab originator matched to 564 treated with CT-P13. The results proved noninferiority in all parameters, with a margin of d=10% or smaller over 5 years (P<0.05). In time to failure, noninferiority was demonstrated with a d=1% (P=0.0004). Noninferiority was also demonstrated in time to steroid dependency (d=5%, P=0.005), surgery (d=1%, P=0.0006), and transfer to alternative biological drug (d=1%, P<0.001). Subanalyses for Crohn's disease and ulcerative colitis separately yielded similar results.

Conclusions: This study demonstrated noninferiority of infliximab biosimilar CT-P13 in comparison to the original in long-term management of IBD.