Large bowel preparation may cause a substantial change in the gut microbiota and metabolites. Here, we included a bowel prep group and a no-procedure control group and evaluated the effects of bowel ...prep on the stability of the gut microbiome and metabolome as well as on recovery. Gut microbiota and metabolome compositions were analyzed by 16S rRNA sequencing and capillary electrophoresis time-of-flight mass spectrometry, respectively. Analysis of coefficients at the genus and species level and weighted UniFrac distance showed that, compared with controls, microbiota composition was significantly reduced immediately after the prep but not at 14 days after it. For the gut metabolome profiles, correlation coefficients between before and immediately after the prep were significantly lower than those between before and 14 days after prep and were not significantly different compared with those for between-subject differences. Thirty-two metabolites were significantly changed before and immediately after the prep, but these metabolites recovered within 14 days. In conclusion, bowel preparation has a profound effect on the gut microbiome and metabolome, but the overall composition recovers to baseline within 14 days. To properly conduct studies of the human gut microbiome and metabolome, fecal sampling should be avoided immediately after bowel prep.
To identify gut and oral metagenomic signatures that accurately predict pancreatic ductal carcinoma (PDAC) and to validate these signatures in independent cohorts.
We conducted a multinational study ...and performed shotgun metagenomic analysis of fecal and salivary samples collected from patients with treatment-naïve PDAC and non-PDAC controls in Japan, Spain, and Germany. Taxonomic and functional profiles of the microbiomes were characterized, and metagenomic classifiers to predict PDAC were constructed and validated in external datasets.
Comparative metagenomics revealed dysbiosis of both the gut and oral microbiomes and identified 30 gut and 18 oral species significantly associated with PDAC in the Japanese cohort. These microbial signatures achieved high area under the curve values of 0.78 to 0.82. The prediction model trained on the Japanese gut microbiome also had high predictive ability in Spanish and German cohorts, with respective area under the curve values of 0.74 and 0.83, validating its high confidence and versatility for PDAC prediction. Significant enrichments of Streptococcus and Veillonella spp and a depletion of Faecalibacterium prausnitzii were common gut signatures for PDAC in all the 3 cohorts. Prospective follow-up data revealed that patients with certain gut and oral microbial species were at higher risk of PDAC-related mortality. Finally, 58 bacteriophages that could infect microbial species consistently enriched in patients with PDAC across the 3 countries were identified.
Metagenomics targeting the gut and oral microbiomes can provide a powerful source of biomarkers for identifying individuals with PDAC and their prognoses. The identification of shared gut microbial signatures for PDAC in Asian and European cohorts indicates the presence of robust and global gut microbial biomarkers.
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This study analyzed the gut and oral microbiomes of patients with pancreatic cancer and showed the potential of the microbial species to be used as a biomarker for the disease and its prognosis.
Background
There are limited studies on the results of comprehensive genomic profiling testing for pancreatic cancer tissue specimens by endoscopic ultrasound-guided tissue acquisition (EUS-TA). This ...study aimed to evaluate the proportion of specimens obtained by EUS-TA using a 19-gauge (G) fine-needle biopsy (FNB) needle for unresectable pancreatic cancer (UR-PC) that met the OncoGuide
™
NCC Oncopanel System (NOP) analysis suitability criteria.
Methods
In this single-arm, prospective, phase II study, EUS-TA was performed using a 19G FNB biopsy needle in patients with suspected UR-PC based on a contrast-enhanced computed tomography scan. The primary endpoint was the proportion of patients who met the NOP analysis suitability criteria, with a threshold, expected value, α-error, and power of 40%, 70%, 0.025, and 0.9, respectively, and the planned number of enrolled patients was 33. The NOP analysis suitability criteria were defined as tumor cell content ≥ 20% and tissue size ≥ 4 mm
2
.
Results
Thirty-three patients were enrolled. The procedural success rate was 100%, and the cytodiagnosis of class V was observed in all patients. The proportion of patients meeting the NOP analysis suitability criteria was 63.6% (95% CI 47.22–80.05), which satisfied the predefined criteria to be considered valid. Adverse events occurred in 9.0% of the patients.
Conclusions
The proportion of patients with UR-PC who met the NOP analysis suitability criteria for EUS-TA using a 19G FNB needle was effective for achieving the primary endpoint, making it a valid test method. Adverse events occurred at a higher rate than that previously reported.
Background
Helicobacter pylori
causes peptic ulcers and accounts for over 90% of gastric cancers; however, eradication rates have been declining due to antimicrobial resistance. Vonoprazan (VPZ), a ...potassium-competitive acid blocker, produces rapid and profound gastric acid suppression and has shown promising effects in the improvement of
H. pylori
eradication rates. The efficacy and safety of VPZ-based triple therapy as a first-line regimen for
H. pylori
eradication and its relationship with clarithromycin (CAM) susceptibility were evaluated.
Methods
From May 2015 to September 2017,
H. pylori
-infected patients who underwent esophagogastroduodenoscopy with CAM susceptibility testing were prospectively enrolled. Patients received a 7-day triple therapy regimen (VAC) of VPZ (20 mg), amoxicillin (750 mg), and CAM (200 mg) twice daily. Eradication rates, demographics, CAM susceptibility, and safety profiles were assessed.
Results
VAC was administered to 146 patients (median age: 63, range: 22–85 years) (60% of whom were females) who underwent CAM susceptibility testing, and 131 patients underwent
13
C-urea breath testing to evaluate eradication success. The prevalence of CAM resistance was 34.2%. The overall eradication rates of VAC in per protocol (PP) and “intention to treat” (ITT) analyses were 90.8% (
n
= 131) and 81.5% (
n
= 146), respectively. In PP analysis for CAM susceptibility, the eradication rates of VAC were comparable between CAM-sensitive (91.6%,
n
= 83) and CAM-resistant (89.4%,
n
= 47) strains. The corresponding rates from the ITT analysis were 80.0% (
n
= 95) and 84.0% (
n
= 50), respectively. No adverse events requiring discontinuation of VAC were observed.
Conclusions
CAM-resistant
H. pylori
was prevalent in one-third of patients in the Tokyo metropolitan area. VPZ-based triple therapy was highly effective and well-tolerated irrespective of CAM susceptibility. Therefore, it could be a valuable first-line treatment regimen for
H. pylori
infection.
Objectives
Recent guidelines suggest that imaging surveillance be conducted for 5 years for patients with at most one high-risk feature. If there were no significant changes, surveillance is stopped. ...We sought to validate this follow-up strategy.
Methods
In study 1, data were analysed for 392 patients with intraductal papillary mucinous neoplasms (IPMNs) and at most one high-risk feature who were periodically followed up for more than 1 year with imaging tests. In study 2, data were analysed for 159 IPMN patients without worsening high-risk features after 5 years (stop surveillance group).
Results
In study 1, pancreatic cancer (PC) was identified in 12 patients (27.3%) in the endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) indication group and none in the non-EUS-FNA indication group (
P
< 0.01). In the EUS-FNA indication group, 11 patients (25%) died, whereas 29 (8.3%) died in the non EUS-FNA indication group (
P
< 0.01). In study 2 (stop surveillance group), PC was identified in three patients (1.9%) at 84, 103 and 145 months.
Conclusions
PC risk and mortality for IPMNs not showing significant change for 5 years is likely to be low, and the non-EUS-FNA indication can provide reasonable decisions. However, three patients without worsening high-risk features for 5 years developed PC. The stop surveillance strategy should be reconsidered.
Key points
•
The AGA guidelines provide reasonable clinical decisions for the EUS-FNA indication.
•
In stop surveillance group, PC was identified in 3 patients (1.9%).
•
In stop surveillance group, 2 of 3 PC patients died from PC.
•
Risk of pancreatic cancer in “stop surveillance” group is not negligible.
Abstract
Background
Endoscopic duodenal stent placement is an alternative technique to gastrojejunostomy for gastric outlet obstruction due to pancreatic cancer. We compared the efficacy of ...endoscopic duodenal stent placement with that of gastrojejunostomy for treating patients with pancreatic cancer who are candidates for intensive combination chemotherapies as the first line of treatment.
Methods
This retrospective observational study included 100 patients from 18 institutions in Japan. Inclusion criteria were as follows: (1) cytologically or histologically confirmed adenocarcinoma of the pancreas, (2) good performance status, (3) gastric outlet obstruction scoring system score of 0–1 and (4) no history of treatment for pancreatic cancer.
Results
There was no significant difference in the background characteristics of patients in the endoscopic duodenal stent placement (n = 57) and gastrojejunostomy (n = 43) groups. The median overall survival in the endoscopic duodenal stent placement and gastrojejunostomy groups was 5.9 and 6.0 months, respectively. Clinical success was achieved in 93 cases; the median time to food intake resumption was significantly shorter in the endoscopic duodenal stent placement group (median: 3 days, n = 54) than in the gastrojejunostomy group (median: 5 days, n = 43). Chemotherapy was introduced in 63% of the patients in both groups after endoscopic duodenal stent placement or gastrojejunostomy. Chemotherapy was started earlier in the endoscopic duodenal stent placement group (median: 14 days) than in the gastrojejunostomy (median: 32 days) group.
Conclusions
Endoscopic duodenal stent placement showed similar or better clinical outcomes than gastrojejunostomy. Thus, it might be a promising option in patients with good performance status.
Endoscopic duodenal stent placement could be a promising alternative intervention in patients with good performance status.
Objectives
To evaluate the feasibility and safety of endoscopic ultrasound‐guided choledochoduodenostomy (EUS‐CDS) without fistula dilation using a novel self‐expandable metal stent (SEMS).
Methods
...This retrospective study examined patients who underwent EUS‐CDS for malignant distal biliary obstruction between October 2017 and May 2021 at the National Cancer Center, Japan. The primary outcome was a technical success without fistula dilation. Secondary outcomes were the overall technical success, clinical success, adverse events (AEs), procedure time, recurrent biliary obstruction (RBO), and time to RBO (TRBO).
Results
Forty‐one patients were enrolled; 31 patients underwent EUS‐CDS with fistula dilation using a conventional SEMS with 7.5–8.5‐Fr delivery system (conventional SEMS group), and 10 patients underwent EUS‐CDS without fistula dilation using the novel SEMS with a 5.9‐Fr delivery system (novel SEMS group). In the novel SEMS group, the rate of technical success without fistula dilation was 90%. There were no differences in overall technical success (100% vs. 97%, p = 1.00), clinical success (80% vs. 90%, p = 0.58), and overall AEs (10% vs. 23%, p = 0.65) rates between the novel and conventional SEMS groups. In the novel SEMS group, no early AEs were observed and no bile leakage into the abdominal cavity was observed on the computed tomography scan after the procedure. The median procedure time was significantly shorter in the novel SEMS group (17 min vs. 24 min, p = 0.03). RBO and median TRBO did not differ between the 2 groups.
Conclusions
EUS‐CDS without fistula dilation using the novel SEMS with a 5.9‐Fr delivery system is technically feasible, straightforward, quick, and safe.
Background
There are no previous reports on the main causes of death in biliary tract cancer (BTC) patients. This study aimed to evaluate the main causes of death and survival rates in patients with ...BTC.
Methods
We retrospectively evaluated 143 patients who were diagnosed with unresectable BTC between August 2010 and March 2020. We classified the main causes of death based on laboratory data, imaging studies, and medical records. The main causes of death evaluated included liver failure, cholangitis, cachexia, other causes associated with tumor progression, and complications. We also analyzed survival rates for each main cause of death.
Results
After excluding patients who were lost to follow‐up, living patients, and patients who had no records of laboratory data within 30 days before the date of death, 108 patients were analyzed. The main cause of death was cholangitis in 33 (30.6%), cachexia in 22 (20.4%), liver failure in 10 (9.3%), other causes associated with tumor progression in 18 (16.7%), and complications in 25 (23.2%) patients. Median overall survival (OS) was 334.0 days in the chemotherapy group and 75.0 days in the best supportive care (BSC) group. Survival analyzed according to the main cause of death was significantly different between the chemotherapy and BSC groups; OS for cachexia, cholangitis, liver failure, other causes associated with tumor progression, and complications, respectively, were 453.0, 499.0, 567.0, 205.0, and 327.5 days (p = 0.003) in the chemotherapy group and 219.0, 69.0, 34.0, 93.0, and 56.0 days (p = 0.001) in the BSC group.
Conclusion
The main causes of death in patients with advanced BTC are cholangitis, cachexia, liver failure, other causes associated with tumor progression, and complications. Other causes associated with tumor progression in the chemotherapy group, and liver failure in the BSC group as the main causes of death shortened the survival of BTC patients.
The main causes of death in patients with advanced biliary tract cancer (BTC) are cholangitis, cachexia, liver failure, other causes associated with tumor progression, and complications. Other causes associated with tumor progression in the chemotherapy group, and liver failure in the BSC group as the main causes of death shortened the survival of BTC patients.
Background
To identify differences in incidence and mortality of pancreatic cancer (PC) between intraductal papillary mucinous neoplasm (IPMN) and non‐neoplastic cyst.
Methods
Patients with ...pancreatic cyst (n = 526; 263 with IPMN and 263 with non‐neoplastic cyst matched for age, sex, and diagnosis year) were periodically followed‐up with imaging. Hazard ratio (HR), standardized incidence ratio (SIR), and standardized mortality ratio (SMR) for PC and PC‐related mortality were estimated.
Results
During a mean follow‐up of 57.5 months with 3,376 computed tomography scans and 1,079 magnetic resonance imaging scans, 5‐year cumulative PC incidence was 4.0% for IPMN and 0% for non‐neoplastic cyst, respectively (HR 5.2; P = 0.031). During a mean follow‐up of 73.1 months, 5‐year cumulative PC‐related mortality was 2.6% for IPMN and 0% for non‐neoplastic cyst, respectively (HR 4.5; P = 0.05). Compared with the general population in Japan, patients with IPMN, but not those with non‐neoplastic cyst, had significantly increased risks of PC incidence (SIR 22.03) and related mortality (SMR 15.9).
Conclusions
During long‐term imaging follow‐up, patients with IPMN developed PC over time, whereas none of the patients with non‐neoplastic cyst developed it within 5 years. Compared with the general population, patients with IPMN, but not those with non‐neoplastic cyst, were at risk of PC and related mortality.
Highlight
In this long‐term imaging follow‐up study, Hisada and colleagues demonstrated that patients with intraductal papillary mucinous neoplasm (IPMN) had significantly higher incidence of pancreatic cancer and related death than patients with non‐neoplastic cyst. Compared with the general population, patients with IPMN, but not those with non‐neoplastic cyst, were at increased risk.
Abstract
Background and study aims
For distal malignant biliary obstruction, self-expandable metallic stents (SEMSs) have a larger inner diameter compared to plastic stents, which prolongs time to ...recurrent biliary obstruction (TRBO), although stent-related complications are still a problem. This study aimed to compare the outcomes between using 10– and 6-mm-diameter fully-covered SEMS (FCSEMS) for distal malignant biliary obstruction.
Patients and methods
This single-center, retrospective study included patients with 10-mm or 6-mm-diameter FCSEMS to treat distal malignant biliary obstruction. Clinical success, stent-related adverse events (AEs), cumulative incidence of RBO, factors involved in stent-related AEs, and factors involved in RBO were evaluated.
Results
There were 243 eligible cases between October 2017 and December 2021. The cumulative incidence of RBO did not differ significantly between the 10-mm and 6-mm groups. Stent-related AEs occurred in 31.6 % and 11.4 % of patients between the 10-mm and 6-mm groups, respectively (
P
< 0.01). Pancreatitis occurred in 10.5 % and 3.6 % (
P
= 0.04) and cholecystitis occurred in 11.8 % and 3.0 % of patients (
P
= 0.03) in the 10-mm and 6-mm groups, respectively. In multivariate analysis, the 6-mm stent was extracted as a factor linked to a reduced risk of AEs, but not as a risk factor of RBO.
Conclusions
The 6-mm-diameter FCSEMS for distal malignant biliary obstruction is a well-balanced stent with a cumulative incidence of RBO compatible to that of the 10-mm-diameter FCSEMS and fewer stent-related AEs.
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