Objectives: Comprehensive genomic profiling (CGP) has been approved in Japan since June 2019, enabling mutation-specific therapy. Although tissue sampling via endoscopic ultrasoundguided tissue acquisition (EUS-TA) is standard in pancreatic cancer, reports on obtaining appropriate samples for CGP, especially for the OncoGuide NCC Oncopanel System (NOP) and FoundationOne CDx (FOne), are lacking. Therefore, we investigated the success rate and factors related to appropriate EUS-TA sampling for CGP analysis suitability in unresectable pancreatic ductal adenocarcinoma (UR-PDAC).Methods: Participants comprised 150 UR-PDAC patients who underwent EUS-TA and tumor sample evaluation for CGP analysis suitability between June 2019 and December 2021. The proportion of patients meeting the criteria was evaluated considering tumor size, puncture lesion, presence of metastasis, type and size of puncture needle, suction method, number of punctures, and puncture route.Results: In total, 39.2% (60/153) of samples met NOP analysis suitability criteria and 0% met FOne analysis suitability criteria. The suitability rate was significantly higher with 19G fine-needle biopsy (FNB) (56.0%; 42/75) than with 22G FNB (32.6%; 14/43) and 22G fine-needle aspiration (11.4%; 4/35). Nineteen-gauge needle (odds ratio [OR] 2.53; 95% confidence interval [CI] 1.15-5.57; P = 0.021) and FNB (OR 3.57; 95% CI 1.05-12.20; P = 0.041) were independent factors contributing to NOP analysis suitability. Among 30 patients who underwent actual NOP analysis, the analysis success rate was 100% (30/30).
Conclusion:In sample collection via EUS-TA, 19G and FNB needles contribute to NOP analysis suitability.
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- or 6-mm-diameter FCSEMS to treat distal malignant biliary obstruction. Clinical success, stent-related adverse events, TRBO, factors involved in stent-related adverse events, and factors involved in TRBO were evaluated.
Results
There were 243 eligible cases between October 2017 and December 2021. TRBO did not differ significantly between the 10- and 6-mm groups (267 days and 287 days, respectively; P=0.99). Stent-related adverse events occurred in 31.6% and 11.4% of patients between the 10- 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- and 6-mm groups, respectively. In multivariate analysis, the 6-mm stent was extracted as a factor linked to a reduced risk of adverse events, but not as a risk factor of TRBO.
Conclusions
The 6-mm diameter FCSEMS for distal malignant biliary obstruction is a well-balanced stent with an adequate TRBO and fewer stent-related adverse events.
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.
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