Prospective clinical trial of EUS-guided choledochoduodenostomy without fistula dilation for malignant distal biliary obstruction.

Background and Objectives: During EUS-guided choledochoduodenostomy (EUS-CDS), fistula dilation before stent insertion is associated with adverse events (AEs), such as bile leakage and peritonitis. We hypothesized that EUS-CDS without fistula dilation using a novel self-expandable metal stent (SEMS) with a thin delivery system could overcome this problem, and we conducted this study to evaluate its feasibility and safety. Methods: This was an open-label, single-arm, phase II study at a single institution. We planned EUS-CDS without fistula dilation using a fully covered SEMS with a 5.9-Fr delivery system for unresectable malignant distal biliary obstruction. The primary outcome was overall technical success. Secondary outcomes were technical success without fistula dilation, procedure time, functional success, time to recurrent biliary obstruction, and AEs. The planned sample size was 25 patients. Results: In total, 24 patients were included in this study. In 21 patients, EUS-CDS was performed as primary drainage. The overall technical success rate was 100% (24 of 24 patients). The technical success rate without fistula dilation was 96% (23 of 24). The median procedure time was 16 min (range, 10-66 min). The functional success rate was 96% (23 of 24). The median time to recurrent biliary obstruction was 148 days (95% confidence interval, 29-266 days). There were no procedure-related AEs. Furthermore, computed tomography immediately after the procedure showed no leakage of contrast medium into the abdominal cavity in any patient. Conclusions: EUS-guided choledochoduodenostomy without fistula dilation using a fully covered SEMS with a 5.9-Fr delivery system is feasible with a high probability and can be achieved quickly while effectively preventing bile leakage and peritonitis.

Advances in the Early Diagnosis of Pancreatic Ductal Adenocarcinoma and Premalignant Pancreatic Lesions.

Pancreatic cancer is one of the most lethal human malignancies, in part because it is often diagnosed at late stages when surgery and systemic therapies are either unfeasible or ineffective. Therefore, diagnosing pancreatic cancer in earlier stages is important for effective treatment. However, because the signs and symptoms may be nonspecific and not apparent until the disease is at a late stage, the timely diagnoses of pancreatic cancer can be difficult to achieve. Recent studies have shown that selective screening and increased usage of biomarkers could improve the early diagnosis of pancreatic cancer. In this review, we discuss recent advancements in the early detection of pancreatic ductal carcinoma and precancerous lesions. These include innovations in imaging modalities, the diagnostic utility of various biomarkers, biopsy techniques, and population-based surveillance approaches. Additionally, we discuss how machine learning methods are being applied to develop integrated methods of identifying individuals at high risk of developing pancreatic disease. In the future, the overall survival of pancreatic cancer patients could be improved by the development and adoption of these new methods and techniques.

Pancreatic Mixed Acinar-neuroendocrine-ductal Carcinoma: A Case Report and Literature Review.

Pancreatic mixed neoplasms are very rare. We herein report a unique case of pancreatic mixed acinar-neuroendocrine-ductal carcinoma with trilineage differentiation. The patient was an 83-year-old woman referred to our hospital due to anemia and a pancreatic mass. Contrast-enhanced computed tomography revealed a 60-mm mass in the pancreas. Subtotal stomach-preserving pancreaticoduodenectomy was performed. The postoperative pathological diagnosis was mixed acinar-neuroendocrine-ductal carcinoma. Postoperative chemotherapy was conducted according to the adenocarcinoma and neuroendocrine carcinoma protocols. The patient died 26 months postoperatively. Choosing appropriate chemotherapy for mixed neoplasms is difficult. Cancer gene panel testing, if possible, may support the choice of therapeutic agents.

Diagnostic Ability of Endoscopic Ultrasound-Guided Tissue Acquisition Using 19-Gauge Fine-Needle Biopsy Needle for Abdominal Lesions.

Attempts at performing endoscopic ultrasound-guided tissue acquisition (EUS-TA) with a 19G needle are increasing because histological diagnosis and comprehensive genomic profiling are a necessity. However, the diagnostic ability of the 19G fine-needle biopsy (FNB) needle, especially the third-generation FNB needle, is unclear and has been retrospectively reviewed. The 19G TopGain needle was used in 147 patients and 160 lesions between September 2020 and December 2021. The technical success rate of the biopsies was 99.4% (159/160). The early adverse event rate was 4.1% (6/147), and moderate or severe adverse event rate occurrence was 2.0% (3/147). The sensitivity, specificity, and accuracy of the 19G TopGain needle for 157 lesions with a confirmed diagnosis were 96.7%, 100%, and 96.8%, respectively. Rescue EUS-TA using the 19G TopGain needle was performed for nine lesions, and a successful diagnosis was made in six of these lesions (66.7%). The diagnostic ability of EUS-TA using the third-generation 19G TopGain needle was favorable. However, the use of 19G FNB needles may increase adverse events. Therefore, EUS-TA with a 19G FNB needle is mainly indicated in lesions where comprehensive genomic profiling may be necessary or the diagnosis could not be determined via EUS-TA using the 22G needle.

Usefulness of a laser-cut covered metal stent with a 7F delivery sheath in endoscopic ultrasound-guided biliary drainage without fistula dilation.

Background and study aims Recently, the utility of endoscopic ultrasound-guided intervention without fistula dilation (EUS-IV WoD) has been reported to prevent adverse events. We clinically evaluated cases in which EUS-IV WoD was attempted using a novel self-expandable metallic stent (SEMS); this is a fully covered, laser-cut SEMS that has a tapered and stiff tip specifically designed for a 0.025-inch guidewire and a relatively thin, 7F delivery system. Patients and methods We retrospectively evaluated cases wherein EUS-IV WoD was attempted using the novel SEMS between March and December 2021. Results Treatment of 11 patients by EUS-IV WoD with the novel SEMS was attempted. The technical success rate for EUS-IV was 100 % and the clinical success rate was 100 %; the success rate for EUS-IV WoD was 72.8 %. Of these, the procedural success rate for EUS-IV WoD was 100 % in EUS-biliary drainage (BD) and 57.1 % in non-EUS-BD. Early adverse events were observed in 27.3 % of patients (3/11): mild abdominal pain in two patients and moderate bleeding in one patient. The abdominal pain cases were both cases of EUS-IV WoD failure and required fistula dilation. Conclusions The novel stent may be useful for EUS-IV WoD, especially in EUS-BD.

Fine-needle biopsy with 19G needle is effective in combination with endoscopic ultrasound-guided tissue acquisition for genomic profiling of unresectable pancreatic cancer.

OBJECTIVES: Comprehensive genomic profiling (CGP) has been approved in Japan since June 2019, enabling mutation-specific therapy. Although tissue sampling via endoscopic ultrasound-guided 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.

Proportion of unresectable pancreatic cancer specimens obtained by endoscopic ultrasound-guided tissue acquisition meeting the OncoGuide™ NCC Oncopanel System analysis suitability criteria: a single-arm, phase II clinical trial.

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 mm2. 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.

A novel endoscopic technique using fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy: the saddle-cross technique (with video).

BACKGROUND: In recent years, the number of patients with hepaticojejunostomy anastomotic strictures has increased. Balloon dilation and placement of multiple plastic stents have proven effective for hepaticojejunostomy anastomotic strictures. However, for refractory strictures, there is often a need for repeated endoscopic procedures within a short period. This study aimed to assess the efficacy and safety of the new saddle-cross technique, which uses two fully covered self-expandable metallic stents. METHODS: This was a retrospective analysis of 20 patients with benign hepaticojejunostomy anastomotic strictures who underwent placement of two fully covered self-expandable metallic stents at the National Cancer Center, Japan, from November 2017 to June 2021. RESULTS: The technical and clinical success rates were 100% (20/20). The median time of the procedure was 61 (range 25-122) min. The scheduled stent removal rate was 70% (14/20). Spontaneous dislodgement of the stent was observed on computed tomography in five patients (25.0%). The non-restenosis rate 12 months after the saddle-cross technique was 88.2% (15/17). Procedure-related early adverse events included mild ascending cholangitis in three patients (15.0%) and sepsis in one patient (5.0%). Procedure-related late adverse events included mild ascending cholangitis in three patients (15.0%) and bile duct hyperplasia in one patient (5.0%). CONCLUSIONS: The saddle-cross technique performed using two fully covered self-expandable metallic stents resulted in promising long-term stricture resolution with a high technical success rate. Based on these findings, the saddle-cross method can be considered an option for the standard procedure for benign hepaticojejunostomy anastomotic strictures.

Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation using a stent with a 5.9-Fr delivery system: Comparison to a conventional procedure with fistula dilation.

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.