Society: ASGE

Background and Aims

Recently macroscopic-onsite evaluation (MOSE) technique for Endoscopic Ultrasound guided Tissue acquisition (EUS-TA) for solid gastrointestinal lesions has been advocated to provide high diagnostic accuracy in settings where rapid- onsite evaluation is not available. However, MOSE technique has not yet been standardized. Our aim was to compare MOSE guided EUS-TA with conventional techniques and to find out the optimum parameters required for MOSE technique.

Materials and Methods

In this prospective randomized study, 96 consecutive adult patients undergoing EUS-TA were randomized to MOSE and conventional groups. MOSE technique was performed by segregating material obtained in each pass into Macroscopically visible Core (MVC), and red paste. Obtaining total MVC length greater than 4 mm was considered complete, and no further passes were taken. Sensitivity, specificity, positive predictive value, negative predictive value, diagnostic yield, diagnostic accuracy was compared between two arms. Optimum length and number of MVC required was also evaluated.

Results

When comparing MOSE group (n=48) with conventional group (n=48), diagnostic accuracy, sensitivity ,specificity, positive predictive value and negative predictive value were 97.9% vs 95.8%,93.3 % vs 79.4%, 100 % vs 100%, 100 % vs 100% and 90% vs 87.8% respectively (Table 1).Diagnostic yield was similar in both the groups (95.8% vs 91.6%, p=0.39).The mean length of MVC obtained was 15.46 ± 3.22 mm and number of MVC obtained was 3.17 ± 0.83 in MOSE group. No significant difference in duration of procedure and adverse events were noted in two groups. Number of passes needed in MOSE group was significantly less then needed in conventional arm ( median 2 vs 3 , mean 2.08 ± 0.28 vs 2.65 ± 0.53, p <0.001). Obtaining a 11.5 mm length of MVC was 93.3% sensitive whereas obtaining total 2.5 number of MVC was 86.7% sensitive to diagnose malignancy (Figure 1).

Conclusion

MOSE technique guided EUS-TA results in fewer number of passes needed to achieve high diagnostic accuracy and diagnostic yield without increasing the procedure duration and adverse events as compared to conventional technique. Obtaining longer length and more number of MVC increases the sensitivity to diagnose malignancy.

<b><u>TABLE 1: Comparing the clinical details, technical parameters, diagnostic accuracy and diagnostic yield between MOSE group and Conventional group. </u></b>

TABLE 1: Comparing the clinical details, technical parameters, diagnostic accuracy and diagnostic yield between MOSE group and Conventional group.

FIGURE 1 : Area under the receiver operating characteristic graph shows that in in patients where Macroscopic onsite evaluation (MOSE) was used, obtaining a total Macroscopic visible core (MVC) length of 11.5 mm had 93.3% sensitivity and obtaining 2.5 MVC cores (each 4 mm) had 86.7% sensitivity in diagnosing malignancy.

FIGURE 1 : Area under the receiver operating characteristic graph shows that in in patients where Macroscopic onsite evaluation (MOSE) was used, obtaining a total Macroscopic visible core (MVC) length of 11.5 mm had 93.3% sensitivity and obtaining 2.5 MVC cores (each 4 mm) had 86.7% sensitivity in diagnosing malignancy.

Background:
Endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) is the gold standard for diagnosing gastric subepithelial lesions (SELs). However, especially in SELs <20 mm, collecting sufficient tissue for pathological diagnosis can sometimes be challenging. To improve the diagnostic accuracy of the small SEL, we have developed a new method, termed traction-assisted EUS-FNB using the clip-with-thread (TA-EUS-FNB). That can fix the lesion to prevent respiratory fluctuation, orient the lesion perpendicular to the endoscope, and obtain counter traction to facilitate puncture. This study aimed to evaluate the diagnostic accuracy of TA-EUS-FNB.
Method:
This is a prospective randomized controlled crossover study conducted from July 2019 to November 2022. Consecutive 30 patients with gastric SELs <20 mm (14 men; mean age 57.7 [± 13.9] years) were enrolled in this study. These patients were randomly assigned to either TA-EUS-FNB first group or the conventional EUS-FNB first group. Four punctures in each patient were performed, namely twice by the designated first method and then twice by the other method. The final diagnosis was determined by surgical pathology (n=13) or, in patients who did not undergo surgery, by biopsy samples such as EUS-FNB (n=17). The primary outcome was set as the diagnostic accuracy of the two methods mentioned above. The specimen adequacy and diagnostic capability of sensitivity, specificity, and positive predictive value to differentiate gastrointestinal stromal tumor (GIST) from non-GIST were analyzed as the secondary outcome.
Result:
The mean tumor size was 15.1 (± 4.0), and the final diagnosis was GIST (n=15, 50%), leiomyoma (n=8, 26.7%), schwannoma (n=2, 6.7%), aberrant pancreas (n=3, 10%), and inflammation (n=2, 6.7%). Compared to conventional EUS-FNB, TA-EUS-FNB has significantly higher diagnostic accuracy (86.7% vs. 63.3%, p=0.037). The specimen adequacy of TA-EUS-FNB was also significantly higher than that of conventional EUS-FNB (90% vs. 66.7%, p=0.028), while the sensitivity and specificity, and PPV of TA-EUS-FNB were comparable to that of conventional EUS-FNB (sensitivity [86.7% vs. 66.7%, p=0.195], specificity [100% vs. 100%], positive predictive value [100% vs. 100%]) (Table).
Conclusion:
The TA-EUS-FNB is superior to the conventional EUS-FNB in specimen adequacy and diagnostic accuracy for SELs <20mm, which should be a good option.

Study design and method

table of outcome

(Introduction) Although the gold standard for diagnosing subepithelial lesions (SELs) is endoscopic ultrasound guided fine-needle aspiration/biopsy (EUS-FNB), its accuracy for SELs <20 mm is low. To overcome this situation, we developed a new diagnostic method to differentiate between gastrointestinal stromal tumor (GIST) and non-GIST by measuring impedance value using an EUS-FNB needle.
(Methods) The impedance of 16 gastric epithelial neoplasms was measured with a conventional impedance probe to determine if the impedance is clinically useful in assessing cell density in Study 1. The impedance values of non-exposed/exposed SELs from 25 cases using the conventional probe in Study 2, and non-exposed SELs from 20 cases using the EUS-FNB needle probe in Study 3 were measured to determine the diagnostic yield of the impedance to differentiate GISTs from non-GISTs.
(Results) There was a significant positive correlation between the impedance and cell density (P=0.030) in Study 1. In Study 2, the impedance value of 99.5 for GIST measured with a conventional probe was significantly higher (P<0.01) than for muscle layer (82.4) and leiomyoma (89.2). The impedance of GIST measured with the EUS-FNB needle was also significantly higher than that of leiomyoma (GIST: 80.2 vs leiomyoma: 71.8, P=0.015). The diagnostic yield of the impedance method to differentiate GIST from non-GIST was 94.4% accuracy, 88.9% sensitivity, 100% specificity, and area under the curve was 0.95. Diagnostic performance was not affected by lesion size (P=0.86) (Study 3).
(Conclusion) Impedance measurement of EUS-FNB to differentiate gastric GISTs from non-GISTs would be a good option, especially if the lesion is less than 20 mm.

Introduction

Endoscopic gallbladder drainage (EGBD) when compared to percutaneous transhepatic cholecystotomy (PTGBD) to have significantly less 1-year adverse event rate in DRAC1 trial for patients who are unfit for surgery. However, how EGBD compares to laparoscopic cholecystectomy (LC) in surgical candidates has not been studied. This study aims to compare the 1-year outcomes of EGBD versus LC in surgical candidates.

Methods
From 1/4/2020 to 31/3/2021, 30 patients were recruited into a prospective case series on EGBD for acute cholecystitis in surgical candidates. Cholecystoscopy was performed in all patients with EGBD at 4-6 weeks and was repeated until complete stone clearance and stent removal. Data on all patients who undergone emergency laparoscopic cholecystectomy during the same period were also retrospective collected. The primary outcome was rates of recurrent biliary events in 1 year. Secondary outcomes include technical and clinical success, hospital stay, procedural time, blood loss, time to resumption of diet, analgesic requirement, 30-day adverse events, rates of recurrent biliary events, unplanned admissions and reinterventions.

Results
There were 30 patients and 79 patients in the EGBD and LC group respectively. The baseline demographics were similar. 4/30 (13.3%) in the EGBD group and 4/79 (5.06%) in the LC group had recurrent biliary events (p=0.14). The rates of unplanned admission and unplanned reinterventions were also similar (p= 1). Technical and clinical success was achieved in 100% of cases in both arms. EGBD required significantly shorter procedural time, less blood loss, early time to resumption of diet and less analgesics requirement. Hospital-stay and 30-day adverse events rates were similar. In the EGBD arm, 4/30 (13.3%) patients had gallstone recurrence and 3/30 (10%) were symptomatic. Robotic cholecystectomy was performed in 1 patient in EGBD group.

Conclusion
EGBD with stone clearance may negate the need for cholecystectomy in a selected group of surgically fit patients with low risk of recurrent stone or acute cholecystitis in the short term. Further data are required confirm the long-term efficacy for EGBD in this group of patients.

Introduction
Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has been proposed as a minimally invasive treatment alternatively to surgery for both functional (F-) and non-functional (NF-) pancreatic neuroendocrine neoplasms (PNENs). Evaluation of EUS-RFA performance in PNENs is limited to case reports and small case series, while data from prospective, multicentre studies are lacking. We performed a prospective multicentre study to evaluate safety and effectiveness of EUS-RFA in patients with F- and NF-PNENs.

Methods
Patients with F- and NF-PNENs were prospectively enrolled from October 2019 to September 2022. Safety was based on adverse events (AEs) occurrence and were graded according to the ASGE lexicon. Effectiveness of treatment was defined as complete disappearance of symptoms related to the hormonal secretion syndrome for F-PNENs, while for NF-PNENs was based on the absence (complete), or persistence of enhancing tissue at imaging. Inclusion criteria were: F-PNENs single lesion ≤20 mm. NF-PNENs lesion >15 and <25mm, ki-67≤5%, absence of distant metastases. The EUSRA system (Starmed, Taewoong, South Korea) was used for EUS-RFA in all patients. After the procedure, follow-up (FU) was performed for up to 1 year.

Results
During the study period, a total of 62 patients (30 F-PNENs and 32 NF-PNENs) were enrolled. Demographic characteristics are reported in Table 1. A total of 51/62 patients (82.3%) completed 6-month FU (F- 24/30, NF- 27/32) while 40/62 (64.5%) completed 1-year FU (F 16/30, NF 24/32). Adverse events occurred in 12.9% (8/62) of patients, 10.0% (3/30) with F-PNENs and 18.7% (5/32) with NF-PNENs and included 5 cases of mild self-limiting acute pancreatitis and one peripancreatic hematoma all treated conservatively, without need for additional procedures or prolongation of hospital stay (grade Mild). Another patient had pancreatic duct injury which was managed endoscopically (grade Moderate). Finally another patient demonstrated post procedural bleeding requiring blood transfusion (grade Moderate). Effectiveness for patients which completed 6- months FU was 95.8% (23/24) for F-PNENs and 96.3% (26/27) for NF-PNENs. Similarly, treatment was successful in 100.0% (16/16) of F-PNENs and 100.0% (24/24) of NF-PNENs (complete response) patients which completed 1-year FU.

Conclusion
In conclusion, preliminary data from our ongoing multicenter prospective study demonstrate that EUS-RFA is safe and highly effective for both F-PNENs and NF-PNENs.

Introduction
In the setting of malignant Gastric Outlet Obstruction (GOO), retrospective studies have shown several advantages of EUS-guided Gastroenterostomy (EUS-GE) compared to enteral stenting and surgical bypass. However no prospective data is available to date.

Methods
All consecutive EUS-GE performed between March-2021 and June-2022 in a tertiary, academic center were included in a Prospective Registry Of Therapeutic EndoscopiC ulTrasound (PROTECT, NCT04813055), with monthly follow-up. The primary aims were Clinical Success (possibility to eat at least soft solids), Adverse Events (AEs, according to ASGE Lexicon) and long-term Dysfunction, shown as frequencies (proportions) and medians (interquartile ranges).

Results
Fifty-one patients [male 56.9%; median age 64 (57.5-72), 74.5% with pancreatic cancer, 64.7% with metastatic disease] underwent EUS-GE during the study period, through the Wireless Simplified Technique (WEST), using an electrocautery-enhanced Lumen Apposing Metal Stent (20mm large in 96.1% of cases). Technical success was 98%. Clinical success was reached in 98% of the as-treated population after 2 (1-2) days. AEs were registered in 6 (11.8%) patients, 3 moderate, 1 severe and 2 fatal (exacerbations of pre-existing cholangitis). Median hospital stay was 6 (4-11) days.
After a median follow-up of 73 (30-126) days, a recurrence of GOO was noted in 3/48 (6.3%). Median estimated Dysfunction-Free Survival at Kaplan-Meier analysis was 376 (95%CI 323-430) days.

Conclusions
In this first, prospective, single-center experience, EUS-GE shows excellent efficacy in relieving malignant GOO, with an acceptable safety profile and long-term patency. These data suggest potential advantages of EUS-GE over both standard alternatives, to be confirmed in randomized comparisons.

Massimo Falconi

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