196
CONTRAST ENHANCED HARMONIC EUS-GUIDED VERSUS CONVENTIONAL EUS-GUIDED FINE NEEDLE BIOPSY WITH MACROSCOPIC ON-SITE EVALUATION FOR SOLID PANCREATIC LESIONS: A MULTICENTER RANDOMIZED TRIAL
Date
May 18, 2024
Background:
While endoscopic ultrasound (EUS) guided fine needle biopsy (FNB) is the preferred method of tissue acquisition for pancreatic solid lesions (PSL), false negative result may occur if FNB is performed in the avascular (necrotic) area. Contrast enhanced harmonic EUS (CEH EUS) allows better real-time delineation of lesion vascularity and may help to avoid avascular (necrotic) area during EUS-FNB. This multicenter randomized controlled trial aims to compare the diagnostic performance of CEH EUS-guided vs conventional EUS-guided FNB with macroscopic on-site evaluation (MOSE) for PSL.
Methods:
From 6/2021 to 8/2023, patients aged 18 to 80 years with PSL ≥1cm undergoing EUS-guided tissue acquisition in 3 referral centers in Hong Kong, Italy and Korea were randomized to undergo CEH EUS-guided FNB or conventional EUS-guided FNB. In the CEH EUS group, CEH EUS with SonoVue was used to identify non-enhancing, avascular (necrotic) area in target lesion and guide FNB to the viable area of the lesion. MOSE was used in both study arms to assess specimen adequacy. EUS-FNB was deemed complete if the obtained macroscopic visible core (MVC) was ≥4mm. If MVC was <4mm, FNB was repeated until a total MVC length ≥4mm was obtained. Primary outcome is the false negative rate of the assigned EUS-FNB technique. Secondary outcomes are sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), procedural time and procedure-related complications of the assigned technique.
Results:
128 patients were randomized (64 in CEH EUS group, 64 in conventional EUS group). The baseline patient and PSL characteristics were similar in both groups, except the rate of pancreatic adenocarcinoma (59.5% vs 79.7%, p=0.013) (Table 1). Avascular areas were identified on B mode EUS in 25.0% of PSL in CEH EUS group and 20.3% in conventional EUS group (p=0.526). There was a non-statistically significant increase in avascular area detection to 31.3% in CEH EUS group. The number of passes needed to achieve a MCV length ≥4mm (1 vs 1.5, p=0.480) and the mean MCV length (16.8mm vs 20.6mm, p=0.259) were similar in both groups. The false negative rates of CEH EUS-guided and conventional EUS-guided FNB were low and similar (6.0% vs 7.9%, p>0.999) (Table 2). The sensitivity (94.0% vs 92.1%, p>0.999), specificity (100% vs 100%, p>0.999) and diagnostic accuracy (95.3% vs 92.2%, p=0.718) were high and comparable in both groups. The procedure time was slightly longer in CEH EUS group (28.9min vs 24.4min, p=0.039). The procedure related adverse event rate was low in both groups (1.6% vs 1.6%, p>0.999).
Conclusion:
In this study, while CEH EUS could increase the detection of avascular (necrotic) area, the diagnostic performance of FNB with MOSE guided by CEH EUS or conventional EUS for PSL were comparable with low false negative rate and high diagnostic accuracy.
While endoscopic ultrasound (EUS) guided fine needle biopsy (FNB) is the preferred method of tissue acquisition for pancreatic solid lesions (PSL), false negative result may occur if FNB is performed in the avascular (necrotic) area. Contrast enhanced harmonic EUS (CEH EUS) allows better real-time delineation of lesion vascularity and may help to avoid avascular (necrotic) area during EUS-FNB. This multicenter randomized controlled trial aims to compare the diagnostic performance of CEH EUS-guided vs conventional EUS-guided FNB with macroscopic on-site evaluation (MOSE) for PSL.
Methods:
From 6/2021 to 8/2023, patients aged 18 to 80 years with PSL ≥1cm undergoing EUS-guided tissue acquisition in 3 referral centers in Hong Kong, Italy and Korea were randomized to undergo CEH EUS-guided FNB or conventional EUS-guided FNB. In the CEH EUS group, CEH EUS with SonoVue was used to identify non-enhancing, avascular (necrotic) area in target lesion and guide FNB to the viable area of the lesion. MOSE was used in both study arms to assess specimen adequacy. EUS-FNB was deemed complete if the obtained macroscopic visible core (MVC) was ≥4mm. If MVC was <4mm, FNB was repeated until a total MVC length ≥4mm was obtained. Primary outcome is the false negative rate of the assigned EUS-FNB technique. Secondary outcomes are sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), procedural time and procedure-related complications of the assigned technique.
Results:
128 patients were randomized (64 in CEH EUS group, 64 in conventional EUS group). The baseline patient and PSL characteristics were similar in both groups, except the rate of pancreatic adenocarcinoma (59.5% vs 79.7%, p=0.013) (Table 1). Avascular areas were identified on B mode EUS in 25.0% of PSL in CEH EUS group and 20.3% in conventional EUS group (p=0.526). There was a non-statistically significant increase in avascular area detection to 31.3% in CEH EUS group. The number of passes needed to achieve a MCV length ≥4mm (1 vs 1.5, p=0.480) and the mean MCV length (16.8mm vs 20.6mm, p=0.259) were similar in both groups. The false negative rates of CEH EUS-guided and conventional EUS-guided FNB were low and similar (6.0% vs 7.9%, p>0.999) (Table 2). The sensitivity (94.0% vs 92.1%, p>0.999), specificity (100% vs 100%, p>0.999) and diagnostic accuracy (95.3% vs 92.2%, p=0.718) were high and comparable in both groups. The procedure time was slightly longer in CEH EUS group (28.9min vs 24.4min, p=0.039). The procedure related adverse event rate was low in both groups (1.6% vs 1.6%, p>0.999).
Conclusion:
In this study, while CEH EUS could increase the detection of avascular (necrotic) area, the diagnostic performance of FNB with MOSE guided by CEH EUS or conventional EUS for PSL were comparable with low false negative rate and high diagnostic accuracy.
Table 1. Baseline characteristics of patients and solid pancreatic lesions
Table 2. Procedure details and diagnostic performance of fine needle biopsy guided by CEH EUS and conventional EUS
Presenter
Speakers
Chinese University of Hong Kong
The Chinese University of Hong Kong
Tracks
Related Products
FAECAL MICROBIOTA TRANSPLANTATION FOR POST-ACUTE COVID-19 SYNDROME: AN OPEN-LABEL PILOT TRIAL (FMT-PACS STUDY)
BACKGROUND: Post-acute COVID-19 syndrome (PACS) affects sleep and neuropsychiatric functions but treatment is limited. We aimed to assess the effects of faecal microbiota transplantation (FMT) in alleviating post-COVID insomnia and anxiety…
CHOLECYSTOSCOPY AND LAMS REMOVAL IS ASSOCIATED WITH HIGHER STONE-RELATED COMPLICATIONS AS COMPARED TO LONG TERM LAMS IN SURGICALLY UNFIT PATIENTS WITH EUS-GBD PERFORMED FOR ACUTE CALCULOUS CHOLECYSTITIS
EUS-GBD with lumen apposing stent (LAMS) has been included in ESGE and ASGE guidelines for acute calculous cholecystitis for patients who are unfit for surgery. Whether to perform cholecystoscopy for stone removal and LAMS removal, or the LAMS should be kept for long term is still a controversy…
TRANS-OESOPHAGEAL BIOPSY FOR LUNG MASSES: A PROSPECTIVE ANALYSIS OF PERFORMANCES OF EUS-GUIDED FNB IN A TERTIARY CENTER
Pulmonary masses are a diagnostic challenge in the field of endoscopic ultrasound (EUS) tissue acquisition (TA), due to both an unclear diagnostic accuracy of other available approaches and the need of enough tissue for molecular profiling…
MACHINE LEARNING BASED DIAGNOSIS OF MALIGNANCY DURING BILE DUCT STRICTURE EVALUATION USING CHOLANGIOSCOPY
Introduction: Adenoma per colonoscopy (APC) has recently been proposed as a quality measure for colonoscopy. We evaluated the impact of a novel AI system, compared to standard HD colonoscopy, for APC measurement…
