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1.
Gastroenterology ; 165(1): 244-251.e3, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37061169

ABSTRACT

BACKGROUND & AIMS: Both computer-aided detection (CADe)-assisted and Endocuff-assisted colonoscopy have been found to increase adenoma detection. We investigated the performance of the combination of the 2 tools compared with CADe-assisted colonoscopy alone to detect colorectal neoplasias during colonoscopy in a multicenter randomized trial. METHODS: Men and women undergoing colonoscopy for colorectal cancer screening, polyp surveillance, or clincial indications at 6 centers in Italy and Switzerland were enrolled. Patients were assigned (1:1) to colonoscopy with the combinations of CADe (GI-Genius; Medtronic) and a mucosal exposure device (Endocuff Vision [ECV]; Olympus) or to CADe-assisted colonoscopy alone (control group). All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was adenoma detection rate (percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, advanced adenomas and serrated lesions detection rate, the rate of unnecessary polypectomies (polyp resection without histologically proven adenomas), and withdrawal time. RESULTS: From July 1, 2021 to May 31, 2022, there were 1316 subjects randomized and eligible for analysis; 660 to the ECV group, 656 to the control group). The adenoma detection rate was significantly higher in the ECV group (49.6%) than in the control group (44.0%) (relative risk, 1.12; 95% CI, 1.00-1.26; P = .04). Adenomas detected per colonoscopy were significantly higher in the ECV group (mean ± SD, 0.94 ± 0.54) than in the control group (0.74 ± 0.21) (incidence rate ratio, 1.26; 95% CI, 1.04-1.54; P = .02). The 2 groups did not differ in term of detection of advanced adenomas and serrated lesions. There was no significant difference between groups in mean ± SD withdrawal time (9.01 ± 2.48 seconds for the ECV group vs 8.96 ± 2.24 seconds for controls; P = .69) or proportion of subjects undergoing unnecessary polypectomies (relative risk, 0.89; 95% CI, 0.69-1.14; P = .38). CONCLUSIONS: The combination of CADe and ECV during colonoscopy increases adenoma detection rate and adenomas detected per colonoscopy without increasing withdrawal time compared with CADe alone. CLINICALTRIALS: gov, Number: NCT04676308.


Subject(s)
Adenoma , Colorectal Neoplasms , Male , Humans , Female , Colonoscopy , Adenoma/diagnostic imaging , Adenoma/pathology , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/pathology , Mucous Membrane , Computers
2.
Gastrointest Endosc ; 99(4): 587-595.e1, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37951279

ABSTRACT

BACKGROUND AND AIMS: Ampullary lesions (ALs) of the minor duodenal papilla are extremely rare. Endoscopic papillectomy (EP) is a routinely used treatment for AL of the major duodenal papilla, but the role of EP for minor AL has not been accurately studied. METHODS: We identified 20 patients with ALs of minor duodenal papilla in the multicentric database from the Endoscopic Papillectomy vs Surgical Ampullectomy vs Pancreatitcoduodenectomy for Ampullary Neoplasm study, which included 1422 EPs. We used propensity score matching (nearest-neighbor method) to match these cases with ALs of the major duodenal papilla based on age, sex, histologic subtype, and size of the lesion in a 1:2 ratio. Cohorts were compared by means of chi-square or Fisher exact test as well as Mann-Whitney U test. RESULTS: Propensity score-based matching identified a cohort of 60 (minor papilla 20, major papilla 40) patients with similar baseline characteristics. The most common histologic subtype of lesions of minor papilla was an ampullary adenoma in 12 patients (3 low-grade dysplasia and 9 high-grade dysplasia). Five patients revealed nonneoplastic lesions. Invasive cancer (T1a), adenomyoma, and neuroendocrine neoplasia were each found in 1 case. The rate of complete resection, en-bloc resection, and recurrences were similar between the groups. There were no severe adverse events after EP of lesions of minor papilla. One patient had delayed bleeding that could be treated by endoscopic hemostasis, and 2 patients showed a recurrence in surveillance endoscopy after a median follow-up of 21 months (interquartile range, 12-50 months). CONCLUSIONS: EP is safe and effective in ALs of the minor duodenal papilla. Such lesions could be managed according to guidelines for EP of major duodenal papilla.


Subject(s)
Ampulla of Vater , Common Bile Duct Neoplasms , Duodenal Neoplasms , Pancreatic Neoplasms , Humans , Treatment Outcome , Ampulla of Vater/surgery , Ampulla of Vater/pathology , Endoscopy, Gastrointestinal , Pancreatic Ducts/pathology , Pancreatic Neoplasms/pathology , Duodenal Neoplasms/pathology , Common Bile Duct Neoplasms/surgery , Common Bile Duct Neoplasms/pathology , Retrospective Studies
3.
Endoscopy ; 56(4): 249-257, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38237633

ABSTRACT

INTRODUCTION: Endoscopic ultrasound (EUS)-guided drainage of symptomatic pancreatic fluid collections (PFCs) using the Hot-Axios device has recently been associated with a significant risk of bleeding. This adverse event (AE) seems to occur less frequently with the use of a different device, the Spaxus stent. The aim of the current study was to compare the rates of bleeding between the two stents. METHODS: Patients admitted for treatment of PFCs by EUS plus lumen-apposing metal stent in 18 endoscopy referral centers between 10 July 2019 and 28 February 2022 were identified and their outcomes compared using a propensity-matching analysis. RESULTS: 363 patients were evaluated. After a 1-to-1 propensity score match, 264 patients were selected (132 per group). The technical and clinical success rates were comparable between the two groups. Significantly more bleeding requiring transfusion and/or intervention occurred in the Hot-Axios group than in the Spaxus group (6.8% vs. 1.5%; P = 0.03); stent type was a significant predictor of bleeding in both univariate and multivariate regression analyses (P = 0.03 and 0.04, respectively). Bleeding necessitating arterial embolization did not however differ significantly between the two groups (3.0% vs. 0%; P = 0.12). In addition, the Hot-Axios was associated with a significantly higher rate of overall AEs compared with the Spaxus stent (9.8% vs. 3.0%; P = 0.04). CONCLUSION: Our study showed that, in patients with PFCs, bleeding requiring transfusion and/or intervention occurred significantly more frequently with use of the Hot-Axios stent than with the Spaxus stent, although this was not the case for bleeding requiring embolization.


Subject(s)
Pancreas , Pancreatic Diseases , Humans , Retrospective Studies , Stents/adverse effects , Endosonography/adverse effects , Drainage/adverse effects , Hemorrhage/etiology , Endoscopy, Gastrointestinal , Treatment Outcome
4.
Dig Endosc ; 36(3): 351-358, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37253185

ABSTRACT

OBJECTIVES: Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in patients with distal malignant biliary obstruction (DMBO). Biliary drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. In a palliative setting the endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) could represent an easy and valid option. We performed a prospective study with a new EC-LAMS with the primary aim to assess the clinical success rate of EUS-GBD as a first-line approach to the palliation of DMBO. METHODS: In all, 37 consecutive patients undergoing EUS-GBD with a new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease >15% within 24 h and >50% within 14 days after EC-LAMS placement. RESULTS: The mean age was 73.5 ± 10.8 years; there were 17 male patients (45.9%). EC-LAMS placement was technically feasible in all patients (100%) and the clinical success rate was 100%. Four patients (10.8%) experienced adverse events, one bleeding, one food impaction, and two cystic duct obstructions because of disease progression. No stent-related deaths were observed. The mean hospitalization was 7.7 ± 3.4 days. Median overall survival was 4 months (95% confidence interval 1-8). CONCLUSION: Endoscopic ultrasound-guided gallbladder drainage with the new EC-LAMS is a valid option in palliative endoscopic biliary drainage as a first-step approach in low survival patients with malignant jaundice unfit for surgery. A smaller diameter EC-LAMS should be preferred, particularly if the drainage is performed through the stomach, to avoid potential food impaction, which could result in stent dysfunction.


Subject(s)
Cholestasis , Jaundice , Humans , Male , Middle Aged , Aged , Aged, 80 and over , Gallbladder , Prospective Studies , Cholestasis/diagnostic imaging , Cholestasis/etiology , Cholestasis/surgery , Endosonography/methods , Jaundice/complications , Drainage/methods , Stents/adverse effects , Cholangiopancreatography, Endoscopic Retrograde/methods , Ultrasonography, Interventional/methods
5.
Gastrointest Endosc ; 98(2): 191-198, 2023 08.
Article in English | MEDLINE | ID: mdl-36990125

ABSTRACT

BACKGROUND AND AIMS: The role of the newer EUS fine-needle biopsy needles in lymphadenopathies (LAs) is still under evaluation. We aimed to evaluate the diagnostic accuracy and adverse event rate of EUS-guided fine-needle biopsy sampling (EUS-FNB) in diagnosing LAs. METHODS: From June 2015 to June 2022, all patients referred to 4 institutions for EUS-FNB of mediastinal and abdominal LAs were enrolled. Twenty-two-gauge Franseen tip or 25-gauge fork-tip needles were used. The criterion standard for positive results was surgery or imaging and clinical evolution over a follow-up of at least 1 year. RESULTS: One hundred consecutive patients were enrolled, consisting of those with a new diagnosis of LA (40%), presence of LA with a previous history of neoplasia (51%), or suspected lymphoproliferative disease (9%). EUS-FNB was technically feasible in all LA patients with 2 to 3 passes (mean, 2.62 ± .93). The overall sensitivity, positive predictive value, specificity, negative predictive value, and accuracy for EUS-FNB were 96.20%, 100%, 100%, 87.50%, and 97.00%, respectively. Histologic analysis was feasible in 89% of cases. Cytologic evaluation was performed in 67% of specimens. A statistical difference between the accuracy of the 22-gauge or 25-gauge needle (P = .63) was not found. A subanalysis on lymphoproliferative disease revealed a sensitivity and accuracy of 89.29% and 90.0%, respectively. No adverse events were recorded. CONCLUSIONS: EUS-FNB with new end-cutting needles is a valuable and safe method to diagnose LAs. The high quality of histologic cores and the good amount of tissue allowed a complete immunohistochemical analysis of metastatic LAs and precise subtyping of the lymphomas. (Clinical trial registration number: NCT02855151.).


Subject(s)
Lymphadenopathy , Lymphoma , Neoplasms , Pancreatic Neoplasms , Humans , Prospective Studies , Endoscopic Ultrasound-Guided Fine Needle Aspiration/adverse effects , Endoscopic Ultrasound-Guided Fine Needle Aspiration/methods , Lymphadenopathy/diagnosis , Lymphoma/diagnosis , Lymphoma/pathology , Pancreatic Neoplasms/pathology
6.
Endoscopy ; 55(2): 129-137, 2023 02.
Article in English | MEDLINE | ID: mdl-36044915

ABSTRACT

BACKGROUND : The advantage of using the macroscopic on-site evaluation (MOSE) technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) performed with 22G Franseen needles has not been investigated. We aimed to compare EUS-FNB with MOSE vs. EUS-FNB performed with three needle passes. METHODS : This randomized trial involved 10 Italian referral centers. Consecutive patients referred for EUS-FNB of pancreatic or nonpancreatic solid lesions were included in the study and randomized to the two groups. MOSE was performed by gross visualization of the collected material by the endoscopists and considered adequate when a white/yellowish aggregate core longer than 10 mm was retrieved. The primary outcome was diagnostic accuracy. Secondary outcomes were specimen adequacy, number of needle passes, and safety. RESULTS : 370 patients with 234 pancreatic lesions (63.2 %) and 136 nonpancreatic lesions (36.8 %) were randomized (190 EUS-FNB with MOSE and 180 with standard EUS-FNB). No statistically significant differences were found between EUS-FNB with MOSE and conventional EUS-FNB in terms of diagnostic accuracy (90.0 % [95 %CI 84.8 %-93.9 %] vs. 87.8 % [95 %CI 82.1 %-92.2 %]; P = 0.49), sample adequacy (93.1 % [95 %CI 88.6 %-96.3 %] vs. 95.5 % [95 %CI 91.4 %-98 %]; P = 0.31), and rate of adverse events (2.6 % vs. 1.1 %; P = 0.28). The median number of passes was significantly lower in the EUS-FNB with MOSE group (1 vs. 3; P < 0.001). CONCLUSIONS : The accuracy of EUS-FNB with MOSE is noninferior to that of EUS-FNB with three needle passes. MOSE reliably assesses sample adequacy and reduces the number of needle passes required to obtain the diagnosis with a 22G Franseen needle.


Subject(s)
Pancreatic Neoplasms , Humans , Endoscopic Ultrasound-Guided Fine Needle Aspiration/methods , Image-Guided Biopsy , Pancreas/diagnostic imaging , Pancreas/pathology , Pancreatic Neoplasms/diagnosis , Pancreatic Neoplasms/pathology
7.
Liver Int ; 43(8): 1783-1792, 2023 08.
Article in English | MEDLINE | ID: mdl-37269164

ABSTRACT

BACKGROUND: Gastric varices (GVs) are conventionally managed with endoscopic cyanoacrylate (E-CYA) glue injection. Endoscopic ultrasound (EUS)-guided therapy using combination of coils and CYA glue (EUS-CG) is a relatively recent modality. There is limited data comparing the two techniques. METHODOLOGY: This international multicentre study included patients with GV undergoing endotherapy from two Indian and two Italian tertiary care centres. Patients undergoing EUS-CG were compared with propensity-matched E-CYA cases from a cohort of 218 patients. Procedural details such as amount of glue, number of coils used, number of sessions required for obliteration, bleeding after index procedure rates and need for re-intervention were noted. RESULTS: Of 276 patients, 58 (male 42, 72.4%; mean age-44.3 ± 12.1 years) underwent EUS-CG and were compared with 118 propensity-matched cases of E-CYA. In the EUS-CG arm, complete obliteration at 4 weeks was noted in 54 (93.1%) cases. Compared to the E-CYA cohort, EUS-CG arm showed significantly lower number of session (1.0 vs. 1.5; p < 0.0001) requirement, lower subsequent-bleeding episodes (13.8% vs. 39.1%; p < 0.0001) and lower re-intervention (12.1% vs. 50.4%; p < 0.001) rates. On multivariable regression analysis, size of the varix (aOR-1.17; CI 1.08-1.26) and technique of therapy (aOR-14.71; CI 4.32-50.0) were significant predictors of re-bleeding. A maximum GV size >17.5 mm had a 69% predictive accuracy for need for re-intervention. CONCLUSION: Endoscopic ultrasound-guided therapy of GV using coil and CYA glue is a safe technique with better efficacy and lower re-bleeding rates on follow-up compared to the conventional endoscopic CYA therapy.


Subject(s)
Esophageal and Gastric Varices , Hemostasis, Endoscopic , Humans , Male , Esophageal and Gastric Varices/diagnostic imaging , Esophageal and Gastric Varices/therapy , Gastrointestinal Hemorrhage/diagnostic imaging , Gastrointestinal Hemorrhage/therapy , Hemostasis, Endoscopic/methods , Treatment Outcome , Endosonography/methods , Cyanoacrylates
8.
Neuroendocrinology ; 113(10): 1024-1034, 2023.
Article in English | MEDLINE | ID: mdl-37369186

ABSTRACT

INTRODUCTION: Ampullary neuroendocrine neoplasia (NEN) is rare and evidence regarding their management is scarce. This study aimed to describe clinicopathological features, management, and prognosis of ampullary NEN according to their endoscopic or surgical management. METHODS: From a multi-institutional international database, patients treated with either endoscopic papillectomy (EP), transduodenal surgical ampullectomy (TSA), or pancreaticoduodenectomy (PD) for ampullary NEN were included. Clinical features, post-procedure complications, and recurrences were assessed. RESULTS: 65 patients were included, 20 (30.8%) treated with EP, 19 (29.2%) with TSA, and 26 (40%) with PD. Patients were mostly asymptomatic (n = 46; 70.8%). Median tumor size was 17 mm (12-22), tumors were mostly grade 1 (70.8%) and pT2 (55.4%). Two (10%) EP resulted in severe American Society for Gastrointestinal Enterology (ASGE) adverse post-procedure complications and 10 (50%) were R0. Clavien 3-5 complications did not occur after TSA and in 4, including 1 postoperative death (15.4%) of patients after PD, with 17 (89.5%) and 26 R0 resection (100%), respectively. The pN1/2 rate was 51.9% (n = 14) after PD. Tumor size larger than 1 cm (i.e., pT stage >1) was a predictor for R1 resection (p < 0.001). Three-year overall survival and disease-free survival after EP, TSA, and PD were 92%, 68%, 92% and 92%, 85%, 73%, respectively. CONCLUSION: Management of ampullary NEN is challenging. EP should not be performed in lesions larger than 1 cm or with a endoscopic ultrasonography T stage beyond T1. Local resection by TSA seems safe and feasible for lesions without nodal involvement. PD should be preferred for larger ampullary NEN at risk of nodal metastasis.


Subject(s)
Ampulla of Vater , Common Bile Duct Neoplasms , Duodenal Neoplasms , Neuroendocrine Tumors , Humans , Ampulla of Vater/surgery , Ampulla of Vater/pathology , Pancreaticoduodenectomy/methods , Prognosis , Pancreatectomy , Common Bile Duct Neoplasms/surgery , Common Bile Duct Neoplasms/pathology , Duodenal Neoplasms/surgery , Neuroendocrine Tumors/pathology , Retrospective Studies , Treatment Outcome
9.
Dig Dis ; 41(5): 819-821, 2023.
Article in English | MEDLINE | ID: mdl-36596281

ABSTRACT

Gastric outlet obstruction is a condition characterized by inadequate gastric emptying due to benign or malignant conditions inducing an inadequate oral intake. In recent years, a novel therapeutic treatment for this condition is given by the use of electrocautery lumen-apposing metal stents. In this case report, we want to present an example of a benign condition treated by endoscopic ultrasound-guided gastroenterostomy with the bi-flanged SpaxusTM stent (Taewoong Medical Co.) mounted on electrocautery catheter.


Subject(s)
Gastric Outlet Obstruction , Ultrasonography, Interventional , Humans , Ultrasonography, Interventional/adverse effects , Endosonography/adverse effects , Gastroenterostomy/adverse effects , Gastric Outlet Obstruction/diagnostic imaging , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Stents/adverse effects
10.
Gastrointest Endosc ; 95(1): 115-122, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34339667

ABSTRACT

BACKGROUND AND AIMS: Electrocautery-tip lumen-apposing metal stents (EC-LAMSs) have extended the indications of therapeutic EUS. We aimed to retrospectively evaluate safety and technical and clinical success of a newly developed EC-LAMS, the Hot-Spaxus (Taewoong Medical Co, Gimpo, Korea), for various EUS-guided procedures. METHODS: We included and retrospectively analyzed consecutive patients at 8 tertiary care referral centers who had undergone EUS interventional procedures using the Hot-Spaxus between October 2018 and February 2021. RESULTS: Of 58 included patients (male-to-female, 36:22; mean age, 63.5 ± 14.9 years), 29 had undergone pancreatic fluid collection drainage (50%), 22 (37.9%) biliary drainage for malignant distal obstruction, 3 (5.1%) gallbladder drainage for acute cholecystitis, 3 gastroenteroanastomoses, and 1 (1.7%) pelvic collection drainage. Technical success was achieved in 54 of 58 patients (93.1%) and clinical success in all 58. Adverse events occurred in 6 patients (11.1%): 2 early (3.7%), 1 late (1.8%), and 3 long term (5.6%). The outcomes were similar to those observed in a control group of patients treated with the Hot-Axios (Boston Scientific, Marlborough, Mass, USA), the other available EC-LAMS. CONCLUSIONS: Our study showed that the novel EC-LAMS has high technical and clinical success rates for various interventional EUS indications. Future multicenter prospective studies will better clarify the role of this new EC-LAMS for different indications.


Subject(s)
Endosonography , Stents , Aged , Drainage , Electrocoagulation , Female , Humans , Male , Middle Aged , Prospective Studies , Retrospective Studies , Ultrasonography, Interventional
11.
Dig Dis ; 40(4): 526-529, 2022.
Article in English | MEDLINE | ID: mdl-34348270

ABSTRACT

BACKGROUND AND STUDY AIMS: Recently, a new electrocautery lumen-apposing metal stent (EC-LAMS) has been launched. The primary aim of our study was to assess the feasibility of the freehand placement with intra-channel release of the new EC-LAMS. The secondary aims were to assess technical and clinical outcomes and rates of adverse events. PATIENTS AND METHODS: We retrospectively evaluated 5 patients (3 F; mean age: 75.6 ± 14.6 years) who underwent new EC-LAMS placement for different indications (cholecystitis, malignant biliary obstruction, and malignant gastric outlet obstruction). We described all the procedures of EC-LAMS placement, providing also a video of one of them (see online suppl. material; for all online suppl. material, see www.karger.com/doi/10.1159/000518539). RESULTS: Technical and clinical success was achieved in all patients who underwent new EC-LAMS placement, and no AEs were experienced. All of the EC-LAMS were placed using the freehand technique with intra-channel release. CONCLUSIONS: Our initial experience with the new EC-LAMS showed a good performance of this device for different indications, especially if the stents are placed freehand and with intra-channel release. Further studies are needed to confirm our preliminary data and first impression about this new EC-LAMS.


Subject(s)
Electrocoagulation , Stents , Aged , Aged, 80 and over , Electrocoagulation/methods , Humans , Metals , Middle Aged , Referral and Consultation , Retrospective Studies , Stents/adverse effects
12.
Gastrointest Endosc ; 93(3): 597-604.e5, 2021 03.
Article in English | MEDLINE | ID: mdl-32640200

ABSTRACT

BACKGROUND AND AIMS: EUS-guided biopsy sampling is the method of choice for obtaining pancreatic tissue. Next-generation sequencing (NGS) has been applied to EUS-guided biopsy sampling and may classify patients based on specific molecular profiles. Our study aimed to compare side-by-side the diagnostic yield achievable by genetic identification of somatic mutations detected with NGS versus histologic and cytologic typing in locally advanced pancreatic carcinoma (LAPC) in samples acquired under EUS guidance. METHODS: We conducted a prospective comparative pilot study at Humanitas Research Hospital. The study included 33 patients referred for LAPC who underwent EUS-guided tissue acquisition using a 22-gauge Franseen needle. Material was obtained for both pathologic diagnosis and DNA extraction and targeted NGS analysis with the AmpliSeq Comprehensive Panel v3 (Illumina Inc, San Diego, Calif, USA). Twenty-one genes were prioritized for somatic mutation detection. RESULTS: The final diagnosis was pancreatic ductal adenocarcinoma (PDAC) in all patients (100%). A macroscopic core was obtained in 30 patients (91%). In 3 lesions no cores adequate for histologic analysis were obtained, but cytologic analysis revealed tumoral cells from PDAC. DNA was extracted from 32 of 33 samples (97%), most of which (27/32) carried at least 2 clearly pathogenic mutations in different genes. Detection of K-ras mutation allowed for molecular diagnosis of PDAC in most of the patients (30/32). CONCLUSIONS: In our study we demonstrated that proper tissue specimens obtained under EUS guidance allowed DNA sample extraction and subsequent NGS analysis in 97% of cases. These results support the potential role of NGS as a complementary diagnostic test to be implemented in association with standard diagnostic modalities. (Clinical trial registration number: NCT03578939.).


Subject(s)
Adenocarcinoma , Pancreatic Neoplasms , Adenocarcinoma/diagnosis , Adenocarcinoma/genetics , Endoscopic Ultrasound-Guided Fine Needle Aspiration , High-Throughput Nucleotide Sequencing , Humans , Pancreatic Neoplasms/diagnosis , Pancreatic Neoplasms/genetics , Pilot Projects , Prospective Studies , Pancreatic Neoplasms
13.
Dig Endosc ; 33(1): 118-124, 2021 Jan.
Article in English | MEDLINE | ID: mdl-32333617

ABSTRACT

BACKGROUND AND AIM: In presence of malignant dysphagia, in patients unfit for surgery, the placement of a self-expandable metal stent (SEMS) represents a safe and effective palliative treatment. Esophageal stents (ES) present an over-the-wire mechanism where the stent is deployed under X-ray control. Recently a through-the-scope (TTS) ES was launched. The aim of our retrospective study is to assess the technical and clinical success of the new TTS-ES. MATERIALS AND METHODS: Patients with malignant dysphagia caused by esophageal cancer or ab-extrinsic compression, who underwent TTS esophageal stent in six Italian endoscopic referral centers, were retrospectively reviewed. RESULTS: A total of 40 patients were enrolled. TTS stent placement was successful in 39/40 patients (97.5%). 31 patients had an Ogilvie score of 4, nine an Ogilvie 3. After 2 weeks from stent placement 29 reported Ogilvie score of 0, eight a score of 1. None of the patients developed retrosternal pain requiring drugs. No patient experienced perforation, bleeding or migration. A total of seven patients (18%) developed dysphagia as late adverse event (AE). CONCLUSION: Through-the-scope ES presented less AEs, in terms of bleeding and perforation, if compared to the previous published data. An anti-migration system could be helpful, especially when the stent is placed for "ab-extrinseco" malignant dysphagia.


Subject(s)
Deglutition Disorders , Esophageal Neoplasms , Deglutition Disorders/etiology , Deglutition Disorders/surgery , Esophageal Neoplasms/complications , Esophageal Neoplasms/surgery , Humans , Palliative Care , Retrospective Studies , Stents , Treatment Outcome
14.
Gastrointest Endosc ; 89(1): 69-76, 2019 01.
Article in English | MEDLINE | ID: mdl-30189198

ABSTRACT

BACKGROUND AND AIMS: EUS-guided choledochoduodenostomy (EUS-CD) using a lumen-apposing metal stent (LAMS) has recently been reported as an alternative treatment approach for patients with malignant obstructive jaundice and failed ERCP. We analyzed the safety and technical and clinical efficacy of EUS-CD using LAMSs in patients with malignant obstructive jaundice. METHODS: This was a retrospective study of consecutive patients with inoperable malignant distal bile duct obstruction who underwent EUS-CD using an electrocautery-enhanced (EC)-LAMS over a 3-year period (2015-2018). The main outcome measures were technical and clinical success (defined as a decline in serum bilirubin level by 50% at 2-week follow-up). Secondary outcomes were occurrence of adverse events, procedure time, and stent patency. RESULTS: Forty-six patients (47.8% women; median age, 73.1 ± 12.6 years) underwent direct EUS-CD using the biliary EC-LAMS. The procedure was technically successful in 43 patients (93.5%). The rate of clinical success was 97.7%. Adverse events occurred in 5 (11.6%) patients and included the following: 1 fatal bleeding 17 days after stent placement, 3 episodes of stent occlusion (food impaction), and 1 spontaneous migration (all 4 requiring reintervention). The mean follow-up was 114.37 days (95% confidence interval, 73.2-155.4). CONCLUSIONS: EUS-CD using the EC-LAMS is effective. The rate of adverse events including one fatal event is not negligible and should be carefully considered before using the stent in this clinical setting. Prospective studies are required to validate our preliminary findings to fully assess the long-term efficacy and safety of the stent.


Subject(s)
Choledochostomy/methods , Cholestasis/surgery , Common Bile Duct/surgery , Self Expandable Metallic Stents , Aged , Aged, 80 and over , Ampulla of Vater , Bile Duct Neoplasms/complications , Cholangiocarcinoma/complications , Cholangiopancreatography, Endoscopic Retrograde , Cholestasis/etiology , Common Bile Duct Neoplasms/complications , Duodenal Neoplasms/complications , Electrocoagulation , Endosonography , Female , Humans , Jaundice, Obstructive , Male , Middle Aged , Pancreatic Neoplasms/complications , Postoperative Hemorrhage/epidemiology , Prosthesis Failure , Retrospective Studies , Stents , Surgery, Computer-Assisted , Treatment Failure , Treatment Outcome
16.
Dig Dis ; 37(4): 325-333, 2019.
Article in English | MEDLINE | ID: mdl-30897588

ABSTRACT

BACKGROUND: One of the controversial issues in the diagnosis of pancreatic neuroendocrine tumours (pNETs) is the accurate prediction of their clinical behaviour. OBJECTIVES: The aim of the study was to evaluate the role of endoscopic ultrasound (EUS) biopsy in the diagnosis and grading of pNETs in a certified ENETS Center. METHODS: A prospectively maintained database of EUS biopsy procedures was retrospectively reviewed to identify all consecutive patients referred to a certified ENETS Center with a suspicion of pNET between June 2014 and April 2017. The cytological and/or histological specimens were stained and the Ki-67 labeling index was evaluated. In patients undergoing surgery, the grade obtained with EUS-guided biopsy was compared with the final histological grade. The grade was evaluated according to the 2017 WHO classifications and grading. RESULTS: The study population included 59 patients. EUS biopsy material reached an adequacy of 98.3% and was adequate for Ki-67 evaluation in 84.7% of cases. Twenty-nine patients (49.2%) underwent surgery. Of these, 25 patients had Ki-67 evaluated on EUS biopsy: the agreement between EUS biopsy grading and surgical specimen grading was 84%. CONCLUSION: EUS biopsy is an accurate method for the diagnosis and grading of pNETs based on the WHO 2017 Ki-67 labelling scheme.


Subject(s)
Endoscopic Ultrasound-Guided Fine Needle Aspiration , Neuroendocrine Tumors/diagnostic imaging , Neuroendocrine Tumors/pathology , Pancreatic Neoplasms/diagnostic imaging , Pancreatic Neoplasms/pathology , World Health Organization , Female , Humans , Ki-67 Antigen/metabolism , Male , Middle Aged , Neoplasm Grading , Neuroendocrine Tumors/classification , Neuroendocrine Tumors/diagnosis , Pancreatic Neoplasms/classification , Pancreatic Neoplasms/diagnosis , Retrospective Studies
17.
Medicina (Kaunas) ; 55(10)2019 Sep 30.
Article in English | MEDLINE | ID: mdl-31575011

ABSTRACT

Background and Objectives: The aims of this study are to: describe the sociodemographic characteristics and typology of drug addiction among people who use drugs that attend the Servizio per le Dipendenze (SerD), and evaluate the competence and ability of these rehabilitation services to improve their health status and wellness. Materials and Methods: A cross-sectional study was conducted from January to July 2017. Patients attending two selected SerD facilities in the city of Naples, Italy were interviewed with a questionnaire gathering information on sociodemographic data, characteristics of drug addiction, characteristics of enrolment at the SerD, self-reported health status and wellness, and reports of the discrimination suffered. Results: Among the 451 people interviewed, 72.3% had started taking drugs by the age of 20, and half of them have used drugs within the last year. 54.5% of responders attended SerD for more than 10 years, and the two main reasons for attendance were to get help and to get methadone. 79.4% were declared to have a good/very good/excellent health status at the time of interviewing. 53.7% reported suffering from discrimination. Conclusions: Based on our study, discrimination is higher in participants who attended SerD for more than one year, who were formerly in prison, or who were current drug users.


Subject(s)
Healthcare Disparities , Substance-Related Disorders/epidemiology , Adult , Cross-Sectional Studies , Demography , Female , Health Status , Humans , Italy/epidemiology , Male , Middle Aged , Prevalence , Socioeconomic Factors , Substance-Related Disorders/prevention & control , Surveys and Questionnaires , Young Adult
18.
Gastrointest Endosc ; 87(6): 1464-1473, 2018 Jun.
Article in English | MEDLINE | ID: mdl-29329992

ABSTRACT

BACKGROUND AND AIMS: EUS elastography is useful in characterizing solid pancreatic lesions (SPLs), and fractal analysis-based technology has been used to evaluate geometric complexity in oncology. The aim of this study was to evaluate EUS elastography (strain ratio) and fractal analysis for the characterization of SPLs. METHODS: Consecutive patients with SPLs were prospectively enrolled between December 2015 and February 2017. Elastographic evaluation included parenchymal strain ratio (pSR) and wall strain ratio (wSR) and was performed with a new compact US processor. Elastographic images were analyzed using a computer program to determine the 3-dimensional histogram fractal dimension. A composite cytology/histology/clinical reference standard was used to assess sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating curve. RESULTS: Overall, 102 SPLs from 100 patients were studied. At final diagnosis, 69 (68%) were malignant and 33 benign. At elastography, both pSR and wSR appeared to be significantly higher in malignant as compared with benign SPLs (pSR, 24.5 vs 6.4 [P < .001]; wSR, 56.6 vs 15.3 [P < .001]). When the best cut-off levels of pSR and wSR at 9.10 and 16.2, respectively, were used, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating curve were 88.4%, 78.8%, 89.7%, 76.9%, and 86.7% and 91.3%, 69.7%, 86.5%, 80%, and 85.7%, respectively. Fractal analysis showed a significant statistical difference (P = .0087) between the mean surface fractal dimension of malignant lesions (D = 2.66 ± .01) versus neuroendocrine tumor (D = 2.73 ± .03) and a statistical difference for all 3 channels red, green, and blue (P < .0001). CONCLUSIONS: EUS elastography with pSR and fractal-based analysis are useful in characterizing SPLs. (Clinical trial registration number: NCT02855151.).


Subject(s)
Adenocarcinoma/diagnostic imaging , Elasticity Imaging Techniques , Endosonography , Fractals , Image Processing, Computer-Assisted , Neuroendocrine Tumors/diagnostic imaging , Pancreas/diagnostic imaging , Pancreatic Neoplasms/diagnostic imaging , Pancreatitis/diagnostic imaging , Aged , Breast Neoplasms/pathology , Female , Humans , Kidney Neoplasms/pathology , Logistic Models , Lung Neoplasms/pathology , Magnetic Resonance Imaging , Male , Middle Aged , Odds Ratio , Pancreatic Neoplasms/secondary , Positron-Emission Tomography , Prospective Studies , ROC Curve , Sensitivity and Specificity , Tomography, X-Ray Computed
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