scholarly journals A pilot study of novel duodenal covered self-expandable metal stent fixation

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yasuki Hori ◽  
Kazuki Hayashi ◽  
Itaru Naitoh ◽  
Katsuyuki Miyabe ◽  
Makoto Natsume ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Gastric Outlet Obstruction ◽  
Clinical Success ◽  
Performance Status ◽  
Outlet Obstruction ◽  
Poor Performance ◽  
Stent Migration ◽  
Poor Performance Status ◽  
Sems Placement

AbstractMigration of duodenal covered self-expandable metal stents (C-SEMSs) is the main cause of stent dysfunction in patients with malignant gastric outlet obstruction (mGOO). Because endoscopic SEMS placement is frequently selected in patients with poor performance status, we concurrently focused on the safety of the treatment. This pilot study included 15 consecutive patients with mGOO who underwent duodenal partially covered SEMS (PC-SEMS) placement with fixation using an over-the-scope-clip (OTSC). Technical feasibility, clinical success for oral intake estimated by the Gastric Outlet Obstruction Scoring System (GOOSS) score, and adverse events including stent migration were retrospectively assessed. All procedures were successful, and clinical success was achieved in 86.7% (13/15). Mean GOOSS scores were improved from 0.07 to 2.53 after the procedure (P < 0.001). Median survival time was 84 days, and all patients were followed up until death. Stent migration occurred in one case (6.7%) at day 17, which was successfully treated by removal of the migrated PC-SEMS using an enteroscope. For fixation using an OTSC, additional time required for the procedure was 8.9 ± 4.1 min and we did not observe OTSC-associated adverse events. Poor performance status was associated with clinical success (P = 0.03), but we could provide the treatment safely and reduce mGOO symptoms even in patients with poor performance status. In conclusion, duodenal PC-SEMS fixation using an OTSC is feasible for preventing stent migration in patients with mGOO including those with poor performance status.

Feasibility of Duodenal Covered Self-Expandable Metal Stent Fixation: A Pilot Study (With Video)

2021 ◽  
Author(s):  
Yasuki Hori ◽  
Kazuki Hayashi ◽  
Itaru Naitoh ◽  
Katsuyuki Miyabe ◽  
Makoto Natsume ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Gastric Outlet Obstruction ◽  
Clinical Success ◽  
Performance Status ◽  
Outlet Obstruction ◽  
Poor Performance ◽  
Stent Migration ◽  
Poor Performance Status ◽  
Sems Placement

Abstract Migration of duodenal covered self-expandable metal stents (C-SEMSs) is the main cause of stent dysfunction in patients with malignant gastric outlet obstruction (mGOO). Because endoscopic SEMS placement is frequently selected in patients with poor performance status, we concurrently focused on the safety of the treatment. This pilot study included 15 consecutive patients with mGOO who underwent duodenal C-SEMS placement with fixation using an over-the-scope-clip (OTSC). Technical feasibility, clinical success for oral intake estimated by the Gastric Outlet Obstruction Scoring System (GOOSS) score, and adverse events including stent migration were assessed. All procedures were successful, and clinical success was achieved in 86.7% (13/15). Mean GOOSS scores were improved from 0.07 to 2.53 after the procedure (P < 0.001). Stent migration occurred in one case (6.7%) with no other adverse events. For fixation using an OTSC, additional time required for the procedure was 8.9 ± 4.1 minutes. Poor performance status was associated with clinical success (P = 0.03), but we could provide the treatment safely and reduce mGOO symptoms even in patients with poor performance status. In conclusion, duodenal C-SEMS fixation using an OTSC is feasible for preventing stent migration in patients with mGOO including those with poor performance status.

Modified endoscopic ultrasound-guided double-balloon-occluded gastroenterostomy bypass (M-EPASS): a pilot study

Endoscopy ◽  
2021 ◽  
Author(s):  
Amanda Marino ◽  
Ali Bessissow ◽  
Corey Miller ◽  
David Valenti ◽  
Louis Boucher ◽  
...  
Keyword(s):  
Gastric Outlet Obstruction ◽  
Endoscopic Ultrasound ◽  
Clinical Success ◽  
Outlet Obstruction ◽  
Stent Migration ◽  
Stent Insertion ◽  
Ultrasound Guided ◽  
Double Balloon ◽  
Low Residue Diet ◽  
The Mean

Abstract Introduction We recently developed a double-balloon device, using widely available existing technology, to facilitate endoscopic ultrasound-guided gastroenterostomy (EUS-GE). Our aim is to assess the feasibility of this modified approach to EUS-guided double-balloon-occluded gastroenterostomy bypass (M-EPASS). Methods This was a single-center retrospective study of consecutive patients undergoing M-EPASS from January 2019 to August 2020. The double-balloon device consists of two vascular balloons that optimize the distension of a targeted small-bowel segment for EUS-guided stent insertion. The primary end point was the rate of technical success. Results 11 patients (45 % women; mean [standard deviation (SD)] age 64.9 [8.6]) with malignant gastric outlet obstruction were included. Technical and clinical success (ability to tolerate an oral diet) were achieved in 91 % (10/11) and 80 % (8/10) of patients, respectively. There was one adverse event (9 %) due to stent migration. Two patients (18 %) required re-intervention for stent obstruction secondary to food impaction. The mean (SD) time to a low residue diet was 3.5 (2.4) days. Conclusion M-EPASS appears to facilitate the technique of EUS-GE, potentially enhancing its safety and clinical adoption. Larger studies are needed to validate this innovative approach to gastric outlet obstruction.

FDA analysis of ECOG performance status and safety outcomes.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12024-12024 ◽  
Author(s):  
Harpreet Singh ◽  
Yutao Gong ◽  
Pourab Roy ◽  
Bellinda King-Kallimanis ◽  
Vishal Bhatnagar ◽  
...  
Keyword(s):  
Adverse Events ◽  
Disease Progression ◽  
Cumulative Incidence ◽  
Performance Status ◽  
Poor Performance ◽  
Treatment Discontinuation ◽  
Dropout Rates ◽  
Poor Performance Status ◽  
Ecog Performance Status ◽  
Eligibility Criteria

12024 Background: Patients with poor performance status are often excluded from clinical trials. The FDA has published several guidances on modernizing oncology clinical trial eligibility criteria to more accurately reflect the patient population. Many patients receiving novel oncology therapeutics are heavily pretreated, and often have comorbidities, organ dysfunction, and frailty syndromes. Little is known about the safety of novel therapeutics in patients with poor performance status. Methods: Data from six randomized trials (n=4465) leading to registration for several solid tumor and malignant hematologic cancers, including multiple therapeutic mechanisms of action, such as EGFR TKI’s, immune checkpoint inhibitors (ICI), and chemotherapy, were pooled. Cumulative incidence of Grade 3-5 adverse events and serious adverse events at Days 30, 90, and 180 were evaluated based on ECOG 0-2. Rates of treatment discontinuation by ECOG was also examined. Results: Cumulative incidence of toxicity events at days 30, 90, and 180 are shown in Table. Patient dropout rates due to death were 3.9%, 6.7%, and 10.9%; dropout rates due to disease progression were 66.5%, 66.6% and 56.9%; and dropout rates due to reasons other than progression or death were 29.7%, 26.7% and 32.1% for ECOG PS 0, 1 and 2, respectively. Conclusions: This FDA exploratory analysis of safety outcomes in registration trials based on ECOG suggests increasing rates of adverse events and rates of treatment discontinuation due to death with worsening performance status. Discontinuation rates due to disease progression and other reasons did not appear to be worse for ECOG 2 compared to 0-1. These findings were consistent across therapies (targeted therapy, ICI, chemotherapy). All trials in the analysis led to FDA approval, thus inclusion of patients with ECOG 2 did not adversely affect the trial outcome for this set of FDA approved agents. ECOG performance status eligibility criteria should be evaluated and modified on a frequent basis during drug development. Additional analysis of trials which enroll patients with ECOG 2 is needed. [Table: see text]

Clinical outcomes in patients undergoing multiple self-expandable metallic stent placement by stent in stent technique for malignant gastric outlet obstruction.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 88-88
Author(s):  
Jinwon MO ◽  
Jie-Hyun Kim ◽  
Seung Yong Shin ◽  
Da Hyun Jung ◽  
Jae Jun Park ◽  
...  
Keyword(s):  
Gastric Outlet Obstruction ◽  
Stent Placement ◽  
Clinical Success ◽  
Outlet Obstruction ◽  
Metallic Stent ◽  
Sems Placement ◽  
Stent Patency ◽  
Malignant Gastric Outlet Obstruction ◽  
The Third ◽  
Expandable Metallic Stent

88 Background: Self-expandable metallic stent (SEMS) placement is widely used for relieving the obstructive symptoms of malignant gastric outlet obstruction (MGOO). The aims were to evaluate the efficacy and safety of multiple gastroduodenal stent placement by stent in stent technique and identify predictive factors about stent patency. Methods: We retrospectively analyzed data from 170 patients with GOO receiving SEMS by stent in stent technique from July 2006 to July 2018. Among them, 90 patients had been treated with gastroduodenal SEMS placement for MGOO. Technical and clinical success rates were evaluated. And, clinical outcomes with predictors of stent patency were also analyzed. Results: Among the subjects, 34.4% were treated with secondary SEMS placement, and 9.7% were treated with third SEMS placement because of the previous stent dysfunction. The median stent patency time was 15.7 weeks (range 0-89) in the first SEMS, 10.4 weeks (range 0-44) in the second SEMS, and 11.3 weeks (range 1-29) in the third SEMS. The technical and clinical success rate were 100% and 97.8% in the first SEMS, 100% and 90.3% in the second SEMS, 100% and 100% in the third SEMS. In multivariable analysis, the first SEMS placement of covered type including Comvi stent was correlated with prolonged stent patency (OR 4.549, P = 0.001). And both chemotherapy after the first SEMS placement (OR 8.248, P = 0.006) and chemotherapy after the second SEMS placement (OR 7.467, P = 0.003) were correlated with prolonged stent patency. Serious complications such as gastrointestinal hemorrhage or perforation did not occur in any patient. Conclusions: Secondary and third gastroduodenal SEMS placement by stent in stent technique is a safe and effective treatment for the first stent dysfunction in MGOO. The stent placement of covered type and chemotherapy after stent placement is the predictor of stent patency. Keywords: Malignant gastric outlet obstruction, Self-expandable metallic stent, Stent in stent technique, Stent patency, Predictive factor

scholarly journals Gastric outlet obstruction with ascites: EUS-guided gastro-enterostomy is feasible

2021 ◽  
Vol 09 (12) ◽  
pp. E1918-E1923
Author(s):  
Jahangeer Basha ◽  
Sundeep Lakhtakia ◽  
Raghavendra Yarlagadda ◽  
Zaheer Nabi ◽  
Rajesh Gupta ◽  
...  
Keyword(s):  
Adverse Events ◽  
Gastric Outlet Obstruction ◽  
Clinical Success ◽  
Outlet Obstruction ◽  
Survival Times ◽  
Technical Success ◽  
Ultrasound Guided ◽  
Underlying Malignancy ◽  
Study Population ◽  
Free Hand Technique

Abstract Background and study aims Endoscopic ultrasound-guided gastro-enterostomy(EUS-GE) is a recently described novel minimally invasive endoscopic procedure for patients having malignant gastric outlet obstruction (GOO). The safety of EUS-GE in the presence of ascites with GOO is not known. The objective of the study was to evaluate the feasibility and safety of EUS-GE in patients with GOO and ascites. Patients and methods Consecutive patients with GOO who underwent EUS-GE between January 2019 and March 2021 constituted the study population. EUS-GE was performed using either EPASS or free-hand technique. The technical success, clinical success, adverse events, and survival times were evaluated. The outcomes were compared between patients with and without ascites. Results A total of 31 patients with GOO underwent EUS-GE of whom 29 (93.5 %) had malignant and two (6.4 %) had benign etiologies. Ascites was observed in 12 out of 31 (38.7%) patients and all had underlying malignancy. Majority (27, 87 %) of the EUS-GE procedures were performed using EPASS technique, and 4 (13 %) underwent free-hand technique. Eleven of 12 patients with ascites and GOO underwent EUS GE using EPASS technique. The technical success (91.6 % vs. 89.4 %; P = 0.841), clinical success (83.3 % vs. 89.4 %; P = 0.619), mean procedure time (32 vs. 31.6 min; P = 0.968) and adverse events (0 % vs. 10.5 %; P = 0.245) were not significantly different between patients with or without ascites. However, the median survival time was significantly low in patients with ascites when compared to without ascites (36 vs. 290 days; P < 001). Conclusions Ascites is a common occurrence in patients with malignant GOO. EUS GE is feasible in presence of ascites with EPASS technique.

scholarly journals Antroduodenal Stenting for Malignant Gastric Outlet Obstruction: Technique and Outcome

2019 ◽  
Vol 10 (01) ◽  
pp. 021-027
Author(s):  
Uday C. Ghoshal ◽  
Vinay Kumar
Keyword(s):  
Gastric Outlet Obstruction ◽  
Stent Placement ◽  
Clinical Success ◽  
Outlet Obstruction ◽  
Stent Migration ◽  
Severe Malnutrition ◽  
Success Rates ◽  
Stent Occlusion ◽  
Endoscopic Stent ◽  
Presenting Symptoms

ABSTRACTGastric outlet obstruction (GOO) is usually a late presentation of gastric cancer, pancreaticobiliary malignancy, and extrinsic lymph nodal compression. Presenting symptoms are abdominal pain, postprandial epigastric fullness, and recurrent vomiting, which lead to severe malnutrition and dehydration and poor quality of life (QoL). Endoscopic enteral stent placement has become the acceptable alternative modality for palliation of malignant GOO because it is safe, minimally invasive, and a cost-effective procedure. In addition, endoscopic stent placement leads to shorter time to resume oral diet and shorter hospital stay in comparison to surgical bypass. Endoscopic stent placement is associated with high technical as well as clinical success rates and improvement in QoL, but no survival improvement. Recurrence of symptoms occurs due to stent occlusion, or stent migration, which can be successfully managed with repeat endoscopic stent placement. Perforation and bleeding are serious but rare complications.

scholarly journals EUS-guided gastroenterostomy: Initial experience in a brazilian tertiary center

2020 ◽  
Vol 66 (11) ◽  
pp. 1521-1525
Author(s):  
Joel Fernandez de Oliveira ◽  
Martin Andres Coronel Cordero ◽  
Gustavo Rosa de Almeida Lima ◽  
Gustavo Andrade de Paulo ◽  
Marcelo Simas de Lima ◽  
...  
Keyword(s):  
Adverse Events ◽  
Gastric Outlet Obstruction ◽  
Clinical Success ◽  
Outlet Obstruction ◽  
Initial Experience ◽  
Technical Success ◽  
Malignant Gastric Outlet Obstruction ◽  
Soft Diet ◽  
Tertiary Center ◽  
Promising Treatment

SUMMARY INTRODUCTION: EUS-guided gastroenterostomy (EUS-GE) is a novel procedure for palliation of malignant gastric outlet obstruction (GOO). Our aim was to evaluate the outcomes of this technique in our initial experience. METHODS: Patients with GOO from our institute were included. Technical success was defined as the successful creation of a gastroenterostomy. Clinical success was defined as the ability to tolerate a soft diet after the procedure. We assessed adverse events and diet tolerance 1 month after the procedure. RESULTS: Three patients were included. Technical and clinical success was achieved in all cases. There were no adverse events and good diet tolerance was observed 1 month after the procedure in the included patients. CONCLUSION: EUS-GE is a promising treatment for patients with GOO.

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