Multisegmented esophageal fully covered self-expandable metal stent for palliation of malignant dysphagia:a prospective, multicenter feasibility and safety study

Background and Aims: A novel multisegmented esophageal fully covered self-expandable metal stent (FCSEMS) was designed to reduce stent migration, which is seen in up to 30% of patients. The goal of this study was to evaluate the safety and efficacy of the multisegmented FCSEMS. Methods: This multicenter prospective study aimed to include 30 patients undergoing palliative stent placement. Efficacy, defined as technically successful stent placement and dysphagia scores, and safety, defined as the number of adverse events (AEs) and serious AEs (SAEs), were measured. Results: The study was prematurely terminated due to safety concerns after including 23 patients (mean ± standard deviation age, 72 ± 10 years; 78% male). Stent placement was technically successful in 21 patients (91%), and dysphagia scores had improved in all patients with successful stent placement. SAEs were reported in 16 (70%) patients. Stent-related mortality occurred in 3 patients (13%). Conclusions: The multisegmented FCSEMS successfully treated malignant dysphagia. The study was prematurely terminated, however, because stent placement was associated with a relatively high SAE rate. (Clinical trial registration number: NCT04415463.)</p

Multisegmented esophageal fully covered self-expandable metal stent for palliation of malignant dysphagia:a prospective, multicenter feasibility and safety study

Background and Aims: A novel multisegmented esophageal fully covered self-expandable metal stent (FCSEMS) was designed to reduce stent migration, which is seen in up to 30% of patients. The goal of this study was to evaluate the safety and efficacy of the multisegmented FCSEMS. Methods: This multicenter prospective study aimed to include 30 patients undergoing palliative stent placement. Efficacy, defined as technically successful stent placement and dysphagia scores, and safety, defined as the number of adverse events (AEs) and serious AEs (SAEs), were measured. Results: The study was prematurely terminated due to safety concerns after including 23 patients (mean ± standard deviation age, 72 ± 10 years; 78% male). Stent placement was technically successful in 21 patients (91%), and dysphagia scores had improved in all patients with successful stent placement. SAEs were reported in 16 (70%) patients. Stent-related mortality occurred in 3 patients (13%). Conclusions: The multisegmented FCSEMS successfully treated malignant dysphagia. The study was prematurely terminated, however, because stent placement was associated with a relatively high SAE rate. (Clinical trial registration number: NCT04415463.)</p

An 8-gene mRNA expression profile in circulating tumor cells predicts response to aromatase inhibitors in metastatic breast cancer patients

Background: Molecular characterization of circulating tumor cells (CTC) is promising for personalized medicine. We aimed to identify a CTC gene expression profile predicting outcome to first-line aromatase inhibitors in metastatic breast cancer (MBC) patients. Methods: CTCs were isolated from 78 MBC patients before treatment start. mRNA expression levels of 96 genes were measured by quantitative reverse transcriptase polymerase chain reaction. After applying predefined exclusion criteria based on lack of sufficient RNA quality and/or quantity, the data from 45 patients were used to construct a gene expression profile to predict poor responding patients, defined as disease progression or death <9 months, by a leave-one-out cross validation. Results: Of the 45 patients, 19 were clinically classified as poor responders. To identify them, the 75 % most variable genes were used to select genes differentially expressed between good and poor responders. An 8-gene CTC predictor was significantly associated with outcome (Hazard Ratio [HR] 4.40, 95 % Confidence Interval [CI]: 2.17-8.92, P < 0.001). This predictor identified poor responding patients with a sensitivity of 63 % and a positive predictive value of 75 %, while good responding patients were correctly predicted in 85 % of the cases. In multivariate Cox regression analysis, including CTC count at baseline, the 8-gene CTC predictor was the only factor independently associated with outcome (HR 4.59 [95 % CI: 2.11-9.56], P < 0.001). This 8-gene signature was not associated with outcome in a group of 71 MBC patients treated with systemic treatments other than AI. Conclusions: An 8-gene CTC predictor was identified which discriminates good and poor outcome to first-line aromatase inhibitors in MBC patients. Although results need to be validated, this study underscores the potential of molecular characterization of CTCs

Prevalence of neoplasia at colonoscopy among testicular cancer survivors treated with platinum-based chemotherapy

Testicular cancer survivors (TCS) treated with platinum-based chemotherapy have an increased risk of colorectal cancer (CRC). We determined the yield of colonoscopy in TCS to assess its potential in reducing CRC incidence and mortality. We conducted a colonoscopy screening study among TCS in four Dutch hospitals to assess the yield of colorectal neoplasia. Neoplasia was defined as adenomas, serrated polyps (SPs), advanced adenomas (AAs: ≥10 mm diameter, high-grade dysplasia or ≥25% villous component), advanced serrated polyps (ASPs: ≥10 mm diameter or dysplasia) or CRC. Advanced neoplasia (AN) was defined as AA, ASP or CRC. Colonoscopy yield was compared to average-risk American males who underwent screening colonoscopy (n = 24,193) using a propensity score matched analysis, adjusted for age, smoking status, alcohol consumption and body mass index. A total of 137 TCS underwent colonoscopy. Median age was 50 years among TCS (IQR 43–57) vs 55 years (IQR 51–62) among American controls. A total of 126 TCS were matched to 602 controls. The prevalence of AN was higher in TCS than in controls (8.7% vs 1.7%; P =.0002). Nonadvanced adenomas and SPs were detected in 45.2% of TCS vs 5.5% of controls (P &lt;.0001). No lesions were detected in 46.0% of TCS vs 92.9% of controls (P &lt;.0001). TCS treated with platinum-based chemotherapy have a higher prevalence of neoplasia and AN than matched controls. These results support our hypothesis that platinum-based chemotherapy increases the risk of colorectal neoplasia in TCS. Cost-effectiveness studies are warranted to ascertain the threshold of AN prevalence that justifies the recommendation of colonoscopy for TCS.</p

Prevalence of neoplasia at colonoscopy among testicular cancer survivors treated with platinum-based chemotherapy

Testicular cancer survivors (TCS) treated with platinum-based chemotherapy have an increased risk of colorectal cancer (CRC). We determined the yield of colonoscopy in TCS to assess its potential in reducing CRC incidence and mortality. We conducted a colonoscopy screening study among TCS in four Dutch hospitals to assess the yield of colorectal neoplasia. Neoplasia was defined as adenomas, serrated polyps (SPs), advanced adenomas (AAs: ≥10 mm diameter, high-grade dysplasia or ≥25% villous component), advanced serrated polyps (ASPs: ≥10 mm diameter or dysplasia) or CRC. Advanced neoplasia (AN) was defined as AA, ASP or CRC. Colonoscopy yield was compared to average-risk American males who underwent screening colonoscopy (n = 24,193) using a propensity score matched analysis, adjusted for age, smoking status, alcohol consumption and body mass index. A total of 137 TCS underwent colonoscopy. Median age was 50 years among TCS (IQR 43–57) vs 55 years (IQR 51–62) among American controls. A total of 126 TCS were matched to 602 controls. The prevalence of AN was higher in TCS than in controls (8.7% vs 1.7%; P =.0002). Nonadvanced adenomas and SPs were detected in 45.2% of TCS vs 5.5% of controls (P &lt;.0001). No lesions were detected in 46.0% of TCS vs 92.9% of controls (P &lt;.0001). TCS treated with platinum-based chemotherapy have a higher prevalence of neoplasia and AN than matched controls. These results support our hypothesis that platinum-based chemotherapy increases the risk of colorectal neoplasia in TCS. Cost-effectiveness studies are warranted to ascertain the threshold of AN prevalence that justifies the recommendation of colonoscopy for TCS.</p

Prevalence of neoplasia at colonoscopy among testicular cancer survivors treated with platinum-based chemotherapy

Testicular cancer survivors (TCS) treated with platinum-based chemotherapy have an increased risk of colorectal cancer (CRC). We determined the yield of colonoscopy in TCS to assess its potential in reducing CRC incidence and mortality. We conducted a colonoscopy screening study among TCS in four Dutch hospitals to assess the yield of colorectal neoplasia. Neoplasia was defined as adenomas, serrated polyps (SPs), advanced adenomas (AAs: ≥10 mm diameter, high-grade dysplasia or ≥25% villous component), advanced serrated polyps (ASPs: ≥10 mm diameter or dysplasia) or CRC. Advanced neoplasia (AN) was defined as AA, ASP or CRC. Colonoscopy yield was compared to average-risk American males who underwent screening colonoscopy (n = 24,193) using a propensity score matched analysis, adjusted for age, smoking status, alcohol consumption and body mass index. A total of 137 TCS underwent colonoscopy. Median age was 50 years among TCS (IQR 43-57) vs 55 years (IQR 51-62) among American controls. A total of 126 TCS were matched to 602 controls. The prevalence of AN was higher in TCS than in controls (8.7% vs 1.7%; P = .0002). Nonadvanced adenomas and SPs were detected in 45.2% of TCS vs 5.5% of controls (P < .0001). No lesions were detected in 46.0% of TCS vs 92.9% of controls (P < .0001). TCS treated with platinum-based chemotherapy have a higher prevalence of neoplasia and AN than matched controls. These results support our hypothesis that platinum-based chemotherapy increases the risk of colorectal neoplasia in TCS. Cost-effectiveness studies are warranted to ascertain the threshold of AN prevalence that justifies the recommendation of colonoscopy for TCS

New insights of stent placements for malignant upper gastrointestinal cancers

Palliative care for patients with incurable esophageal cancer aims to alleviate symptoms to improve their quality of life. A commonly method involves the placement of self-expanding metal stents to enhance food passage. While this approach is generally effective, complications may arise, often necessitating additional endoscopic interventions and potentially impacting patients' quality of life. This thesis seeks to offer new insights into stent placement as a palliative treatment and provide an understanding of complications post-stent placement.The thesis commences with a comprehensive overview of the literature on palliation of dysphagia in patients with esophageal cancer. For patients with a life expectancy fewer than three months, esophageal stent placement is recommended due to its rapid relief of dysphagia. Although brachytherapy has traditionally been the recommended treatment for patients with a life expectancy of over three months, recent data suggest that external radiotherapy could be an effective and safe alternative.New oncological treatments and improvements in patient survival might influence the response and outcome of self-expanding metal stent placement. These changes are analyzed in a retrospective study spanning 23 years. Despite the introduction of new esophageal stent designs, the number of patients experiencing renewed dysphagia after stent placement did not decrease. However, the incidence of severe complications decreased. One of the most disruptive symptoms in cancer patients is pain. Sixty percent of patients experienced significant pain immediately after esophageal stent placement, and over 30% still required opioids two weeks after the procedure. There is no difference between fully covered and partially covered esophageal stents concerning complications and recurrence of dysphagia.The thesis closed with the clinical outcomes of placing duodenal stents for malignant conditions over a 20-year period. Over time, total survival decreased, and more than half of the patients experienced symptom recurrence after duodenal stent placement.<br/

New insights of stent placements for malignant upper gastrointestinal cancers

Palliative care for patients with incurable esophageal cancer aims to alleviate symptoms to improve their quality of life. A commonly method involves the placement of self-expanding metal stents to enhance food passage. While this approach is generally effective, complications may arise, often necessitating additional endoscopic interventions and potentially impacting patients' quality of life. This thesis seeks to offer new insights into stent placement as a palliative treatment and provide an understanding of complications post-stent placement.The thesis commences with a comprehensive overview of the literature on palliation of dysphagia in patients with esophageal cancer. For patients with a life expectancy fewer than three months, esophageal stent placement is recommended due to its rapid relief of dysphagia. Although brachytherapy has traditionally been the recommended treatment for patients with a life expectancy of over three months, recent data suggest that external radiotherapy could be an effective and safe alternative.New oncological treatments and improvements in patient survival might influence the response and outcome of self-expanding metal stent placement. These changes are analyzed in a retrospective study spanning 23 years. Despite the introduction of new esophageal stent designs, the number of patients experiencing renewed dysphagia after stent placement did not decrease. However, the incidence of severe complications decreased. One of the most disruptive symptoms in cancer patients is pain. Sixty percent of patients experienced significant pain immediately after esophageal stent placement, and over 30% still required opioids two weeks after the procedure. There is no difference between fully covered and partially covered esophageal stents concerning complications and recurrence of dysphagia.The thesis closed with the clinical outcomes of placing duodenal stents for malignant conditions over a 20-year period. Over time, total survival decreased, and more than half of the patients experienced symptom recurrence after duodenal stent placement.<br/

Early pain detection and management after esophageal metal stent placement in incurable cancer patients : A prospective observational cohort study

BACKGROUND AND STUDY AIMS: Studies of esophageal self-expandable metal stents (SEMS) mainly focus on efficacy and recurrent dysphagia. Retrosternal pain has been described in up to 14 % of these patients, however, prospective daily pain assessment has not yet been performed. We conducted a prospective study to evaluate the occurrence and management of pain after esophageal SEMS deployment. PATIENTS AND METHODS: A total of 65 patients who underwent SEMS placement for incurable malignant esophageal stenosis were included. Patients used a diary to record intensity of pain twice daily for 2 weeks, according to the Numeric Rating Scale (NRS). A pain score ≥ 4 was used to determine whether patients experienced significant pain. If pain occurred, acetaminophen was used and, in cases of ongoing pain, an opiate was prescribed. Dose, duration, and kind of analgesic were noted. RESULTS: The rate of significant pain increased from 0 % at baseline to 60 % on Day 1 (P < 0.001), followed by 37 % and 25 % on Days 7 and 14, respectively. The rate of analgesics use increased from 20 % at baseline to 78 % on Day 1 (P < 0.001), followed by 72 % and 62 % on Days 7 and 14, respectively. The use of opiates increased from 14 % at baseline to 42 % on Day 1 (P < 0.001). No variables associated with SEMS related pain were found. CONCLUSIONS: Two-thirds of patients experience significant pain after esophageal SEMS insertion and analgesics, including opiates, are frequently required. Patients need to be informed and preventive prescription of analgesia should be considered in order to improve quality of life

Early pain detection and management after esophageal metal stent placement in incurable cancer patients : A prospective observational cohort study

BACKGROUND AND STUDY AIMS: Studies of esophageal self-expandable metal stents (SEMS) mainly focus on efficacy and recurrent dysphagia. Retrosternal pain has been described in up to 14 % of these patients, however, prospective daily pain assessment has not yet been performed. We conducted a prospective study to evaluate the occurrence and management of pain after esophageal SEMS deployment. PATIENTS AND METHODS: A total of 65 patients who underwent SEMS placement for incurable malignant esophageal stenosis were included. Patients used a diary to record intensity of pain twice daily for 2 weeks, according to the Numeric Rating Scale (NRS). A pain score ≥ 4 was used to determine whether patients experienced significant pain. If pain occurred, acetaminophen was used and, in cases of ongoing pain, an opiate was prescribed. Dose, duration, and kind of analgesic were noted. RESULTS: The rate of significant pain increased from 0 % at baseline to 60 % on Day 1 (P < 0.001), followed by 37 % and 25 % on Days 7 and 14, respectively. The rate of analgesics use increased from 20 % at baseline to 78 % on Day 1 (P < 0.001), followed by 72 % and 62 % on Days 7 and 14, respectively. The use of opiates increased from 14 % at baseline to 42 % on Day 1 (P < 0.001). No variables associated with SEMS related pain were found. CONCLUSIONS: Two-thirds of patients experience significant pain after esophageal SEMS insertion and analgesics, including opiates, are frequently required. Patients need to be informed and preventive prescription of analgesia should be considered in order to improve quality of life