Surgical Outcomes in Patients With Malignant Small Bowel Obstruction: A National Cohort Study.

OBJECTIVE: The study objectives were to characterize surgical outcomes for malignant small bowel obstruction (MaSBO) as compared to other small bowel obstructions (SBO) and to develop a prediction model for postoperative mortality for MaSBO. SUMMARY BACKGROUND DATA: MaSBO is a morbid complication of advanced cancers for which the optimal management remains undefined. METHODS: Patients who underwent surgery for MaSBO or SBO were identified from the National Surgical Quality Improvement Program (2005-2017). Outcomes [30-day morbidity, unplanned readmissions, mortality, postoperative length of stay (LOS)] were compared between propensity score-matched MaSBO and SBO patients. An internally validated prediction model for mortality in MaSBO patients was developed. RESULTS: Of 46,706 patients, 1612 (3.5%) had MaSBO. Although MaSBO patients were younger than those with SBO (median 63 vs 65 years, P < 0.001), they were otherwise more clinically complex, including a higher proportion with recent weight loss (22.0% vs 4.0%, P < 0.001), severe hypoalbuminemia (18.6% vs 5.2%, P < 0.001), and cytopenias. After matching (N = 1609/group), MaSBO was associated with increased morbidity [odds ratio (OR) 1.2, P = 0.004], but not readmission (OR 1.1, P = 0.48) or LOS (incidence rate ratio 1.0, P = 0.14). The odds of mortality were significantly higher for MaSBO than SBO (OR 3.3, P < 0.001). A risk-score model predicted postoperative mortality for MaSBO with an optimism-adjusted Brier score of 0.114 and area under the curve of 0.735. Patients in the highest-risk category (11.5% of MaSBO population) had a predicted mortality rate of 39.4%. CONCLUSION: Surgery for MaSBO is associated with substantial morbidity and mortality, necessitating careful patient evaluation before operative intervention.

Adverse effects of cell-free and concentrated ascites reinfusion therapy for malignant ascites: a single-institute experience.

BACKGROUND: Cell-free and concentrated ascites reinfusion therapy (CART) is a strategy for improving various intractable symptoms due to refractory ascites, including hypoalbuminemia. CART has recently been applied in the treatment of cancer patients. This study was performed to assess the safety of CART in a single cancer institute. METHODS: We retrospectively reviewed 233 CART procedures that were performed for 132 cancer patients in our institute. RESULTS: The median weight of ascites before and after concentration was 4,720 g and 490 g (median concentration rate, 10.0-fold), The median amounts of total protein and albumin were 64.0 g and 32.6 g (median recovery rates, 44.9% and 49.0%), respectively. Thirty-three adverse events (AEs) were observed in 22 (9.4%) of 233 procedures; 30 of these events occurred after reinfusion. The most common reinfusion-related AEs were fever (13 events) and chills (10 events). Univariate analyses revealed no significant relationships between the frequency of AEs and age, sex, appearance of ascites, weight of harvested and concentrated ascites, the ascites processing rate (filtration and concentration), weight of saline used for membrane cleaning, amount of calculated total protein for infusion, or prophylaxis against AEs; the reinfusion rate of ≥ 125 mL/h or ≥ 10.9 g/h of total protein affected the frequency of AEs, regardless of the prophylactic use of steroids. CONCLUSIONS: The observed AEs were mainly mild reactions after reinfusion, which were related to a reinfusion rate of volume ≥ 125 mL/h, a simple indicator in practice, or total protein ≥ 10.9 g/h. Although our study was retrospective in nature and undertaken in a single institute, this information may be helpful for the management of cancer patients with refractory malignant ascites using CART.

Feasibility of a fast-track randomized controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with refractory malignant ascites.

BACKGROUND: Malignant ascites often causes discomfort in advanced cancer patients. Paracentesis is the most common treatment modality, but it requires frequently repeated treatment. Cell-free and concentrated ascites reinfusion therapy (CART) may prolong the paracentesis interval, but controlled trials are lacking. We assessed the feasibility of a randomized controlled trial of CART vs. paracentesis alone for patients with refractory malignant ascites. METHODS: This study was an open-label, fast-track, randomized controlled, feasibility trial. Patients admitted to four designated cancer hospitals who received no further anticancer treatments were eligible. Patients were randomly assigned 1:1 to a CART arm or control (simple paracentesis) arm. The feasibility endpoint was the percentage of patients who completed the study intervention. Secondary endpoints included paracentesis-free survival, patient's request on the questionnaire for paracentesis (PRO-paracentesis)-free survival (the period until the patients first reported that they would want paracentesis if indicated), and adverse events. RESULTS: We screened 953 patients for eligibility. Of 61 patients with refractory malignant ascites, 21 patients were determined as eligible. Finally, 20 patients consented and were allocated; 18 patients (90%, 95% CI: 68.3-98.8) completed the study intervention. All patients had an ECOG performance status of 3 or 4. The median drained ascites volume was 3,200 mL in the CART arm and 2,500 mL in the control arm. In the CART arm, the median reinfused albumin volume was 12.6 g. Median paracentesis-free survivals were 5 days (95% CI: 2-6) in the CART arm, and 6 days (3-9) in the control arm. Median PRO-paracentesis-free survivals were 4 days (2-5) and 5 days (1-9), respectively. A total of 73% of patients received paracentesis within 2 days from their first request for the next paracentesis. One patient in the CART arm developed Grade 1 fever. CONCLUSIONS: A fast-track randomized controlled trial of CART for patients with malignant ascites is feasible. The efficacy and safety of CART should be assessed in future trials. PRO-paracentesis-free survival may be a complementary outcome measure with paracentesis-free survival in future trials. TRIAL REGISTRATION: Registered at University Hospital Medical Information Network Clinical Trial Registry as UMIN000031029 . Registered on 28/01/2018.

Endoscopic placement of covered versus uncovered self-expandable metal stents for palliation of malignant gastric outlet obstruction.

OBJECTIVE: Stenting is an established endoscopic therapy for malignant gastric outlet obstruction (mGOO). The choice of stent (covered vs uncovered) has been examined in prior randomised studies without clear results. DESIGN: In a multicentre randomised prospective study, we compared covered (CSEMS) with uncovered self-expandable metal stents (UCSEMS) in patients with mGOO; main outcomes were stent dysfunction and patient survival, with subgroup analyses of patients with extrinsic and intrinsic tumours. RESULTS: Overall survival was poor with no difference between groups (probability at 3 months 49.7% for covered vs 48.4% for uncovered stents; log-rank for overall survival p=0.26). Within that setting of short survival, the proportion of stent dysfunction was significantly higher for uncovered stents (35.2% vs 23.4%, p=0.01) with significantly shorter time to stent dysfunction. This was mainly relevant for patients with extrinsic tumours (stent dysfunction rates for uncovered stents 35.6% vs 17.5%, p<0.01). Subgrouping was also relevant with respect to tumour ingrowth (lower with covered stents for intrinsic tumours; 1.6% vs 27.7%, p<0.01) and stent migration (higher with covered stents for extrinsic tumours: 15.3% vs 2.5%, p<0.01). CONCLUSIONS: Due to poor patient survival, minor differences between covered and uncovered stents may be less relevant even if statistically significant; however, subgroup analysis would suggest to use covered stents for intrinsic and uncovered stents for extrinsic malignancies.

Covered versus uncovered metal stents for malignant gastric outlet obstruction: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Self-expandable metal stents (SEMSs) are used for palliation of malignant gastric outlet obstruction (GOO). Studies comparing covered SEMSs (C-SEMSs) and uncovered SEMSs (U-SEMSs) have led to inconclusive results. We compared efficacy and safety of C-SEMSs versus U-SEMSs in patients with GOO. METHODS: We searched MEDLINE, EMBASE, and Cochrane Library from 2000 to 2019 to identify available studies comparing C-SEMSs versus U-SEMSs in patients with GOO. Primary outcomes were stent survival and patient survival, whereas secondary outcomes were clinical and technical success, Gastric Outlet Obstruction Score System (GOOSS) score after the procedure, overall adverse events, reintervention rate, dysfunction rate, stent occlusion, and stent migration. RESULTS: Overall, 7 randomized controlled trials and 9 observational studies were identified that included 1741 patients. C-SEMSs were associated with higher stent survival (hazard ratio, .68; 95% confidence interval [CI], .48-.96), whereas patient survival did not statistically significantly differ between C-SEMS and U-SEMS groups (hazard ratio, .96; 95% CI, .75-1.23). Clinical and technical success were not statistically different between groups (odds ratios, 1.1 [95% CI, .76-1.61] and .69 [95% CI, .21-2.3], respectively). There were no differences in terms of overall adverse events, reintervention rate, dysfunction rate, and GOOSS rate ≥2 after SEMS placement. U-SEMSs were associated with a higher rate of occlusion (odds ratio, .34; 95% CI, .21-.53) and C-SEMSs with a higher rate of migration (odds ratio, 4.28; 95% CI, 2.79-6.57). CONCLUSIONS: C-SEMSs were associated with higher stent survival (time between stent deployment and stent dysfunction) compared with U-SEMSs, whereas no differences in terms of patient survival (time between stent deployment and patient's death) emerged. However, U-SEMSs were associated with higher risk of occlusion and C-SEMSs with higher risk of migration. Further studies using new C-SEMSs with an antimigration system are needed.

Peritoneal Carcinomatosis in Gastro-Entero-Pancreatic Neuroendocrine Neoplasms: Clinical Impact and Effectiveness of the Available Therapeutic Options.

BACKGROUND: Peritoneal carcinomatosis (PC) can affect the quality of life of patients with gastro-entero-pancreatic neuroendocrine neoplasms (GEP-NENs). Peritoneal disease control by medical therapies in these patients has been poorly investigated Objectives: To describe, in a consecutive series of GEP-NENs, the clinical impact of PC and to report the effectiveness of available treatments in PC control. METHODS: A retrospective, monocenter analysis was performed of 135 GEP-NENs (1993-2016) with at least a 12-month follow-up. Peritoneal disease progression was defined as detection of a significant increase in size or appearance of new implants by imaging. RESULTS: A total of 62.9% of cases had diffuse PC (involving at least 2 abdominal quadrants). According to WHO 2017 classification, cases were 42.3% neuroendocrine tumors NET-G1, 45.5% NET-G2, 6.5% NET-G3, 4.9% neuroendocrine carcinomas NEC-G3, and 0.8% mixed neuroendocrine-nonneuroendocrine neoplasms. Bowel obstruction occurred in 30 (22.2%) patients mainly depending on size of peritoneal implants (HR: 1.10; 95% CI: 1.02-1.20; p = 0.01). Patients with diffuse PC treated with peptide receptor radionuclide therapy (PRRT) showed peritoneal progression in 37.5% of cases, and bowel obstruction or ascites in 28.1%. Better peritoneal disease control was observed in cases receiving somatostatin analogs at first-line therapy, probably due to a less aggressive disease behavior for these patients. CONCLUSIONS: Bowel obstruction is not uncommon in GEP-NENs with PC. PRRT should be adopted with caution in GEP-NENs with diffuse PC, but larger series are needed to confirm these data.

No Advantage of Expanded Polytetrafluoroethylene and Fluorinated Ethylene Propylene-Covered Stents over Uncovered Nitinol Stents for Percutaneous Palliation of Malignant Infrahilar Biliary Obstruction: Results of a Single-Center Prospective Randomized Trial.

PURPOSE: To prove that covered stents are more efficacious than uncovered stents regarding patency, safety, enabling of chemotherapy, and survival in percutaneous palliation of malignant infrahilar biliary obstruction. MATERIALS AND METHODS: After failed endoscopic treatment, 154 patients with obstructive jaundice caused by unresectable infrahilar malignancy were randomly allocated to receive an expanded polytetrafluoroethylene and fluorinated ethylene propylene-covered or an uncovered nitinol stent. Occlusion rate, patency, and survival were assessed. Safety and clinical success in terms of chemotherapy were compared. RESULTS: Three patients were excluded post hoc. Fifteen patients died within 7 d and were excluded from patency analysis. Occlusion rates were 32% (21 of 66) for covered and 29% (20 of 70) for uncovered stents (P = .7). Estimated median patency durations were 308 d (95% confidence interval [CI], 178-438 d) for covered and 442 d (95% CI, 172-712 d) for uncovered stents (P = .1). Serious adverse events (P = 1.0) and 30-day mortality (P = .5) were equivalent between groups. At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001). In the covered stent group, 35 patients (48%) received palliative chemotherapy, vs 29 (37%) in the uncovered stent group (P = .2). Estimated median survival times were 96 days (95% CI, 68-124 d) with covered stents and 75 days (95% CI, 42-108 d) with uncovered stents (P = .6). CONCLUSIONS: In malignant infrahilar biliary obstruction not amenable to endoscopy, no improvement in patency or survival with percutaneously placed covered stents could be confirmed. Covered and uncovered stent types exhibit similar safety profiles and clinical success rates.

Retrieval anchor-assisted endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction.

OBJECTIVES: Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is an emerging procedure for gastric outlet obstruction (GOO) as an alternative to endoscopic stent placement in the duodenum or surgery; however, it is technically challenging. This study aimed to evaluate the safety, success rate, and adverse events rate associated with retrieval anchor-assisted EUS-GE. METHODS: Data from patients who underwent retrieval anchor-assisted EUS-GE for malignant and benign GOO were retrospectively analyzed. Patients' clinical and demographic characteristics, procedure time, and success and adverse event rates were recorded. RESULTS: A total of 10 patients (6 females; mean age 63.2 ± 5.8 years) were included in our study. Nine cases were malignant and one case was benign GOO. Nine patients received retrievable anchor-assisted EUS-GE for GOO. One patient received retrievable anchor-assisted EUS-GE and concurrent EUS-guided hepatogastrostomy due to the biliary obstruction. There were no complications during any of the procedures. The rate of technical and clinical success was 100%. CONCLUSIONS: EUS-GE is a safe and effective procedure for GOO. The retrieval anchor can make EUS-GE easier to perform successfully.

Stent placement with iodine-125 seeds strand effectively extends the duration of stent patency and survival in patients with unresectable malignant obstructive jaundice.

Background: This study aimed to compare the treatment outcomes and safety between stent placement with or without Iodine-125 (125I) seeds strand for patients with unresectable malignant obstructive jaundice (MOJ).Methods: A total of 84 patients with unresectable MOJ treated in our hospital were retrospectively included and divided into the stent group (n = 54) undergoing biliary stent placement and the stent + seeds group (n = 30) receiving stent placement with 125I seeds strand. The therapeutic outcome, postoperative complications, duration of patient survival and stent patency were compared between groups. Kaplan-Meier survival analysis was performed to compare the duration of patient survival and stent patency between groups. Cox-regression analysis was performed to investigate predictive factors for disease-free survival and overall survival.Results: The stent + seeds group had significantly longer duration of patency (231.57 ± 256.54 vs. 110.37 ± 120.52) and overall survival (310.57 ± 330.54 vs. 173.15 ± 219.40) than the stent group (both p < .05). In addition, Kaplan-Meier survival analysis confirmed that the stent + seeds group had longer duration of patency (log-rank test, p = .001) and higher overall survival rate (log-rank test, p = .020) than the stent group. Furthermore, Cox-regression analysis demonstrated that treatment methods was an independent factor associated with disease-free survival (HR: 0.36, 95% CI: 0.19-0.70; p = .003) and overall survival (HR: 1.01, 95% CI: 1.00-1.01; p < .001).Conclusion: The stent placement with 125I seeds strand can significantly improve the primary patency rate and overall survival time in MOJ patients.

A Prospective, Multi-Center Phase I Study of Postoperative Enoxaparin Treatment in Patients Undergoing Curative Hepatobiliary-Pancreatic Surgery for Malignancies.

BACKGROUND: Venous thromboembolism (VTE) is one of the critical complications that can occur after surgery. A positive association between cancer and VTE risk is well established; however, the safety and efficacy of VTE prophylaxis have not been established in hepatobiliary-pancreatic surgery, especially in surgery for malignancies. METHODS: A prospective, multi-center Phase I study to determine the safety of enoxaparin was performed. Subcutaneous injection of enoxaparin was initiated 48-72 h after surgery and repeated for 8 days. The primary endpoint was the incidence of bleeding events. This study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000007761). RESULTS: A total of 154 patients was registered and 133 patients including 74 hepatectomies and 35 pancreaticoduodenectomies were analyzed. Three patients (2.3%) exhibited major bleeding events postoperatively, while 7 (5.2%) had minor bleeding. No Symptomatic VTE was observed. CONCLUSIONS: Our study indicated that enoxaparin was well tolerated and safe for patients who received hepatobiliary-pancreatic surgery for malignancies.

Endoscopic ultrasound-guided versus endoscopic retrograde cholangiopancreatography-guided biliary drainage for primary treatment of distal malignant biliary obstruction: A systematic review and meta-analysis.

OBJECTIVES: Current evidence supporting the utility of endoscopic ultrasound-guided biliary drainage (EUS-BD) as primary treatment for distal malignant biliary obstruction (MBO) is limited. We conducted a meta-analysis to compare the performance of EUS-BD and endoscopic retrograde cholangiopancreatography-guided biliary drainage (ERCP-BD) as primary palliation of distal MBO. METHODS: We searched several databases for comparative studies evaluating EUS-BD vs. ERCP-BD in primary drainage of distal MBO up to 28 February 2019. Primary outcomes were technical success and clinical success. Secondary outcomes included adverse events, stent patency, stent dysfunction, tumor in/overgrowth, reinterventions, procedure duration, and overall survival. RESULTS: Four studies involving 302 patients were qualified for the final analysis. There was no difference in technical success (risk ratio [RR] 1.00; 95% confidence interval [95% CI] 0.93-1.08), clinical success (RR 1.00; 95% CI 0.94-1.06) and total adverse events (RR 0.68; 95% CI: 0.31-1.48) between the two procedures. EUS-BD was associated with lower rates of post-procedure pancreatitis (RR 0.12; 95% CI 0.02-0.62), stent dysfunction (RR 0.54; 95% CI 0.32-0.91), and tumor in/overgrowth (RR 0.22; 95% CI 0.07-0.76). No differences were noted in reinterventions (RR 0.59; 95% CI 0.21-1.69), procedure duration (weighted mean difference -2.11; 95% CI -9.51 to 5.29), stent patency (hazard ratio [HR] 0.61; 95% CI 0.34-1.11), and overall survival (HR 1.00; 95% CI 0.66-1.51). CONCLUSIONS: With adequate endoscopy expertise, EUS-BD could show similar efficacy and safety when compared with ERCP-BD for primary palliation of distal MBO and exhibits several clinical advantages.

Usefulness of scoring systems in outcome prediction for older cancer patients undergoing abdominal surgery.

BACKGROUND: Several postoperative outcome scoring systems have been developed and validated, combining both pre- and intraoperative factors. Among others are the Portsmouth Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity (P-POSSUM), the Estimation of Physiologic Ability and Stress (E-PASS) and the Surgical Apgar Score combined with the American Society of Anesthesiologists physical status classification (SASA). The aim of this study was to compare the above scoring systems in the prediction of 30-day postoperative outcome in older patients with cancer undergoing abdominal surgery. METHODS: Consecutive patients ≥70 years were prospectively enrolled. Pre- and intraoperative variables were used to calculate the scores, the ROC and perform logistic regression analysis. RESULTS: The study sample comprised 201 patients with a median age of 77 (range 70-93) years. The most common surgical procedure was for colorectal (75%), followed by gastric (10.4%) pancreas (7.0%), gall bladder (3.5%), small bowel (2.5%), and other (1.5%) types of cancer. All scores were independent predictors of 30-day postoperative mortality. In case of 30-day morbidity only SASA turned to be significant. The ROC curves were highly valid and area under the curve showed fair to good discriminatory ability (0.60-0.77) for 30-day postoperative mortality and fair (AUC 0.6) in case of SASA for the 30-day postoperative. CONCLUSION: The SASA, E-PASS, and P-POSSUM were confirmed to be predictive of 30-day postoperative mortality in older patients undergoing abdominal elective cancer surgery. Only SASA demonstrated as independent factor predicting postoperative 30-day major morbidity.

[Mechanisms and prevention of biliary stent occlusion]. / Mekhanizmy okklyuzii biliarnykh stentov i vozmozhnye sposoby ee profilaktiki.

One of significant achievements of modern endoscopy is development of retrograde biliary stenting for obstructive jaundice. This method ensured widespread application of endoscopic decompression in the treatment of patients with malignant biliary obstruction as preparation before radical surgery and final palliative care. Endoscopic retrograde transpapillary stenting firmly took its place together with antegrade and percutaneous stenting. There are certain advantages of this technique including minimally invasiveness and favorable quality of life. However, this approach is associated with some drawbacks associated with stent occlusion and difficult correction of this complication. The maximum diameter of the plastic stent (PS) is determined by the width of the working channel of the duodenoscope. In this regard, self-expandable metal stents (SEMS) were developed to increase the diameter of bile drainage channel. SEMS are associated with prolonged function. However, there is another problem. It is a germination of SEMS followed by impossible removal of the stent for its subsequent replacement. A further step in development of endoscopic biliary stents was the use of special SEMS coating to exclude tumor or granulation ingrowth. The problem of biliary stent occlusion remains relevant despite some improvement of stenting results. Mechanisms of occlusion of biliary stents and prevention of these events are discussed in this review.

Risk Prediction for Early Biliary Infection after Percutaneous Transhepatic Biliary Stent Placement in Malignant Biliary Obstruction.

PURPOSE: To establish a nomogram for predicting the occurrence of early biliary infection (EBI) after percutaneous transhepatic biliary stent (PTBS) placement in malignant biliary obstruction (MBO). MATERIALS AND METHODS: In this multicenter study, patients treated with PTBS for MBO were allocated to a training cohort or a validation cohort. The independent risk factors for EBI selected by multivariate analyses in the training cohort were used to develop a predictive nomogram. An artificial neural network was applied to assess the importance of these factors in predicting EBI. The predictive accuracy of this nomogram was determined by concordance index (c-index) and a calibration plot, both internally and externally. RESULTS: A total of 243 patients (training cohort: n = 182; validation cohort: n = 61) were included in this study. The independent risk factors were length of obstruction (odds ratio [OR], 1.061; 95% confidence interval [CI], 1.013-1.111; P = .012), diabetes (OR, 5.070; 95% CI, 1.917-13.412; P = .001), location of obstruction (OR, 2.283; 95% CI, 1.012-5.149; P = .047), and previous surgical or endoscopic intervention (OR, 3.968; 95% CI, 1.709-9.217; P = .001), which were selected into the nomogram. The c-index values showed good predictive performance in the training and validation cohorts (0.792 and 0.802, respectively). The optimum cutoff value of risk was 0.25. CONCLUSIONS: The nomogram can facilitate the early and accurate prediction of EBI in patients with MBO who underwent PTBS. Patients with high risk (> 0.25) should be administered more effective prophylactic antibiotics and undergo closer monitoring.

Association of plasma retinol levels with incident cancer risk in Chinese hypertensive adults: a nested case-control study.

We aimed to investigate the association between plasma retinol and incident cancer among Chinese hypertensive adults. We conducted a nested case-control study, including 231 patients with incident cancer and 231 matched controls during a median 4·5-year follow-up of the China Stroke Primary Prevention Trial. There was a significant, inverse association between retinol levels and digestive system cancer (per 10 µg/dl increases: OR 0·79; 95 % CI 0·69, 0·91). When compared with participants in the first quartile of retinol (< 52·3 µg/dl), a significantly lower cancer risk was found in participants in quartile 2-4 ( ≥ 52·3 µg/dl: OR 0·31; 95 % CI 0·13, 0·71). However, there was a U-shaped association between retinol levels and non-digestive system cancers where the risk of cancers decreased (although not significantly) with each increment of plasma retinol (per 10 µg/dl increases: OR 0·89; 95 % CI 0·60, 1·31) in participants with retinol < 68·2 µg/dl, and then increased significantly with retinol (per 10 µg/dl increase: OR 1·65; 95 % CI 1·12, 2·44) in participants with retinol ≥ 68·2 µg/dl. In conclusion, there was a significant inverse dose-response association between plasma retinol and the risk of digestive system cancers. However, a U-shaped association was observed between plasma retinol and the risk of non-digestive cancers (with a turning point approximately 68·2 µg/dl).

The safety of newly developed automatic temperature-controlled endobiliary radiofrequency ablation system for malignant biliary strictures: A prospective multicenter study.

BACKGROUND AND AIMS: Catheter-based endobiliary radiofrequency ablation (RFA) is an endoscopic local treatment for patients with malignant biliary stricture (MBS). However, excessive heating of the bile duct by the current RFA system can induce serious complications. Recently, a new RFA system with automatic temperature control was developed. In the present study, we examined the safety of the new RFA system in patients undergoing endobiliary RFA for extrahepatic MBS. METHODS: This prospective, multicenter study enrolled patients with unresectable or inoperable extrahepatic (> 2 cm from the hilum) MBS. Endobiliary RFA was performed using a newly developed RFA catheter (ELRA™, STARmed, Goyang, Korea) at a setting of 7 or 10 W for 120 s and with a target temperature of 80°C. A self-expandable metallic stent was inserted after endobiliary RFA. The rate of procedure-related adverse events was assessed. RESULTS: The 30 patients were enrolled in this study. Cholangiocarcinoma was diagnosed in 19 patients, pancreatic cancer was found in 9, and gallbladder cancers were recorded in 2. The mean stricture length was 22.1 ± 6.6 mm. Post-procedural adverse events occurred in three patients (10.0%; 2 mild pancreatitis and 1 cholangitis) without hemobilia and bile duct perforation. The pancreatitis and cholangitis resolved with conservative treatment. The cumulative duration of stent patency and survival were 236 and 383 days, respectively. CONCLUSIONS: Automatic temperature-controlled endobiliary RFA using a newly developed catheter was safely applied in patents with extrahepatic MBS. Further prospective studies are needed to confirm the efficacy of endobiliary RFA for MBS.

Usefulness of newly modified fully covered metallic stent of 12 mm in diameter and anti-migration feature for periampullary malignant biliary strictures: Comparison with conventional standard metal stent.

BACKGROUNDS: Fully covered self-expandable metal stent (FCSEMS) are preferred for distal malignant biliary stricture (MBS). However, stent migration is a major adverse event of FCSEMS, especially for far distal MBS. We evaluated the usefulness of newly modified FCSEMS (M-FCSEMS) having 12 mm in diameter and anti-migration feature to minimize stent migration compared with the conventional FCSEMS (C-FCSEMS). METHODS: Total 102 patients were enrolled between January 2015 and September 2017 in this prospective comparative study; 50 were allocated to the M-FCSEMS group and 52 to the C-FCSEMS group. The primary outcome was stent migration, and the secondary outcomes were other adverse events, stent occlusion rate, and stent patency during the follow-up period. RESULTS: The baseline characteristics of the two groups did not significantly differ. Endoscopic stent placement was technically successful in all patients. Stent migration occurred in 8.0% (4/50) of the patients in the M-FCSEMS group and 23.1% (12/52) of those in the C-FCSEMS group (P = 0.036). The other adverse events, including stent-related pancreatitis and cholecystitis did not significantly differ between the two groups (P = 0.415). Stent occlusion occurred in 23.9% (11/46) of the patients in the M-FCSEMS group and 37.5% (15/40) in the C-FCSEMS group (P = 0.171). Stent patency was significantly longer in the M-FCSEMS group than in the C-FCSEMS group (228 vs 157 days, P = 0.048). CONCLUSIONS: Modified FCSEMS with 12-mm diameter and anti-migration feature significantly decreased the risk of stent migration and had longer patency compared with C-FCSEMS in patients with periampullary MBS.

Modified non-flared fully covered self-expandable metal stent versus plastic stent for preoperative biliary drainage in patients with resectable malignant biliary obstruction.

BACKGROUND AND AIM: Fully covered self-expandable metal stents (FCSEMS) may be better than plastic stents (PS) for preoperative biliary drainage (PBD) to relieve cholangitis or jaundice for resectable malignant biliary obstruction (MBO). However, modification of current FCSEMS designed originally for nonresectable MBO is needed to be a proper stent for PBD. The aim of this study was to evaluate the possible superiority of non-flared modified FCSEMS (M-FCSEMS) with 12-mm diameter and waist of central portion over PS in patients with resectable MBO. METHODS: Eighty-five consecutive patients underwent PBD followed by operation from August 2015 to December 2017. In each M-FCSEMS and PS group, 29 patients were matched for age, sex, body mass index, and preoperative albumin and bilirubin levels. RESULTS: The overall technical success rates of PBD using M-FCSEMS and PS were 100%. The time to operation was similar between groups (18.6 ± 10.8 vs 19.3 ± 11.6 days, respectively; P = 0.843). The prevalence of PBD-related adverse events (AEs) was 6.9% (2/29) in the M-FCSEMS group versus 27.6% (8/29) in the PS group (P = 0.037). Re-intervention before operation was required in 20.7% (6/29) of patients in the PS group but no patients in the M-FCSEMS group (P = 0.023). No differences were found between perioperative AEs in the M-FCSEMS and PS groups (27.5% vs 31.0%, respectively; P = 0.773). CONCLUSION: Modified FCSEMS led to lower PBD-related AEs, re-intervention rate, and comparable perioperative AEs compared with PS. M-FCSEMS may be a potential novel stent for PBD in patients with resectable MBO.

Palliative surgical bypass is superior to palliative endoscopic stenting in patients with malignant gastric outlet obstruction: systematic review and meta-analysis.

BACKGROUND: Gastrojejunostomy (GJ) and self-expanding metal stents (SEMS) are the two most common palliative treatment options for patients with malignant gastric outlet obstruction (GOO). Randomised trials and retrospective studies have shown discrepant results, so that there is still a controversy regarding the optimal treatment of GOO. METHODS: Medline, Web of Science and Cochrane Library were systematically searched for studies comparing GJ to SEMS in patients with malignant GOO. Primary outcomes were survival and postoperative mortality. Secondary outcomes were frequency of re-interventions, major complications, time to oral intake and length of hospital stay. RESULTS: Twenty-seven studies, with a total of 2.354 patients, 1.306 (55.5%) patients in the SEMS and 1.048 (44.5%) patients in the GJ group, were considered suitable for inclusion. GJ was associated with significantly longer survival than SEMS (mean difference 43 days, CI 12.00, 73.70, p = 0.006). Postoperative mortality (OR 0.55, CI 0.27, 1.16, p = 0.12) and major complications (OR 0.73, CI 0.5, 1.06, p = 0.10) were similar in both groups. The frequency of re-interventions, however, was almost three times higher in the SEMS group (OR 2.95, CI: 1.70, 5.14, p < 0.001), whereas the mean time to oral intake and length of hospital stay were shorter in the SEMS group (mean differences - 5 days, CI - 6.75, - 3.05 days, p < 0.001 and - 10 days, CI - 11.6, - 7.9 days, p < 0.001, respectively). CONCLUSIONS: Patients with malignant GOO and acceptable performance status should be primarily considered for a palliative GJ rather than SEMS.

EUS-guided gastroenterostomy versus enteral stent placement for palliation of malignant gastric outlet obstruction.

BACKGROUND: EUS-guided gastroenterostomy (EUS-GE) is a novel procedure for palliation of malignant gastric outlet obstruction (GOO); however, data comparing EUS-GE to enteral stent placement are limited. We aimed to compare clinical outcomes between EUS-GE and enteral stent placement in the palliation of malignant GOO. METHODS: Retrospective analysis of a prospectively collected database on patients who underwent EUS-GE or enteral stent placement for palliation of malignant GOO from 2014 to 2017 was conducted. Primary outcome was the rate of stent failure requiring repeat intervention. Secondary outcomes included technical and clinical success, time to repeat intervention, length of hospital stay, and adverse events. RESULTS: A total of 100 consecutive patients (mean age 65.9 ± 11.9 years, 44.0% female) were identified, of which 78 underwent enteral stent placement, and 22 underwent EUS-GE. Rate of stent failure requiring repeat intervention was higher in the enteral stent group than the EUS-GE group (32.0% vs. 8.3%, p = 0.021). Technical success was achieved in 100% in both groups. Higher initial clinical success was attained in the EUS-GE group than the enteral stent group (95.8% vs. 76.3%, p = 0.042). Mean length of hospital stay following stent placement was similar between groups (p = 0.821). The enteral stent group trended towards increased adverse events (40.2% vs. 20.8%, p = 0.098). Kaplan-Meier analysis showed decreased stent function in the enteral stent group (p = 0.013). CONCLUSION: Compared to enteral stent placement, EUS-GE has a higher rate of initial clinical success and lower rate of stent failure requiring repeat intervention. EUS-GE may be offered for selected patients with malignant GOO in centers with extensive experience.