Efficacy of hemostasis by gastroduodenal covered metal stent placement for hemorrhagic duodenal stenosis due to pancreatobiliary cancer invasion: a retrospective study.

BACKGROUND/AIMS: Advanced pancreatic and biliary tract cancers can invade the duodenum and cause duodenal hemorrhagic stenosis. This study aimed to evaluate the efficacy of covered self-expandable metal stents in the treatment of cancer-related duodenal hemorrhage with stenosis. METHODS: Between January 2014 and December 2016, metal stents were placed in 51 patients with duodenal stenosis. Among these patients, a self-expandable covered metal stent was endoscopically placed in 10 patients with hemorrhagic duodenal stenosis caused by pancreatobiliary cancer progression. We retrospectively analyzed the therapeutic efficacy of the stents by evaluating the technical and clinical success rates based on successful stent placement, degree of oral intake, hemostasis, stent patency, and overall survival. RESULTS: The technical and clinical success rates were 100%. All 10 patients achieved a gastric outlet obstruction scoring system score of three within two weeks after the procedure and had no recurrence of melena. The median stent patency duration and overall survival after stent placement were 52 days (range, 20-220 days) and 66.5 days (range, 31-220 days), respectively. CONCLUSIONS: Endoscopic placement of a covered metal stent for hemorrhagic duodenal stenosis associated with pancreatic or biliary tract cancer resulted in duodenal hemostasis, recanalization, and improved quality of life.

Safety of propofol sedation administered by interventional radiologists for radiofrequency ablation in patients with hepatocellular carcinoma.

PURPOSE: To evaluate the safety of propofol sedation administered by interventional radiologists during radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Propofol sedation was administered by interventional radiologists in 72 patients (85 procedures, 93 tumors) during RFA for HCC between August 2018 and December 2020. Interventional radiologists equipped with adequate knowledge and skills in sedation and respiratory management were responsible for sedation. Sedation was carefully assessed based on vital signs, including end-tidal carbon dioxide, consciousness status, and bispectral index. The primary endpoint was the incidence of sedation-related complications, which were evaluated separately as respiratory and cardiovascular complications. Secondary endpoints were technical success rate, ablation-related complications, and local tumor control rate. Technical success was defined as completion of ablation in the planned area. Complications were evaluated using the Clavien-Dindo classification. Sedation-related complications, technical success rate, and ablation-related complications were evaluated on a procedure basis, and local tumor control was evaluated on a tumor basis. RESULTS: Respiratory and cardiovascular complications were observed in eight (8/85, 9.4%) and two (2/85, 2.4%) patients, respectively. Four patients required the jaw thrust maneuver due to glossoptosis, whereas a decrease in oxygen saturation to < 90% was recorded in the other four patients. However, these were temporary, and none required manual ventilation or endotracheal intubation. Bradycardia (< 50 bpm) was detected in two patients; one recovered immediately without treatment, whereas the other rapidly improved after atropine sulfate administration. No severe hypotension (< 80 mmHg) was observed. The technical success rate was 100% (85/85). Grade 3 ablation-related complications were identified in three patients (3/85, 3.5%). The local tumor control rate was 95.7% (89/93). CONCLUSION: Propofol sedation can be safely administered by interventional radiologists during RFA for HCC. Although it requires special safety considerations, it may be a sedation option during hepatic RFA.

Feasibility and safety of direct percutaneous embolization of lymphopseudoaneurysm for postoperative lymphatic leakage.

The treatment strategy for refractory postoperative lymphatic leakage is controversial. While the utility of direct percutaneous embolization of lymphopseudoaneurysm has been investigated, only a few reports on this topic exist. The aim of this study was to evaluate the technical and clinical feasibility and safety of direct percutaneous embolization of lymphopseudoaneurysm for refractory postoperative lymphatic leakage. This case series included six consecutive patients who underwent direct percutaneous embolization of lymphopseudoaneurysm for refractory postoperative lymphatic leakage. Technical success (successful percutaneous approach and injection of NBCA glue to the lymphopseudoaneurysm), clinical success (unnecessity of percutaneous drainage tube of the lymphatic leakage), treatment duration (the duration from the treatment to the achievement of clinical success) and procedure-related complications were mainly evaluated. Direct percutaneous embolization of the lymphopseudoaneurysm using NBCA glue was successfully performed in all cases. Clinical success was achieved in five of the six cases (83%). The mean treatment period was 9 days for the cases with clinical success. No major complications occurred postoperatively. In conclusion, direct percutaneous embolization of lymphopseudoaneurysm may become a feasible and safe treatment option for cases of refractory postoperative lymphatic leakage.

Technical Feasibility and Safety of Central Venous Ports for Intravenous Chemotherapy in Infants With Retinoblastoma: A Retrospective Study.

PURPOSE: The central venous port (CVP) is widely used for intravenous chemotherapy (IVC) in adult patients because of its lower infection rates and easier management than that of a central venous catheter. However, the feasibility and safety of the CVP for IVC in infants remain unknown. This study evaluated the usefulness of CVP for IVC in infants with retinoblastoma. METHODS: The usefulness of CVP was retrospectively evaluated using technical success rates, the safety of CVP placement, and postoperative procedure-related complications in 18 infants with retinoblastoma. This study was conducted at the National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan. RESULTS: The technical success rate was 100% (18/18) without any procedure-related complications. The sum duration of CVP implantation was 12,836 days (mean: 713 ± 453 days, range: 10-1,639 days). Postoperative complications were observed in two cases; one was a port reversal after 20 days, which was reversed by incisional surgery, and another was a catheter-related bloodstream infection after eight days, resulting in CVP removal. The total incidence of CVP-related infections was 5.6% (1/18) and 0.08/1000 catheter days. No other CVP-related complications were noted. CONCLUSION: The use of the CVP for IVC in infants with retinoblastoma was feasible with few complications.

A Phase 2, Prospective, Multicenter, Single-Arm Trial of Transarterial Chemoembolization Therapy in Combination Strategy with Lenvatinib in Patients with Unresectable Intermediate-Stage Hepatocellular Carcinoma: TACTICS-L Trial.

Introduction: Transarterial chemoembolization (TACE) is the standard treatment for unresectable intermediate-stage hepatocellular carcinoma (HCC), but recurrence after TACE is common. The present phase 2, prospective, multicenter, single-arm trial, the TACTICS-L trial, investigated the efficacy and safety of TACE plus lenvatinib (LEN), a drug that more strongly promotes vascular normalization and has a better objective response rate (ORR) than sorafenib (jRCTs031180074). Methods: Participants were patients with HCC who had not previously received systemic therapy, hepatic arterial infusion chemotherapy, or immunotherapy and who were ineligible for resection or percutaneous ablation therapy. LEN was to be administered 14-21 days before the first TACE, stopped 2 days before TACE, and resumed 3 days after TACE. Key inclusion criteria were unresectable HCC, Child-Pugh A liver function, 0-2 prior TACE sessions, tumor size ≤10 cm, number of tumors ≤10, and ECOG performance status 0-1. Key exclusion criteria were vascular invasion and extrahepatic spread. The primary endpoint was progression-free survival (PFS) by RECICL, and secondary endpoints were time to untreatable progression, ORR, overall survival (OS), and safety. Results: A total of 62 HCC patients were enrolled in this trial. The median age was 72 years, 77.4% of patients were men, and 95.2% had PS 0. The primary endpoint of median PFS was 28.0 months (90% confidence interval [CI] 25.1-31.0) after a minimum 24 months of follow-up. The secondary endpoint of median OS was not reached (90% CI 35.5 months-NR). LEN-TACE achieved a high response rate and high complete response (CR) rate (4 weeks after the first TACE: ORR 79.0%, CR rate 53.2%; best response: ORR 88.7%, CR rate 67.7%) by RECICL. Exploratory subgroup analyses showed that the characteristics of responders/nonresponders (ORR and CR rate) were similar and that LEN-TACE would be effective in all subgroups, including the population in whom TACE alone would be less likely to be curative (e.g., patients with the non-simple nodular type or a high tumor burden). The relative dose intensity of LEN before the first TACE was important for achieving higher CR rate/ORR by LEN-TACE. No new safety concerns were observed. Conclusion: The results of this trial provide encouraging evidence, supporting the efficacy and favorable safety profile of LEN-TACE in patients who are ineligible for locoregional therapy.

Artificial Pneumothorax Using the Liver-Directed Approach and Seldinger's Technique: Technical Feasibility and Safety.

Purpose This study aimed to evaluate the technical feasibility and safety of artificial pneumothorax induction for percutaneous procedures using the liver-directed approach and Seldinger's technique. Materials and methods The data of 25 consecutive patients who underwent percutaneous procedures after inducing artificial pneumothorax were reviewed retrospectively. The liver surface was punctured with an 18-gauge indwelling needle via the intercostal space in the inferior thoracic cavity under ultrasound guidance, avoiding the lung parenchyma and leaving the catheter in place. After a deep inhalation pulled the catheter tip into the pleural cavity, a hydrophilic guidewire was inserted through the catheter. Finally, a small-diameter catheter was inserted into the pleural cavity over the guidewire to induce artificial pneumothorax. Procedure time (the time from local anesthesia to completion of the procedure), technical success (successful induction of artificial pneumothorax), clinical success (successful completion of the percutaneous procedure), and complications (categorized according to the Clavien-Dindo classification) were evaluated in this study. Results The artificial pneumothorax induction was successful in all cases. Clinical success was achieved in 23 of 25 procedures (92%). No severe complications were observed. Conclusion The liver-directed approach and Seldinger's technique for inducing artificial pneumothorax was safe and feasible for avoiding lung injury.

Guidelines for Central Venous Port Placement and Management (Abridged Translation of the Japanese Version).

The central venous port has been widely used for patients who require long-term intravenous treatments, and the number of palcement has been increasing. The Japanese Society of Interventional Radiology developed a guideline for central venous port placement and management to provide evidence-based recommendations to support healthcare providers in the decision-making process regarding the central venous port. The guideline consisted of two parts: (i) a comprehensive review of topics including preoperative preparation, techniques for placement or removal, complications, and maintenance methods and (ii) recommendations for the six clinical questions regarding blood vessels for central venous port placement, port implantation site, prophylactic antibiotic therapy, imaging guidance for puncture, disinfectant prior to accessing the central venous port, and the optimal procedure at the end of drug administration via the central venous port, generated on the basis of the rating quality of evidence by systematic review.

Necessity of Prophylactic Anticoagulation Therapy Following Inferior Vena Cava Stent Placement in Patients with Cancer.

Purpose: Although percutaneous stent placement for malignant inferior vena cava syndrome is a highly feasible and effective treatment option, there is no clear evidence for the necessity of prophylactic anticoagulation therapy after inferior vena cava stent placement. This study retrospectively evaluated the necessity of prophylactic anticoagulation following inferior vena cava stent placement in patients with malignant inferior vena cava syndrome. Methods: The data of 54 patients (28 men and 26 women; median age 61.2 years) with malignant inferior vena cava syndrome who received inferior vena cava stent placement between 2011 and 2021 were retrospectively reviewed. Prophylactic anticoagulation was administered to 15 of 54 patients (27.8%) following stent placement. Symptom recurrence rates at 1 and 2 months after stent placement were compared between patients with and without prophylactic anticoagulation using Gray relational analysis. The timeline of symptom recurrence, survival time, and adverse events were also evaluated. Results: At 1 and 2 months, symptom recurrence rates were 48.6% and 71.4%, respectively, in patients with prophylactic anticoagulation and 28.3% and 37.0%, respectively, in patients without prophylactic anticoagulation. The overall median follow-up duration was 27 days and that of the patients with and without prophylactic anticoagulation was 37 and 25 days, respectively. The median survival times of patients with and without anticoagulation therapy were 69 and 30 days, respectively (p = 0.236). No procedure-related complications occurred. Conclusions: There was no significant difference in the symptom recurrence rates after inferior vena cava stent placement with or without prophylactic anticoagulation in this study.

Mitigation of paclitaxel-induced peripheral neuropathy in breast cancer patients using limb-cooling apparatus: a study protocol for a randomized controlled trial.

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse events that can significantly impair the quality of life of patients. Although limb cooling may be beneficial for preventing CIPN, logistical challenges exist in ensuring consistent efficacy and safety. The purpose of this randomized controlled trial is to validate whether limb cooling with strict temperature control can reduce CIPN in patients with breast cancer receiving weekly paclitaxel as a perioperative treatment. Methods: This study is a multicenter, double-blinded, randomized controlled trial. We plan to enroll patients with breast cancer who are scheduled to receive 12 weekly doses of paclitaxel (60 min 80 mg/m2 intravenous infusion) as perioperative chemotherapy. Patients will be randomly divided into the intervention or control groups and undergo limb cooling therapy maintained at a constant temperature of 13°C and 25°C, respectively. The primary endpoint is the proportion of patients who report Patient Neurotoxicity Questionnaire (PNQ) ≥ D in their limbs by the end of the study treatment or at the time of discontinuation. Discussion: The results of this trial will contribute to the establishment of new evidence for limb cooling therapy in the mitigation of CIPN and present a safe and stable cooling device that may be suitable for use in the clinic. Clinical trial registration: https://jrct.niph.go.jp/en-latest-detail/jRCT2032210115, identifier jRCT2032210115.

Percutaneous Image-Guided Transesophageal Long Intestinal Tube Placement for Palliative Decompression in Advanced Cancer Patients with Unresectable Malignant Small Bowel Obstruction.

PURPOSE: To assess the safety and efficacy of long intestinal tube placement following percutaneous image-guided esophagostomy for palliative decompression of incurable malignant small bowel obstruction. MATERIALS AND METHODS: Between January 2013 and June 2022, a single-institution retrospective study was conducted to examine patients undergoing percutaneous transesophageal intestinal intubation for an occluded intestinal segment. Patients' baseline characteristics, procedural details, and clinical courses were reviewed. Severe complications were defined as those with ≥ 4 grade according to the CIRSE classification. RESULTS: This study included 73 patients (mean age, 57.7 years) who underwent 75 procedures. All bowel obstructions were caused by peritoneal carcinomatosis or similar disease, which precluded transgastric access in almost 50% of the patients due to massive cancerous ascites (n = 28), diffuse gastric involvement (n = 5), or omental dissemination in front of the stomach (n = 3). Technical success (appropriate tube positioning) was achieved in 98.7% (74/75) of procedures. The cumulative 1-month overall survival and sustained clinical success (adequate bowel decompression) rates were estimated at 86.8% and 88%, respectively, using Kaplan-Meier analysis. At the median survival of 70 days, the disease progression required other gastrointestinal interventions, including additional tube insertion, repositioning, or venting enterostomy in 16 patients (21.9%). The severe complication rate was 4% (3/75); one patient aspirated to death due to tube clogging and two encountered fatal perforation of isolated intestinal loops developing far beyond the tip of the indwelling tube. CONCLUSION: Percutaneous image-guided transesophageal intestinal intubation achieves feasible bowel decompression as palliative care in advanced cancer patients. LEVEL OF EVIDENCE: Level 4, Case Series.

Clinical outcomes of image-guided percutaneous drainage of pericardial effusion in cancer patients: A single-center retrospective analysis.

AIM: Catheter removal, survival, and recurrence rates after percutaneous pericardial effusion drainage in cancer patients are not fully understood. We evaluated the clinical outcomes of image-guided percutaneous pericardial effusion drainage in cancer patients. METHODS: From January 2014 to September 2017, 113 percutaneous drainages for symptomatic pericardial effusion were performed in 100 cancer patients (median 60 years; range, 7-84 years) using ultrasound or angio-computed tomography. An 8-Fr drainage catheter was placed using the Seldinger technique via the subxiphoid (n = 73), apical (n = 23), or left parasternal (n = 17) routes. Success rates, complications, and postprocedural clinical outcomes of drainages were retrospectively assessed. RESULTS: The technical and clinical success rates were 100% and 99%, respectively, without major complications. The median duration of catheterization and evacuated pericardial effusion volume were 6 days (range, 1-72 days) and 970 ml (range, 140-7635 ml), respectively. Catheters were removed after the first drainage in 86 cases (86%). Symptomatic pericardial effusion recurred in nine patients after catheter removal, in whom redrainages were performed 13 times with a median duration to redrainage time of 48 days (range, 13-529 days). During the follow-up period (median 106 days [range, 1-1396 days]), 61 patients died. The median survival was 140 days (95% confidence interval [CI], 95-276 days), and the median catheter-free survival was 111 days (95% CI, 60-152 days). CONCLUSIONS: Image-guided percutaneous pericardial effusion drainage for cancer patients is safe and helps alleviate symptoms. Additionally, catheter removal is possible in most patients, allowing a catheter-free period for patients.

Conventional or Drug-Eluting Beads? Randomized Controlled Study of Chemoembolization for Hepatocellular Carcinoma: JIVROSG-1302.

Introduction: With the advent of effective systemic therapy, transarterial chemoembolization (TACE) is established as a highly effective locoregional treatment modality for carefully selected patients with hepatocellular carcinoma (HCC). This randomized controlled trial was conducted to clarify whether selective TACE with drug-eluting beads (DEB-TACE) loaded with epirubicin or selective conventional TACE (cTACE) with epirubicin-ethiodized oil might be more effective for obtaining complete response(CR) in patients with HCC. Methods: Between March 2016 and May 2019, Child-Pugh class A or B patients with unresectable HCC who were scheduled to receive selective TACE were randomly assigned at a 1:1 ratio to the DEB-TACE arm or the cTACE arm. The primary endpoint was the CR rate at 3 months, as evaluated according to the modified Response Evaluation Criteria in Solid Tumors by an independent review committee, and the secondary endpoints were the CR rate at 1 month and incidences of adverse events. Results: A total of 200 patients (DEB-TACE, 99 patients; cTACE, 101 patients) were enrolled in the study. The CR rates at 3 months and 1 month were significantly higher in the cTACE arm (75.2%, 84.2%) as compared with the DEB-TACE arm (27.6%, 35.7%). However, the frequencies of adverse events of any grade, including pyrexia (DEB-TACE vs. cTACE, 19.4% vs. 45.5%, p = 0.0001), fatigue (5.1% vs. 15.8%, p = 0.0194), malaise (11.1% vs. 25.7%, p = 0.0103), appetite loss (12.1% vs. 28.7%, p = 0.0048), abdominal pain (12.1% vs. 23.8%, p = 0.0423), increased serum bilirubin (22.2% vs. 48.5%, p = 0.0002), hypoalbuminemia (43.4% vs. 60.3%, p = 0.0154), increased serum aspartate aminotransferase (35.7% vs. 81.2%, p < 0.0001), and increased serum alanine aminotransferase (35.7% vs. 77.2%, p < 0.0001), were also significantly higher in the cTACE arm than in the DEB-TACE arm. Conclusions: Selective cTACE appeared to have higher CR rates for local tumor control as compared to selective DEB-TACE for HCC. However, the frequency of postembolization syndrome was also significantly higher in the cTACE group than in the DEB-TACE group. Thus, to achieve CR, cTACE may be selected over DEB-TACE in patients who can be expected to tolerate postembolization syndrome.

Clinical Practice Guidelines for Hepatic Arterial Infusion Chemotherapy with a Port System Proposed by the Japanese Society of Interventional Radiology and Japanese Society of Implantable Port Assisted Treatment.

Hepatocellular carcinoma is one of the leading causes of cancer-related death both in Japan and globally. In the advanced stage, hepatic arterial infusion chemotherapy (HAIC) is one of the most commonly used treatment options for liver cancer in Japan, and implantation of a catheter system (called a port system) in the body is a treatment method that has evolved mainly in Japan. The Guideline Committee of the Japanese Society of Interventional Radiology and the Japanese Society of Implantable Port Assisted Treatment jointly published clinical practice guidelines for HAIC with a port system to ensure its appropriate and safe performance in Japanese in 2018. We have written an updated English version of the guidelines with the aim of making this treatment widely known to experts globally. In this article, the evidence, method, indication, treatment regimen, and maintenance of the system are summarized.

Final Results of TACTICS: A Randomized, Prospective Trial Comparing Transarterial Chemoembolization Plus Sorafenib to Transarterial Chemoembolization Alone in Patients with Unresectable Hepatocellular Carcinoma.

Introduction: Several clinical trials comparing the efficacy and safety of transarterial chemoembolization (TACE) plus molecular-targeted agents versus TACE alone revealed no clinical benefits in progression-free survival (PFS) or overall survival (OS). Here, we report the final OS analysis from the TACTICS trial, which previously demonstrated significant improvement in PFS with TACE plus sorafenib in patients with unresectable hepatocellular carcinoma (HCC) (NCT01217034). Methods: Patients with unresectable HCC were randomized to a TACE plus sorafenib group (N = 80) or a TACE alone group (N = 76). Patients in the combination treatment group received sorafenib 400 mg once daily for 2-3 weeks before TACE, followed by 800 mg once daily during on-demand conventional TACE sessions until time to untreatable progression. In this trial, TACE-specific PFS was used. TACE-specific PFS is defined as the time from randomization to progressive disease (PD) or death from any cause, and PD was defined as untreatable progression, caused by the inability of a patient to further receive or benefit from TACE for reasons that include intrahepatic tumor progression (25% increase vs. baseline) according to response evaluation criteria in cancer of the liver, the detection of extrahepatic spread, vascular invasion, or transient deterioration of liver function to Child-Pugh C after TACE. Results: At the cut-off date of July 31, 2020, 131 OS events were observed. The median OS was 36.2 months with TACE plus sorafenib and 30.8 months with TACE alone (hazard ratio [HR] = 0.861; 95% confidence interval [CI], 0.607-1.223; p = 0.40, ΔOS, 5.4 months). The updated PFS was 22.8 months with TACE plus sorafenib and 13.5 months with TACE alone (HR = 0.661; 95% CI, 0.466-0.938; p = 0.02). Post-trial treatments with active procedures/agents were received by 47 (58.8%) patients in the TACE plus sorafenib group and 58 (76.3%) in the TACE alone group (p = 0.01). In post hoc analysis, PFS and OS benefit were shown in HCC patients with tumor burden beyond up-to-7 criteria. Conclusions: In TACTICS trial, TACE plus sorafenib did not show significant OS benefit over TACE alone; however, clinical meaningful OS prolongation and significantly improved PFS was observed. Thus, the TACE plus sorafenib can be considered a choice of treatment in intermediate-stage HCC, especially in patients with high tumor burden. Trial Registration: NCT01217034.

Interventional oncology of liver tumors: how it all started and where are we now.

Liver was the very first organ for which interventional procedures were applied for the local treatment of primary and secondary malignancies. In this paper, the history of Interventional Oncology of liver, from the very beginning to the current situation, is summarized, including both percutaneous and intravascular procedures, and together with the evolution of the techniques for image guidance. The main ongoing developments, such as new techniques, combined interventional treatments and association of local interventions with new drugs are briefly described, too.

A novel endoscopic technique using fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy: the saddle-cross technique (with video).

BACKGROUND: In recent years, the number of patients with hepaticojejunostomy anastomotic strictures has increased. Balloon dilation and placement of multiple plastic stents have proven effective for hepaticojejunostomy anastomotic strictures. However, for refractory strictures, there is often a need for repeated endoscopic procedures within a short period. This study aimed to assess the efficacy and safety of the new saddle-cross technique, which uses two fully covered self-expandable metallic stents. METHODS: This was a retrospective analysis of 20 patients with benign hepaticojejunostomy anastomotic strictures who underwent placement of two fully covered self-expandable metallic stents at the National Cancer Center, Japan, from November 2017 to June 2021. RESULTS: The technical and clinical success rates were 100% (20/20). The median time of the procedure was 61 (range 25-122) min. The scheduled stent removal rate was 70% (14/20). Spontaneous dislodgement of the stent was observed on computed tomography in five patients (25.0%). The non-restenosis rate 12 months after the saddle-cross technique was 88.2% (15/17). Procedure-related early adverse events included mild ascending cholangitis in three patients (15.0%) and sepsis in one patient (5.0%). Procedure-related late adverse events included mild ascending cholangitis in three patients (15.0%) and bile duct hyperplasia in one patient (5.0%). CONCLUSIONS: The saddle-cross technique performed using two fully covered self-expandable metallic stents resulted in promising long-term stricture resolution with a high technical success rate. Based on these findings, the saddle-cross method can be considered an option for the standard procedure for benign hepaticojejunostomy anastomotic strictures.