Development of an international glossary for clinical guidelines collaboration.

OBJECTIVES: Clinical practice guidelines (CPGs) are often created through collaboration among organizations. The use of inconsistent terminology may cause poor communication and delays. This study aimed to develop a glossary of terms related to collaboration in guideline development. STUDY DESIGN AND SETTING: A literature review of collaborative guidelines was performed to develop an initial list of terms related to guideline collaboration. The list of terms was presented to the members of the Guideline International Network Guidelines Collaboration Working Group, who provided presumptive definitions for each term and proposed additional terms to be included. The revised list was subsequently reviewed by an international, multidisciplinary panel of expert stakeholders. Recommendations received during this pre-Delphi review were implemented to augment an initial draft glossary. The glossary was then critically evaluated and refined through two rounds of Delphi surveys and a virtual consensus meeting with all panel members as Delphi participants. RESULTS: Forty-nine experts participated in the pre-Delphi survey, and 44 participated in the two-round Delphi process. Consensus was reached for 37 terms and definitions. CONCLUSION: Uptake and utilization of this guideline collaboration glossary by key organizations and stakeholder groups may facilitate collaboration among guideline-producing organizations by improving communication, minimizing conflicts, and increasing guideline development efficiency.

Clinical consensus statement: Establishing the roles of locoregional and systemic therapies for the treatment of intermediate-stage hepatocellular carcinoma in Canada.

BACKGROUND: Hepatocellular carcinoma (HCC) a leading cause of cancer mortality worldwide and approximately one-third of patients present with intermediate-stage disease. The treatment landscape of intermediate-stage HCC is rapidly evolving due to developments in local, locoregional and systemic therapies. Treatment recommendations focused on this heterogenous disease stage and that take into account the Canadian reality are lacking. To address this gap, a pan-Canadian group of experts in hepatology, transplant, surgery, radiation therapy, nuclear medicine, interventional radiology, and medical oncology came together to develop consensus recommendations on management of intermediate-stage HCC relevant to the Canadian context. METHODS: A modified Delphi framework was used to develop consensus statements with strengths of recommendation and supporting levels of evidence graded using the AHA/ACC classification system. Tentative consensus statements were drafted based on a systematic search and expert input in a series of iterative feedback cycles and were then circulated via online survey to assess the level of agreement. RESULTS & CONCLUSION: The pre-defined ratification threshold of 80 % agreement was reached for all statements in the areas of multidisciplinary treatment (n = 4), intra-arterial therapy (n = 14), biologics (n = 5), radiation therapy (n = 3), surgical resection and transplantation (n = 7), and percutaneous ablative therapy (n = 4). These generally reflected an expansion in treatment options due to developments in previously established or emergent techniques, introduction of new and more active therapies and increased therapeutic flexibility. These developments have allowed for greater treatment tailoring and personalization as well as a paradigm shift toward strategies with curative intent in a wider range of disease settings.

Looking Into the Future: The Current and Future State of IR in Canada.

This review explores the priorities and future opportunities of interventional radiology in Canada.

3D US-Based Evaluation and Optimization of Tumor Coverage for US-Guided Percutaneous Liver Thermal Ablation.

Complete tumor coverage by the thermal ablation zone and with a safety margin (5 or 10 mm) is required to achieve the entire tumor eradication in liver tumor ablation procedures. However, 2D ultrasound (US) imaging has limitations in evaluating the tumor coverage by imaging only one or multiple planes, particularly for cases with multiple inserted applicators or irregular tumor shapes. In this paper, we evaluate the intra-procedural tumor coverage using 3D US imaging and investigate whether it can provide clinically needed information. Using data from 14 cases, we employed surface- and volume-based evaluation metrics to provide information on any uncovered tumor region. For cases with incomplete tumor coverage or uneven ablation margin distribution, we also proposed a novel margin uniformity -based approach to provide quantitative applicator adjustment information for optimization of tumor coverage. Both the surface- and volume-based metrics showed that 5 of 14 cases had incomplete tumor coverage according to the estimated ablation zone. After applying our proposed applicator adjustment approach, the simulated results showed that 92.9% (13 of 14) cases achieved 100% tumor coverage and the remaining case can benefit by increasing the ablation time or power. Our proposed method can evaluate the intra-procedural tumor coverage and intuitively provide applicator adjustment information for the physician. Our 3D US-based method is compatible with the constraints of conventional US-guided ablation procedures and can be easily integrated into the clinical workflow.

Survival predictors of 177Lu-Dotatate peptide receptor radionuclide therapy (PRRT) in patients with progressive well-differentiated neuroendocrine tumors (NETS).

PURPOSE: 177Lu-Dotatate is an emerging treatment modality for patients with unresectable or metastatic well-differentiated NETs. This study examines survival predictors in patients who received 177Lu-Dotatate. METHODS: A retrospective single-center review was conducted, examining 47 individuals with progressive well-differentiated NETs treated with 177Lu-Dotatate (four induction cycles of 5.5 GBq at 10-week intervals followed by eight maintenance cycles of 3.7 GBq at 6-month intervals). RESULTS: Median follow-up was 63.1 months with a median progression-free survival (PFS) of 34.1 months. However, median overall survival (OS) was not reached at the time of analysis. The presence of ≥ 5 bone metastases (hazard ratio HR 4.33; p = 0.015), non-gastroenteropancreatic (non-GEP) NETs (HR 3.22; p = 0.025) and development of interim ascites (HR 3.15; p = 0.047) independently predicted a worse OS. Patients with chromogranin A of ≥ 4 × upper limit of normal (ULN) had shorter OS (p < 0.001) and PFS (p = 0.004). Similarly, those with pre-existing ascites demonstrated a worse OS (p = 0.009) and PFS (p = 0.026). Liver metastases involving greater than 50% liver volume and the existence of unusual metastatic locations had a negative impact on OS (p = 0.033) and PFS (p = 0.026), respectively. CONCLUSION: High burden of skeletal and hepatic metastases, non-GEP-NETs, chromogranin A of ≥ 4 × ULN, unusual metastatic sites, pre-existing and interim ascites are predictors of poor outcomes in patients treated with 177Lu-Dotatate. These common indicators can be used for the risk stratification and identification of patients most likely to benefit from PRRT. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02236910, Retrospectively registered on September, 2014.

Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial.

GRAPHICAL ABSTARCT: PURPOSE: To report the results of the first-in-human trial evaluating the safety and efficacy of the percutaneous ultrasound gastrostomy (PUG) technique. METHODS: A prospective, industry-sponsored single-arm clinical trial of PUG insertion was performed in 25 adult patients under investigational device exemption (mean age 64 ± 15 years, 92% men, 80% inpatients, mean BMI 24.5 ± 2.7 kg/m2). A propensity score-matched retrospective cohort of 25 patients who received percutaneous radiologic gastrostomy (PRG) was generated as an institutional control (mean age 66 ± 14 years, 92% men, 80% inpatients, mean BMI 24.0 ± 2.7 kg/m2). Primary outcomes included successful insertion and 30-day procedure-related adverse events (AE's). Secondary outcomes included procedural duration, sedation requirements, and hospital length of stay. RESULTS: All PUG procedures were successful, including 3/25 [12%] performed bedside within the ICU. There was no significant difference between PUG and PRG in rates of mild AE's (3/25 [12%] for PUG and 7/25 [28%] for PRG, p = 0.16) or moderate AE's (1/25 [4%] for PUG and 0/25 for PRG, p = 0.31). There were no severe AE's or 30-day procedure-related mortality in either group. Procedural room time was longer for PUG (56.5 ± 14.1 min) than PRG (39.3 ± 15.0 min, p < 0.001). PUG procedure time was significantly shorter after a procedural enhancement, the incorporation of a Gauss meter to facilitate successful magnetic gastropexy. Length of stay for outpatients did not significantly differ (2.4 ± 0.5 days for PUG and 2.6 ± 1.0 days for PRG, p = 0.70). CONCLUSION: PUG appears effective with a safety profile similar to PRG. Bedside point-of-care gastrostomy tube insertion using the PUG technique shows promise. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID NCT03575754.

Retrievable inferior vena cava filter for primary prophylaxis of pulmonary embolism in at-risk trauma patients: A feasibility trial.

OBJECTIVE: To determine if insertion of rIVCF for PE prophylaxis in high risk trauma patients could result in a clinically meaningful reduction (>24 h) in time that patients are left unprotected from PEs SUMMARY AND BACKGROUND DATA: Trauma patients are at high risk for the development of pulmonary embolism (PE). Early pharmacologic PE prophylaxis is ideal, however many patients are unable to receive prophylaxis due to concomitant injuries. Current guidelines are conflicting on the role of prophylactic retrievable inferior vena cava filters (rIVCF) for PE prevention in this patient population, and robust data to guide clinicians is lacking. METHODS: In this single center, randomized control trial of adult (age > 18 years) trauma patients at high risk for PE by EAST criteria and unable to receive pharmacologic prophylaxis for at least 72 h, we randomized 42 patients to receive a rIVCF or to not have a rIVCF placed. Our primary endpoints were time left unprotected to PE development and feasibility. RESULTS: The median patient age was 53 years, with a median Injury Severity Score of 33. Randomization to rIVCF reduced the time left unprotected to PE (Control: 78.2 h [53.6-104]; rIVCF: 25.5 h [9.8-44.6], p = 0.0001). Two pulmonary embolisms occurred in the control group, and one in the rIVCF group. Seven deaths occurred in the control group, and 8 in the rIVCF group. CONCLUSION: This feasibility study demonstrates a clinically meaningful reduction in time left unprotected to PE. Further investigations powered to demonstrate a reduction in PE incidence are required. LEVEL OF EVIDENCE: Level 1 Evidence randomized controlled trial.

Percutaneous Cryoablation of Recurrent Pancreatic Mass for Life-Threatening Pancreatic VIPoma Syndrome: A Case Report.

We present the case of a 73-year-old female who underwent percutaneous cryoablation for recurrent life-threatening pancreatic vasoactive intestinal polypeptide-producing tumor (VIPoma) following a pancreaticoduodenectomy and chemotherapy 5 years earlier. She presented with profuse watery diarrhea causing severe electrolyte and acid-base abnormalities, along with acute kidney injury. Cryoablation was successful in treating her profound symptoms, completely reversing her clinical course. The patient has made a successful recovery for the last 1.5 years since the procedure.

Overall Impact of the COVID-19 Pandemic on Interventional Radiology Services: A Canadian Perspective.

PURPOSE: The aim of this national survey was to assess the overall impact of the coronavirus disease 2019 (COVID-19) pandemic on the provision of interventional radiology (IR) services in Canada. METHODS: An anonymous electronic survey was distributed via national and regional radiology societies, exploring (1) center information and staffing, (2) acute and on-call IR services, (3) elective IR services, (4) IR clinics, (5) multidisciplinary rounds, (6) IR training, (7) personal protection equipment (PPE), and departmental logistics. RESULTS: Individual responses were received from 142 interventional radiologists across Canada (estimated 70% response rate). Nearly half of the participants (49.3%) reported an overall decrease in demand for acute IR services; on-call services were maintained at centers that routinely provide these services (99%). The majority of respondents (73.2%) were performing inpatient IR procedures at the bedside where possible. Most participants (88%) reported an overall decrease in elective IR services. Interventional radiology clinics and multidisciplinary rounds were predominately transitioned to virtual platforms. The vast majority of participants (93.7%) reported their center had disseminated an IR specific PPE policy; 73% reported a decrease in case volume for trainees by at least 25% and a proportion of trainees will either have a delay in starting their careers as IR attendings (24%) or fellowship training (35%). CONCLUSION: The COVID-19 pandemic has had a profound impact on IR services in Canada, particularly for elective cases. Many centers have utilized virtual platforms to provide multidisciplinary meetings, IR clinics, and training. Guidelines should be followed to ensure patient and staff safety while resuming IR services.

The Canadian Association for Interventional Radiology (CAIR) and Canadian Association of Radiologists (CAR) Guidelines for Interventional Radiology Procedures for Patients With Suspected or Confirmed COVID-19.

The current coronavirus disease 2019 (COVID-19) pandemic is creating significant challenges to the Canadian health system, including the practice of interventional radiology (IR). Interventional radiology will continue to play an important role in patient care, during this crisis. This document serves to guide interventional and general radiologists in safely performing IR procedures on patients with suspected or confirmed COVID-19, using the best evidence, guidelines and expert recommendations available. These strategies include reviewing procedural indications, development of tactics to minimize cross contamination prior to the intervention, appropriate usage of personal protection equipment according to the type of procedure (along with defining aerosol-generating procedures in IR), along with developing the appropriate work environment during the COVID-19 pandemic. By adopting the policies described, hospitals will protect the interventional radiologists, medical radiation technologists, nurses, ancillary staff, along with patients who benefit from their care.

Percutaneous Ultrasound Gastrostomy: First-in-Human Experience with the PUMA-G System.

Percutaneous ultrasound gastrostomy (PUG) technique was developed to allow for gastrostomy tube insertion to be performed solely under ultrasound guidance without need for fluoroscopy or endoscopy. This report discusses the new device, proposed PUG technique, and the first-in-human experience. Five patients had PUG tube insertion performed as part of a Health Canada approved investigational study. All procedures were successful with no complications within 30 days postprocedure. Mean total procedure time was 50 ± 13 minutes. Two of 5 procedures required temporary fluoroscopy use to localize the orogastric balloon position within the stomach to achieve magnetic gastropexy.

Efficacy of 177Lu-Dotatate Induction and Maintenance Therapy of Various Types of Neuroendocrine Tumors: A Phase II Registry Study.

Peptide receptor radionuclide therapy (PRRT) has been recently established as a treatment option for progressive gastro-entero-pancreatic neuroendocrine tumors (NETs) including four 200 mCi induction cycles. The purpose of this phase 2 trial is to expand use of PRRT to different types of NETs with the application of dose adjustment and evaluate value of maintenance therapy in patients who had disease control on induction therapy. Forty-seven PRRT naïve NET patients with different primary origin received 177Lu-DOTATATE induction therapy, ranging from 75 to 150 mCi per cycle, based on patients' clinical status such as liver and renal function, extent of metastases, and previous therapies. Thirty-four patients underwent additional maintenance therapy (50-100 mCi per cycle) following induction course until they developed disease progression. The estimated median progression-free survival (PFS) was 36.1 months. The median PFS in our MNET subgroup was 47.7 months, which is markedly longer than NETTER-1 trial with median PFS of 28.4 months. The median PFS was significantly longer in patients who received PRRT as first-line treatment after disease progression on somatostatin analogs compared to patients who received other therapies first (p-value = 0.04). The total disease response rate (DRR) and disease control rate (DCR) was 32% and 85% based on RECIST 1.1 and 45% and 83% based on Choi criteria. This trial demonstrates longer PFS with the addition of low dose maintenance therapy to induction therapy compared to NETTER-1 trial that only included induction therapy. Also, we observed considerable efficacy of PRRT in various types of advanced NETs.

Interventional Radiology in Canada: Current Challenges and Future Directions.

OBJECTIVE: We aim to define the practice of interventional radiology (IR) in Canada, barriers that have been faced by interventional radiologists, and ways in which the Canadian Interventional Radiology Association (CIRA) have attempted to address these issues. CONCLUSION: IR has faced significant challenges in the Canadian setting. Recognizing the need to address these challenges, leaders in the field of IR in Canada founded the CIRA to serve as our national voice and lobby group.

Thirty-day complication rate of percutaneous gastrojejunostomy and gastrostomy tube insertion using a single-puncture, dual-anchor technique.

PURPOSE: Our objective was to assess 30-day mortality and complication rates associated with percutaneous enteral feeding tube insertion using a single-puncture, dual-suture anchor gastropexy and peel-away sheath technique. We explored differences in complications based on indication and gastrostomy versus gastrojejunostomy tube. METHODS: A retrospective review was conducted of adult patients undergoing fluoroscopically guided gastrojejunostomy (GJ) and gastrostomy (G) tube insertions between July 2011 and 2014 by five interventional radiologists at a single tertiary care centre. A single-puncture dual-anchor gastropexy technique with a peel-away sheath was used for all patients. Complications within 30 day post-procedure were classified based on the Society of Interventional Radiology Standards of Practice for Gastrointestinal Access. Procedure-related mortality and complication rates, as well as indication-specific complication rates, were compared between GJ and G groups. RESULTS: 559 consecutive patients underwent G (86) or GJ (473) tube insertion. Primary technical success was 100%. Nine major (1.6%) and 60 minor (10.7%) complications occurred for an overall complication rate of 12.3%. The 30-day complication rate was significantly higher for GJ compared to G tube insertion (13.5% v. 5.8%, p = .049). There was a trend toward a higher 30-day minor complication rate for the GJ group (11.8% v. 4.7%, p = .057), but no significant difference between groups with respect to major complications (1.7% v. 1.2%, p = 1.0). Four procedure-related deaths occurred resulting in an overall procedure-related mortality of 0.7%. No significant difference in the procedure-related mortality was found between GJ and G groups (0.6% v. 1.2%, p = .49). CONCLUSION: The 30-day major complication and procedure-related mortality rates from G and GJ tube insertion are low when using a single-puncture, dual-anchor gastropexy technique. GJ tube insertion is associated with a higher overall complication rate, likely due to more minor complications, but may avoid long-term adverse events.

Informed Consent for Radiation in Interventional Radiology Procedures.

PURPOSE: To explore the patient perception on radiation-related cancer risk from interventional radiology (IR) procedures and whether informed radiation consent is warranted. METHODS: A multiple-choice survey was prospectively administered to 68 adults undergoing a body or neuro-IR procedure with ionizing radiation exposure. Subgroup analysis with chi-square or Fisher exact test was performed based on patient past IR history (P < .05). RESULTS: A total of 81% of patients wanted to be informed if there was a radiation-related 3% increased cancer risk over 5 years. Although 55% considered 3% a small risk, 28% wanted to further discuss the risks and alternate options, and 15% would have only proceeded if it were a life-saving procedure: 89%, 80%, and 67% of patients wanted to be informed with exposure risks of 1 in 100, 1 in 1000, and 1 in 10,000, respectively. Only 53% were aware they were going to be exposed to radiation, irrespective of past IR history (P = .15). Most patients believed radiation consent should include radiation-related cancer risks (85%). No past IR history was significantly associated with wanting consent to include cancer-related risk (100% vs 76%; P = .01) and deterministic risks (70% vs 41%; P = .04). A majority (69%) believed both the referring physician and the interventional radiologist were responsible for obtaining radiation consent, and 65% of patients wanted verbal consent followed by signed written consent, regardless of past IR history. CONCLUSIONS: Many patients want to discuss cancer-related radiation risks with both radiologists and physicians. Informed radiation consent should be considered for procedures with high anticipated radiation doses.