Clinical Trials in Hepatopancreatobiliary Surgery: Assessing Trial Characteristics, Early Discontinuation, Result Reporting, and Publication.

BACKGROUND: Hepatopancreaticobiliary (HPB) diseases carry high morbidity despite efforts aimed at their reduction. An assessment of their trial characteristics is paramount to determine trial design adequacy and highlight areas for improvement. As such, the aim of this study is to assess HPB surgery trial characteristics, summarize logistic, financial, and practical reasons behind early discontinuation, and propose potential interventions to prevent this in the future. METHODS: All clinical trials investigating HPB surgery registered on ClinicalTrials.gov from October 1st, 2007 (inclusive), to April 20th, 2021 (inclusive), were examined. Trial characteristics were collected including, but not limited to, study phase, duration, patient enrollment size, location, and study design. Peer-reviewed publications associated with the selected trials were also assessed to determine outcome reporting. RESULTS: A total of 1776 clinical trials conducted in 43 countries were identified, the majority of which were conducted in the USA. Of these trials, 32% were reported as "completed" whereas 12% were "discontinued." The most common cause of trial discontinuation was low accrual, which was reported in 37% of terminated studies. These resulted in 413 published studies. Most trials had multiple assignment, randomized, or open-label designs. Treatment was the most common study objective (73%) with pharmacological therapy being the most commonly studied intervention. CONCLUSIONS: The main reasons for early discontinuation of clinical trials in HPB surgery are poor patient recruitment and inadequate funding. Improved trial design, recruitment strategies and increased funding are needed to prevent trial discontinuation and increase publication rates of HPB surgery clinical trials.

Distribution of international medical graduates across USA surgical training programs: a descriptive cross-sectional study.

BACKGROUND: International medical graduates (IMGs) have been a critical part of the USA healthcare in the past 30 years, especially in small rural and poor counties. However, little to no publications are present on the distribution of these IMGs across general surgery residency programs. METHODS: All freely accessible information on current residents in accredited general surgery residency programs within the USA with at least a 5-year history was explored for IMGs in the current roster using the AMA residency and fellowship database in 2020. Demographic and geographic data were summarized. RESULTS: A total of 230 general surgery residency program were included. Programs were distributed among 46 (92%) states. Of a total 6304 categorical general surgery residents, 573 (9%) were IMGs. Florida (USA) had the highest total number of current IMG general surgery residents with 64. The highest percentage of current IMG residents was found in Maryland (USA) with 31%. IMGs obtained their medical degrees from 76 different countries worldwide. Grenada was the country with the highest origin of IMGs with 77 residents. Central/North America had the highest origin of IMGs with 217 (38%). CONCLUSIONS: IMGs make up a small portion of current general surgery residents in USA programs. Some states host more IMGs than others. Particular countries have contributed more IMGs than others. More research is needed to the challenges facing IMGs and come up with novel solutions for them.

Preoperative MELD score predicts adverse outcomes following gastrectomy: An ACS NSQIP analysis.

BACKGROUND: The Model End-Stage Liver Disease (MELD) has been widely used to predict the mortality and morbidity of various surgical procedures. We aimed to assess the impact of preoperative MELD score on adverse 30-day postoperative outcomes following gastrectomy. METHODS: Patients who underwent elective, non-emergent gastrectomy were identified from the ACS NSQIP 2014-2019 database. Patients were categorized according to a calculated MELD score. The primary outcomes of this study were the 30-day overall complications and major complication rates following gastrectomy. RESULTS: Compared to MELD <11, patients with MELD ≥11 had significantly higher rates of mortality, any complication, and major complication. MELD score ≥11 was significantly associated with any complication (OR 1.73, p = 0.011) and major complications (1.85, p = 0.014) on multivariate analysis. CONCLUSIONS: MELD score ≥11 was associated with poorer outcomes in patients undergoing gastrectomy compared to lower MELD scores.

Locoregional options in the management of cholangiocarcinoma: single center experience.

BACKGROUND: The purpose of this case series is to assess the safety and efficacy, as well as the overall survival (OS) and progression free survival (PFS) of patients with intrahepatic cholangiocarcinoma (ICC) treated with percutaneous ablation, transarterial arterial chemoembolization (TACE) or a combination of both at our institution. METHODS: Ten patients with pathological diagnosis of adenocarcinoma treated at out institution between January 1st 2013 and January 1st 2019 were reviewed. Three patients received a combined TACE and ablation treatment, three patients received TACE without ablation and four patients were treated with ablation only. Ablation technical success was determined by absence of residual tumor in the ablation zone on follow-up imaging one-month post-ablation. TACE response was assessed using the Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Technical success was defined as injection of chemoembolic material in the involved liver lobes. PFS and OS were calculated from the date of diagnosis. RESULTS: In the TACE and radiofrequency ablation (RFA) group, OS was 12, 55 and 56 months; PFS was 5, 6 and 32 months, one patient died and two others remain alive. In the TACE group, OS was 29, 10 and 5 months; PFS was 15, 10 and 4 months. All three patients remain alive. In the ablation group, OS and PFS were 16, 31, 30 and 40 months. All patients remain alive. Overall, 9 of 10 patients are alive, with a Median OS and PFS of 29.5 and 15.5 months, respectively, with some patients remain alive over four years following initial presentation. CONCLUSIONS: Our study shows that ablation and TACE in combination with more traditional modalities such as chemoradiation and surgical resection can extend survival in patients with ICC significantly. Locoregional therapy is well tolerated with only minor adverse events. The use of stereotactic body radiation therapy (SBRT) with ablation demonstrated the synergistic nature of using multiple lines of interventions.

Cancer in Lebanon: A Review of Incidence Rates from 2008 to 2015 and Projections Till 2025.

Background and Objectives Cancer carries one of the heaviest burdens globally in terms of mortality. Lebanon is a middle-income Middle East country also plagued with cancer, as such a study and analysis of cancer trends and projections would serve a great benefit in the fight against the disease. Materials and Methods All data pertaining to cancers in Lebanon were extracted from the National Cancer Registry of Lebanon Web site. Data were analyzed to produce trends over the years of our study (2008-2015). Ten-year projections were further calculated for the top cancers by the primary site using logarithmic models. Results The top cancers in Lebanon are the breast, lung, colorectal, bladder, and prostate. The top cancers affecting females are the breast, lung, and colorectal. The top cancers affecting males are the prostate, lung, and bladder. Cancer cases are projected to increase in Lebanon over the next 10 years. Conclusion Lebanon had a steady incidence rate of cancer cases during the time of our study. A more complete understanding of cancer trends and their ultimate reduction will require further research into the origins of specific cancers and the means of prevention and control.