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.

Robotic pancreas surgery: an overview of history and update on technique, outcomes, and financials.

The use robotics in surgery is gaining momentum. This approach holds substantial promise in pancreas surgery. Robotic surgery for pancreatic lesions and malignancies has become well accepted and is expanding to more and more center annually. The number of centers using robotics in pancreatic surgery is rapidly increasing. The most studied robotic pancreas surgeries are pancreaticoduodenectomy and distal pancreatectomy. Most studies are in their early phases, but they report that robotic pancreas surgery is safe feasible. Robotic pancreas surgery offers several advantages over open and laparoscopic techniques. Data regarding costs of robotics versus conventional techniques is still lacking. Robotic pancreas surgery is still in its early stages. It holds promise to become the new surgical standard for pancreatic resections in the future, however, more research is still needed to establish its safety, cost effectiveness and efficacy in providing the best outcomes.

Comparison of the Oxygenation Factor and the Oxygenation Ratio in Subjects With ARDS.

BACKGROUND: The oxygenation ratio (ie, [Formula: see text]/[Formula: see text]) remains the most commonly used index for assessing oxygenation and disease severity in patients with acute ARDS. However, the oxygenation ratio does not account for mechanical ventilation settings. We hypothesized that the oxygenation factor (ie, oxygenation ratio/mean airway pressure) is superior to the oxygenation ratio in reflecting oxygenation in patients with ARDS and results in a different classification of ARDS severity. METHODS: In 150 subjects with ARDS (50 severe, 50 moderate, and 50 mild), arterial blood gas, mean airway pressure, static lung compliance, driving pressure, and mechanical power were obtained. The oxygenation ratio and the oxygenation factor were then calculated. Receiver operating characteristic curves were constructed for oxygenation ratio and oxygenation factor at lung compliance > 40 mL/cm H2O, driving pressure < 15 cm H2O, and mechanical power < 17 J/min, thresholds that are known to predict survival in patients with ARDS. Subjects were reclassified for ARDS severity on the basis of the oxygenation factor and compared to classification on the basis of the oxygenation ratio. RESULTS: Areas under the receiver operating characteristic curves for the oxygenation factor were significantly higher than for the oxygenation ratio. Reclassification of ARDS severity using the oxygenation factor did not affect subjects classified as having severe ARDS per the oxygenation ratio. However, 52% of subjects with moderate ARDS per the oxygenation ratio criteria were reclassified as either severe (25 subjects) or mild ARDS (1 subject) on the basis of oxygenation factor criteria. Also, 54% of subjects with mild ARDS per the oxygenation ratio criteria were reclassified as severe (4 subjects), moderate (21 subjects), or non-ARDS (2 subjects) on the basis of oxygenation factor criteria. CONCLUSIONS: The oxygenation factor was a superior ARDS oxygenation index compared to the oxygenation ratio and should be considered as a substitute criteria for classification of the severity of ARDS. (ClinicalTrials.gov registration NCT03946189.).

Splenic Artery Aneurysm (SAA) Rupture in Pregnancy: A Case Report of a Rare but Life-Threatening Obstetrical Complication.

This is the case of a 38 year-old Lebanese woman G2P1, history of previous cesarean section, presenting at 30+5 weeks of gestation with acute left-sided flank pain and a two-day history of chills and dysuria. In light of the clinical presentation, the patient was initially diagnosed with pyelonephritis and managed accordingly; however, her clinical status deteriorated with worsening hypotension and lethargy despite resuscitative measures and a normal abdominal ultrasound. Failure to revive the patient eventually led to a cardiac arrest for which a peri-mortem cesarean section was performed at bedside. Upon abdominal entry, an actively-bleeding ruptured splenic artery aneurysm (SAA) was identified, for which massive transfusion protocol was activated, and the patient was transferred to the operating room. The patient had a complicated postoperative course, the fetus was stillborn, and she was discharged home after 6 months of hospital stay. In view of the high mortality and morbidity associated with ruptured SAA in pregnancy, early recognition and prompt intervention are crucial for maternal and fetal benefit.

Large esophageal schwannoma: En-bloc resection with primary closure by esophagoplasty.

BACKGROUND: Gastrointestinal schwannomas are submucosal tumors accounting for 2-7% of mesenchymal gastro-intestinal neoplasms; the stomach being the most common site. Esophageal schwannomas are more frequent in women, and are usually located in the upper to mid portion. Dysphagia is the main presenting symptom. A definitive diagnosis requires confirmation by histopathological and immunohistochemical studies. CASE PRESENTATION: A 50-year-old healthy lady, presented with gradual increasing onset of dyspnea, with minimal dysphagia to solid food, over a period of several years. Enhanced CT scan of the chest revealed a well-defined soft tissue mass arising from the proximal third of the esophagus, measuring 7.8 × 5.4 x 10.5 cm. Esophagogastric endoscopy with ultrasonography showed an elevated, smooth surface lesion, arising from the submucosal layer of the esophagus, with a hypervascular mucosa. Enucleation of this large tumor, with preservation of the overlying mucosa, was difficult to accomplish due to its large size. Making use of a dilated proximal esophageal segment, total en-bloc excision of the mass rendered a 15 cm esophagotomy gap, which was easily closed, in two layers, without affecting the overall caliber thus achieving a good esophagoplasty result. Histologically, abundance of spindle-shaped cells with positive S-100 proteins, confirmed the diagnosis of esophageal schwannoma. CONCLUSION: Variations in mesenchymal gastrointestinal tumors is vast, rendering diagnosis by radiology alone difficult. As such, characteristic histologic and immunostaining features are cornerstones in precise diagnosis of esophageal schwannomas. Despite being rare in incidence, symptomatic esophageal schwannoma lesions can be excised entirely, with low rate of recurrence and favorable overall outcomes.

Pancreaticoduodenal Artery Aneurysm Associated with Celiac Trunk Stenosis: Case Illustration and Literature Review.

Pancreaticoduodenal artery aneurysms (PDA) are rare visceral aneurysms. Celiac trunk stenosis represents a common attributable aetiology for those aneurysms. Therefore, an alternative treatment approach, which differs from those isolated aneurysms, is recommended. We hereby present a 77-year-old male patient who was admitted with sudden onset of severe abdominal pain and significant drop in haemoglobin, occurring within a 24-hour interval. Contrast-enhanced computed tomography revealed a ruptured visceral aneurysm arising from the anterior branch of the inferior pancreaticoduodenal artery. A severe stenosis was also noted at the take-off of the celiac trunk. Selective catheterization of the supplying branch of the superior mesenteric artery, followed by coil embolization of the aneurysm, was performed, resulting in cessation of flow within the aneurysm, with preservation of the posterior branch, supplying the celiac territory. PDAs are usually asymptomatic and discovered incidentally at rupture. The risk of rupture is independent of the aneurysmal size and is associated with a 50% mortality rate. The consensus on coping with aneurysms is to treat them whenever they are discovered. Selective angiography followed by coil embolization represents a less invasive, and frequently definitive, approach than surgery. The risk for ischemia mandates that the celiac territory must not be compromised after embolization.

Perforated Duodenal Diverticulum Treated Conservatively: Another Two Successful Cases.

Diverticula of the duodenum proceed those of the colon in respect to frequency of location. Incidence at times of autopsy ranges from 15 to 23%. Despite the fact that more than 90% of duodenal diverticulum cases are asymptomatic, complications if they do occur can be calamitous. Perforation is one of these rare complications. Surgical intervention has always been the mainstay for symptomatic/complicated duodenal diverticula, but with the advancement of imaging, medical treatment, and proper intensive observation, conservative treatment came forth. We hereby present two cases of duodenal diverticula, complicated by perforation and fistulization into the retroperitoneal cavity, both treated conservatively by Taylor's approach of upper gastrointestinal tract perforation. Review of other cases of duodenal diverticulum perforation has also been presented.

Nasogastric Tube Feeding-Induced Esophageal Bezoar: Case Description.

Background. Bezoars are well established entities causing gastrointestinal obstructions. Depending on the prominent constituent of these bezoars, the latter are divided into four subtypes: pharmacobezoars, lactobezoars, trichobezoars, and phytobezoars. Less frequently reported types of bezoars are reported including those formed secondary to nasogastric tube feeding with casein-based formulas. Case Presentation. A 69-year-old male presented following cardiac arrest postmyocardial infarction. Patient sustained anoxic brain injury after resuscitation, rendering him ventilator dependant along with nasogastric tube feeding, initially. Dislodging of the nasogastric tube at one time rendered it difficult to reinsert it, with investigation showing the presence of calcified material within the distal oesophagus, mainly composed of casein-based products secondary to enteral feeding. Conclusion. Bezoars are well known to cause gastrointestinal obstructions due to their indigestible characteristics within the alimentary tract. More rare causes of bezoars include those formed from casein-based feeding formulas administered to patients with sustained enteral feeding. Esophageal obstruction, secondary to casein-based bezoars, occurs due to multiple risk factors, especially in those necessitating intensive care. Approach in such scenarios requires a multiteam approach.

Sigmoid to scrotal fistula secondary to mesh erosion: a rare complication of inguinal hernia repair in a patient on anticoagulation.

BACKGROUND: Few reports from the medical literature have presented severe mesh-related complications following laparoscopic repair of inguinal hernia. One of these complications is being mesh erosion into bowel, resulting in fistulous tract with subsequent abscess formation. CASE PRESENTATION: A 75-year-old patient, status post laparoscopic bilateral inguinal hernia repair, and on anticoagulation for dual prosthetic heart valves, presented with a unique case of sigmoid to scrotal fistula, post mesh erosion, resulting in sepsis. The patient presented in septic shock, necessitating an individualized surgical approach. Given the septic picture of our patient, the surgical approach was truncated. Initially the sepsis from the scrotum was drained and debrided. A watermelon seed was noted in the scrotum. After stabilization, the second stage approach was performed, were a laparotomy was performed, followed by division of the sigmoid to internal ring fistula, and reperitonealization of the mesh. Mesh removal was delayed as the risk of bleeding into the peritoneum was high, once anticoagulation needed to be resumed. Because of a persistent wound sinus tract, several months later, the mesh was removed, in a third stage, from an inguinal incision. Albeit meticulous dissection and homeostasis, a postoperative extraperitoneal inguinal hematoma developed, as expected, on day 2, once anticoagulation was resumed. CONCLUSION: Sigmoid to inguinoscrotal fistula is a rare, yet serious, complication of mesh infection and erosion. This can be obviated by preventing serosal tear, and proper peritonealization of the mesh. Fistulectomy alone with primary repair turned out to be a valid approach in our patient. Retaining the mesh could be an alternative for avoiding bleeding in patients on anticoagulation; despite that a persistent indolent infection and sinus tract will necessitate mesh removal afterwards.

Magnetic resonance cholangiopancreatography accurately detects common bile duct stones in resolving gallstone pancreatitis.

BACKGROUND: There is controversy about the optimal method to detect common bile duct (CBD) stones in patients with mild resolving gallstone pancreatitis. The aim of this study was to evaluate magnetic resonance cholangiopancreatography (MRCP) in detecting choledocholithiasis in this group of patients. STUDY DESIGN: A prospective randomized trial was conducted. Patients randomized to group 1 (n = 34) underwent laparoscopic cholecystectomy (LC) and intraoperative cholangiography (IOC). Those randomized to group 2 (n = 29) had preoperative MRCP, of these, patients with negative MRCP underwent LC and IOC, patients with positive MRCP had preoperative ERCP followed by LC. RESULTS: Sixty-three patients were randomized (34 to group 1 and 29 to group 2). CBD stones were found in 5 patients in group 1. CBD exploration was performed in 2 patients, preoperative ERCP in 1, and postoperative ERCP in the other 2. MRCP showed CBD stones in 4 patients in group 2. There were two false-positive MRCPs. Four patients with a negative MRCP did not have IOC or ERCP, the remaining 21 patients with a negative MRCP had a negative IOC. The MRCP sensitivity was 100% (95% CI, 16-100%), specificity 91% (95% CI, 72-99%), positive predictive value 50% (95% CI, 7-93%), negative predictive value 100% (95% CI, 84-100%), and accuracy 92% (95% CI, 74-99%). CONCLUSIONS: Patients with resolving gallstone pancreatitis and a negative MRCP do not need preoperative ERCP or IOC. Only patients with a positive MRCP will require preoperative ERCP.