Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial.

Importance: Infection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level disinfection to completely eliminate microorganisms on the instrument. Objective: To determine (1) contamination rates after high-level disinfection and (2) technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs. Design, Setting, and Participants: In this parallel-arm multicenter randomized clinical trial at 2 tertiary ERCP centers in Canada, all patients 18 years and older and undergoing ERCP for any indication were eligible. Intervention: The intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design. Main Outcomes and Measures: Coprimary outcomes were persistent microbial contamination of the duodenoscope elevator or channel, defined as growth of at least 10 colony-forming units of any organism or any growth of gram-negative bacteria following high-level disinfection (superiority outcome), and technical success of ERCP according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers. Results: From December 2019 to February 2022, 518 patients were enrolled (259 disposable elevator cap duodenoscopes, 259 standard duodenoscopes). Patients had a mean (SD) age of 60.7 (17.0) years and 258 (49.8%) were female. No significant differences were observed between study groups, including in ERCP difficulty. Persistent microbial contamination was detected in 11.2% (24 of 214) of standard duodenoscopes and 3.8% (8 of 208) of disposable elevator cap duodenoscopes (P = .004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75) and number needed to treat of 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination. Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs 90.7%, P = .13). There were no differences between study groups in adverse events and other secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, disposable elevator cap duodenoscopes exhibited reduced contamination following high-level disinfection compared with standard scope designs, without affecting the technical performance and safety of ERCP. Trial Registration: ClinicalTrials.gov Identifier: NCT04040504.

Plasma bupivacaine levels (total and free/unbound) during epidural infusion in liver resection patients: a prospective, observational study.

INTRODUCTION: Liver resection patients may be at an increased risk of local anesthetic (LA) toxicity because the liver is essential for metabolizing LA and producing proteins (mainly α1-acid glycoprotein (AAG)) that bind to it and reduce the free (and pharmacologically active/toxic) levels in circulation. The liver resection itself, manipulation during surgery, and pre-existing liver disease may all interfere with normal hepatic protein synthesis and result in an attenuation of the increased AAG (a positive acute-phase protein) that normally occurs postoperatively. The purpose of this study was to determine whether the AAG response is attenuated postoperatively following liver resection and whether patients approach toxicity thresholds with continuous postoperative epidural infusion of bupivacaine. METHODS: Prospective, observational study with blood drawn preoperatively, in the postanesthetic care unit, on postoperative day (POD) 2, and prior to discontinuation of epidural analgesia on POD3/POD4. Plasma was analyzed for total and unbound bupivacaine via liquid chromatography-mass spectrometry and AAG via ELISA. Signs/symptoms of local anesthetic systemic toxicity (LAST), pain, and sedation scores were also recorded. RESULTS: For the 19 patients completed, total plasma bupivacaine was correlated with total administered, but unbound levels were not associated with the total administered. Unlike non-hepatectomy surgery where unbound LA plasma levels remain stable (or decrease) with continuous postoperative epidural administration, we observed an overall increase. Several patients approached toxicity thresholds and 47% reported at least one symptom of LAST, but no epidurals were discontinued because of LAST. In contrast to the AAG response reported following major non-liver surgery where AAG levels increase twofold, we observed a reduction until POD2 and the magnitude was proportional to resection weight. DISCUSSION: Our results are supported by the literature in suggesting that major liver resection patients may be at an increased vulnerability for LAST. Factors such as the extent of liver disease, resection and intraoperative blood loss should be considered when using continuous postoperative epidural infusion of bupivacaine and vigilance should be used in monitoring, for signs/symptoms of LAST, even for those subtle and non-specific. Future research will be required to verify these findings. TRIAL REGISTRATION NUMBER: NCT03145805.

Competency-based education in general surgery: Are Canadian residents ready?

Summary: Competency-based education (CBE) is currently being implemented by the Royal College of Physicians and Surgeons of Canada across all residency programs. This shift away from time-based residency is proposed to be the answer to maximize training opportunity in the era of work hour restrictions and growing concerns regarding accountability in medical education. A Web-based survey was conducted to obtain feedback from Canadian general surgery residents on their experience and perception of competence within core procedures, as well as attitudes toward CBE. A total of 244 residents completed the survey. For most procedures, more than 50% of residents felt they could perform the procedure with no guidance after completing 11-30 cases. Generally, residents were welcoming of CBE; however, medium-sized programs reported some concerns regarding inadequate exposure to cases and risk of training less well-rounded surgeons. This is valuable resident feedback for programs to consider during the implementation process.

Effect of PET-CT on disease recurrence and management in patients with potentially resectable colorectal cancer liver metastases. Long-term results of a randomized controlled trial.

BACKGROUND: Preoperative evaluation of resectable colorectal cancer liver metastases with positron emission tomography (PET) combined with computed tomography (PET-CT) is used extensively. The PETCAM trial evaluated the effect of PET-CT (intervention) vs no PET-CT (control) on surgical management. PET-CT resulted in 8% change in surgical management, therefore, we aimed to compare long-term outcomes (disease-free [DFS], overall survival [OS]). METHODS: Trial recruitment (2005-2010) had prospective follow-up until 2013. Events from 2013 to 2017 were collected retrospectively. Survival was described by the Kaplan-Meier method and compared with log-rank test. Oncologic risk factors were calculated using Cox proportional hazard models. RESULTS: Among 404 patients randomized, there were no differences in DFS (hazard ratio [HR] = 1.13; 95% confidence interval [CI], 0.89 to 1.43) or OS (HR, 1.02; 95% CI, 0.78-1.32) between groups. For all patients randomized, median DFS (PET-CT vs no PET-CT) was 16 months (95% CI, 13-18) and 15 months (95% CI, 11-22), P = .33. For patients who underwent liver resection (n = 368), DFS (17 vs 16 months, P = .51) and OS (58 months vs 52 months, P = .90) were similar between groups, respectively. Risk factors for DFS and OS were age, tumor size, node-positive disease, extrahepatic metastases and disease-free duration. CONCLUSION: Preoperative PET-CT changes surgical management in a small percentage of cases, without effect on recurrence rates or long-term survival.

Implementation and evaluation of a comprehensive proficiency-based curriculum in an advanced, minimally invasive procedure: a multi-institutional Canadian experience.

INTRODUCTION: A comprehensive proficiency-based curriculum for an advanced, minimally invasive procedure was previously developed and shown to be more educationally effective than conventional surgery training. OBJECTIVE: To implement and evaluate this proficiency-based curriculum in 2 academic general surgery residency programs in Canada. SETTING: Two academic, general surgery residency programs at university hospitals in Ontario, Canada. METHODS: An 8-week, proficiency-based curriculum consisted of a didactic component (lectures, small group sessions, assigned readings) and a simulation-based component (proficiency-based training in laparoscopic enteroenterostomy and a simulated operating room crisis scenario). It was offered to postgraduate years 2-5 general surgery residents in 2 academic programs in Canada. Pre- and postcurriculum procedure-specific knowledge and psychomotor skills were assessed using a 25-item knowledge test and a procedure-specific assessment scale. Postcurriculum nontechnical skills were assessed using the Nontechnical Skills for Surgeons scale. Participants' perceptions about the curriculum were assessed using a questionnaire. Direct costs for curriculum implementation were recorded. RESULTS: Twenty-five residents participated in the curriculum across 2 programs. Completion of the curriculum resulted in significant improvement in technical skills (45 [37.5-65] versus 88 [85-93]; P < .01) and demonstration of "acceptable" situational awareness (3 [3-4]), decision-making (3 [3-4]), teamwork and communication (3 [2-4]), and leadership (3 [3-4]) skills. There was no improvement in procedure-specific knowledge (48 [40-64] versus 58 [48-60]; P = .39). Participants perceived all components of the curriculum as educationally valuable, and 96% agreed and/or strongly agreed that this curriculum should continue to be a part of academic curriculum. The average cost of curriculum implementation was $613.05 Canadian dollars per participant. Lack of faculty supervision was the main barrier to implementation with only 65% of participants agreeing and/or strongly agreeing that quantity of faculty supervision was optimal. CONCLUSIONS: A comprehensive proficiency-based curriculum for an advanced, minimally invasive procedure was successfully implemented and evaluated at 2 academic general surgery residency programs in Canada. Adequate faculty preceptor resources are essential for widespread implementation.

Risk factors for survival following recurrence after first liver resection for colorectal cancer liver metastases.

BACKGROUND: Management of recurrence following liver resection for colorectal cancer metastases is a topic of debate. We determined risk factors for survival following recurrence after liver resection. METHODS: Long-term follow-up of patients in the PETCAM trial who had recurrence following liver resection. Risk groups were created according to their survival risk. Differences in overall survival (OS) between groups were estimated. Disease-free survival (DFS), patterns of disease recurrence and management were determined. Cox proportional hazard models, Kaplan-Meier method, and the log-rank test were used. RESULTS: Among 368 patients who underwent liver resection, 264 (72%) experienced disease recurrence (51% lung and 41% liver). Following liver resection, DFS: 17 months (95% CI, 14-19); OS: 57 months (95% CI, 46-70). In those who recurred, 120 (45%) received chemotherapy only, and 112 (42%) underwent second surgical resection. Among patients who experienced recurrence (n = 264), the high-risk group (more than one site of recurrence or disease-free duration < 5 months and node-positive disease) had median OS: 19 months (95% CI, 15-23) vs 36 months (95% CI, 30-48) for patients in the low-risk group (HR = 2.9, 95% CI, 2.2-3.9). CONCLUSION: Recurrence following liver resection is common. Following recurrence after liver resection, patients should be carefully selected for surgical re-resection based on risk factors.

Clinical Outcomes After Pulmonary Metastasectomy for Melanoma: A Population-Based Study.

BACKGROUND: Resection of pulmonary metastases is an important treatment option for patients with oligometastatic melanoma. There are currently no published data available on population-level outcomes. Here, we report outcomes of a registry-based study of patients who underwent lung resection for cutaneous melanoma metastases. METHODS: The study population was all cases of cutaneous melanoma in Ontario, Canada, with resection of pulmonary metastases from 2004 to 2012. Melanoma cases were identified using the population-based Ontario Cancer Registry and were linked with hospital records to identify thoracic surgery. Pathology reports from the Ontario Cancer Registry were used to confirm the histology of resected lesions and determine tumor-related prognostic factors. Overall survival was described, and multivariable Cox regression utilized. RESULTS: Ninety-nine patients underwent resection of cutaneous melanoma lung metastases. Mean age was 58 years. Sixty-day postoperative mortality was 0%. Two-year and 5-year overall survival from time of resection was 44% and 21%, respectively (95% confidence intervals: 34% to 54% and 12% to 31%, respectively). Two-year overall survival was 57% for lesion size less than 1.5 cm; 43% for lesion size 1.5 to 2.2 cm; and 35% for lesion size 2.2 cm or greater (confidence intervals: 35% to 73%, 26% to 59%, and 19% to 52%, respectively). In the multivariable stepwise selected model, the only significant variable was size 2.3 cm or greater (hazard ratio 1.64, confidence interval: 1.001 to 2.68). Greater lesion size was correlated with positive margin status (p = 0.04); there were no survivors beyond 2 years with positive margins. CONCLUSIONS: In this unselected population-based study, 21% of patients were 5-year survivors after pulmonary metastasectomy for melanoma. There was worse survival with greater lesion size. Greater lesion size was associated with positive margin status.

Utility of 3D Reconstruction of 2D Liver Computed Tomography/Magnetic Resonance Images as a Surgical Planning Tool for Residents in Liver Resection Surgery.

OBJECTIVE: A fundamental aspect of surgical planning in liver resections is the identification of key vessel tributaries to preserve healthy liver tissue while fully resecting the tumor(s). Current surgical planning relies primarily on the surgeon's ability to mentally reconstruct 2D computed tomography/magnetic resonance (CT/MR) images into 3D and plan resection margins. This creates significant cognitive load, especially for trainees, as it relies on image interpretation, anatomical and surgical knowledge, experience, and spatial sense. The purpose of this study is to determine if 3D reconstruction of preoperative CT/MR images will assist resident-level trainees in making appropriate operative plans for liver resection surgery. DESIGN: Ten preoperative patient CT/MR images were selected. Images were case-matched, 5 to 2D planning and 5 to 3D planning. Images from the 3D group were segmented to create interactive digital models that the resident can manipulate to view the tumor(s) in relation to landmark hepatic structures. Residents were asked to evaluate the images and devise a surgical resection plan for each image. The resident alternated between 2D and 3D planning, in a randomly generated order. The primary outcome was the accuracy of resident's plan compared to expert opinion. Time to devise each surgical plan was the secondary outcome. Residents completed a prestudy and poststudy questionnaire regarding their experience with liver surgery and the 3D planning software. SETTING AND PARTICIPANTS: Senior level surgical residents from the Queen's University General Surgery residency program were recruited to participate. RESULTS: A total of 14 residents participated in the study. The median correct response rate was 2 of 5 (40%; range: 0-4) for the 2D group, and 3 of 5 (60%; range: 1-5) for the 3D group (p < 0.01). The average time to complete each plan was 156 ± 107 seconds for the 2D group, and 84 ± 73 seconds for the 3D group (p < 0.01). A total 13 of 14 residents found the 3D model easier to use than the 2D. Most residents noticed a difference between the 2 modalities and found that the 3D model improved their confidence with the surgical plan proposed. CONCLUSIONS: The results of this study show that 3D reconstruction for liver surgery planning increases accuracy of resident surgical planning and decreases amount of time required. 3D reconstruction would be a useful model for improving trainee understanding of liver anatomy and surgical resection, and would serve as an adjunct to current 2D planning methods. This has the potential to be developed into a module for teaching liver surgery in a competency-based medical curriculum.

Intraperitoneal ketorolac for post-cholecystectomy pain: a double-blind randomized-controlled trial.

PURPOSE: Ketorolac is a parenterally active nonsteroidal anti-inflammatory drug with localized anti-inflammatory properties. We examine the postoperative analgesic efficacy of locally administered intraperitoneal (IP) ketorolac compared with intravenous (IV) ketorolac during laparoscopic cholecystectomy. METHODS: With institutional ethics approval, 120 patients undergoing elective laparoscopic cholecystectomy were randomized to receive intraoperative 1) IP ketorolac 30 mg + intravenous saline (IP group), 2) intraperitoneal saline + IV ketorolac 30 mg (IV group), or 3) intraperitoneal saline + intravenous saline (Control group) under standardized anesthesia. The primary and secondary outcomes were postoperative fentanyl requirements in the postanesthesia care unit and the time to first analgesic request, respectively. Other outcomes examined included abdominal pain (at rest and with coughing), shoulder pain, nausea, vomiting, and any other postoperative complications. RESULTS: On average, patients receiving IP ketorolac required less (mean difference, 29 µg; 95% confidence interval [CI], 2 to 56; P = 0.04) fentanyl than patients in the Control group but a similar (mean difference, 16 µg; 95% CI, 12 to 43; P = 0.27) amount compared to patients in the IV group. There was an increase in the median (interquartile range [IQR]) time to first request in the IP group (43[30-52] min) compared with the Control group (35 [27-49]min; P = 0.04) but no difference between the IP group compared with the IV group (47 [40-75] min; P = 0.22). Shoulder pain and resting pain were reduced with IP and IV ketorolac compared with Control, but there was no difference between the IP and IV groups. No differences were observed in any other outcomes, side effects, or complications attributable to opioids or ketorolac at any time points. CONCLUSION: This study did not demonstrate any advantage for the off-label topical intraperitoneal administration of ketorolac in this surgical population. Intraperitoneal and IV ketorolac showed comparable analgesic efficacy following laparoscopic cholecystectomy.

Effect of PET before liver resection on surgical management for colorectal adenocarcinoma metastases: a randomized clinical trial.

IMPORTANCE: Patients with colorectal cancer with liver metastases undergo hepatic resection with curative intent. Positron emission tomography combined with computed tomography (PET-CT) could help avoid noncurative surgery by identifying patients with occult metastases. OBJECTIVES: To determine the effect of preoperative PET-CT vs no PET-CT (control) on the surgical management of patients with resectable metastases and to investigate the effect of PET-CT on survival and the association between the standardized uptake value (ratio of tissue radioactivity to injected radioactivity adjusted by weight) and survival. DESIGN, SETTING, AND PARTICIPANTS: A randomized trial of patients older than 18 years with colorectal cancer treated by surgery, with resectable metastases based on CT scans of the chest, abdomen, and pelvis within the previous 30 days, and with a clear colonoscopy within the previous 18 months was conducted between 2005 and 2013, involving 21 surgeons at 9 hospitals in Ontario, Canada, with PET-CT scanners at 5 academic institutions. INTERVENTIONS: Patients were randomized using a 2 to 1 ratio to PET-CT or control. MAIN OUTCOMES AND MEASURES: The primary outcome was a change in surgical management defined as canceled hepatic surgery, more extensive hepatic surgery, or additional organ surgery based on the PET-CT. Survival was a secondary outcome. RESULTS: Of the 263 patients who underwent PET-CT, 21 had a change in surgical management (8.0%; 95% CI, 5.0%-11.9%). Specifically, 7 patients (2.7%) did not undergo laparotomy, 4 (1.5%) had more extensive hepatic surgery, 9 (3.4%) had additional organ surgery (8 of whom had hepatic resection), and the abdominal cavity was opened in 1 patient but hepatic surgery was not performed and the cavity was closed. Liver resection was performed in 91% of patients in the PET-CT group and 92% of the control group. After a median follow-up of 36 months, the estimated mortality rate was 11.13 (95% CI, 8.95-13.68) events/1000 person-months for the PET-CT group and 12.71 (95% CI, 9.40-16.80) events/1000 person-months for the control group. Survival did not differ between the 2 groups (hazard ratio, 0.86 [95% CI, 0.60-1.21]; P = .38). The standardized uptake value was associated with survival (hazard ratio, 1.11 [90% CI, 1.07-1.15] per unit increase; P < .001). The C statistic for the model including the standardized uptake value was 0.62 (95% CI, 0.56-0.68) and without it was 0.50 (95% CI, 0.44-0.56). The difference in C statistics is 0.12 (95% CI, 0.04-0.21). The low C statistic suggests that the standard uptake value is not a strong predictor of overall survival. CONCLUSIONS AND RELEVANCE: Among patients with potentially resectable hepatic metastases of colorectal adenocarcinoma, the use of PET-CT compared with CT alone did not result in frequent change in surgical management. These findings raise questions about the value of PET-CT scans in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00265356.

A prospective, randomized assessment of a spatial orientation device in natural orifice transluminal endoscopic surgery.

BACKGROUND: One of the challenges in natural orifice transluminal endoscopic surgery (NOTES) is spatial orientation. The Queen's NOTES group has devised a novel method of orientation by using a magnetic device that passes within an endoscope channel allowing for 3-dimensional imaging of the shape and orientation of the endoscope. OBJECTIVE: To assess the feasibility and utility of a novel orientation device. DESIGN: Randomized, controlled trial. SETTING: Animal research laboratory study on four 25-kg pigs. INTERVENTION: The device was tested by 6 endoscopists and 6 laparoscopic surgeons. Starting at the gastrotomy, the time to identify 4 targets was recorded. Participants were required to identify and touch the gallbladder, the fallopian tube, a clip on the abdominal wall, and the liver edge. Use of the orientation device was randomized for each session. MAIN OUTCOME MEASUREMENTS: Time to identify targets with and without the device. Secondary analysis assessed differences between medical specialties and level of training. RESULTS: The mean time to identify all 4 targets with the device was 75.08 ± 42.68 seconds versus 100.20 ± 60.70 seconds without the device (P <.001). The mean time to identify all 4 targets on the first attempt was 102.29 ± 61.36 seconds versus 72.99 ± 40.19 seconds on the second attempt (P <.001). No differences based on specialty or level of training were identified. LIMITATIONS: Small sample size and simplicity of tasks. CONCLUSION: Regardless of randomization order, both groups were faster with the device. These encouraging results warrant further study using more complex scenarios.

Large-diameter self-expanding metal stents appear to be safe and effective for malignant colonic obstruction with and without concurrent use of chemotherapy.

BACKGROUND: Colonic stents are used chiefly for malignant large-bowel obstruction as a palliative measure or bridge to surgery that facilitates one-step resections. Literature on colorectal stenting demonstrates good safety and efficacy; however, a recent trial has raised concerns regarding the safety of a new large-diameter stent, especially in the setting of concurrent chemotherapy. This study evaluated our experience with colorectal stenting using mainly this stent. METHODS: The study was a retrospective chart review with a minimum 6-month telephone follow-up of patients who underwent colorectal stenting for malignant obstruction at Queen's University between December 2005 and March 2008. The primary outcome was clinical success, defined as full or partial relief of obstructive symptoms or successful bridge to surgery. Clinical failure was defined as persistence or recurrence of obstructive symptoms, death from obstruction, or the need for unplanned surgical intervention. RESULTS: Thirty patients underwent stenting for malignant obstruction during the study period. The technical success rate was 96.7%. Clinical success was 83% at 30 days and 69% at 6 months. The complication rate was 20%, with four early and two late complications. There were no perforations or stent migrations. Thirty-three percent of patients received chemotherapy with a stent in situ; this was not associated with an increased complication rate. Ninety-one percent of patients and families reported satisfaction with the procedure. CONCLUSIONS: Large-diameter stents appear to be safe for malignant colonic obstruction with and without concurrent chemotherapy and they have similar complication rates as older-generation stents with perhaps lower migration potential.

Undifferentiated pancreatic carcinoma with osteoclast-like giant cells: report of a case with osteochondroid differentiation.

We report a case of an undifferentiated pancreatic carcinoma with osteoclast-like giant cells with focal osteochondroid differentiation in a 66-year-old man, who presented with painless jaundice, pruritus, and weight loss. Imaging studies revealed an inhomogeneous mass in the head of the pancreas. A pylorus preserving pancreaticoduodenectomy was performed. The resection specimen revealed a 9.5 x 4.2 x 3.2 cm(3) solid neoplasm in the pancreatic head with direct extension into duodenum and common bile duct. Microscopy showed a cellular neoplasm composed of pleomorphic mononuclear cells (pancytokeratin, and EMA-positive; LCA, and CD68 negative) and osteoclast-like multinucleated giant cells (vimentin, LCA, and CD68-positive; pancytokeratin, and EMA-negative) consistent with OGTP. The tumor contained a focal area of osteochondroid differentiation. Evidence supports that the tumor giant cells are non-neoplastic and of histiocytic origin. Osteochondroid differentiation within undifferentiated carcinoma is unusual; its presence might suggest a sarcoma diagnosis on biopsy material.

Risk of emergency admission while awaiting elective cholecystectomy.

BACKGROUND: There is uncertainty regarding the frequency of adverse events while on a surgical waiting list. We assess the relationship between the duration of wait for cholecystectomy and the risk of emergency admission. METHODS: We analyzed time to emergency admission in a group of 761 patients who underwent cholecystectomy after being seen in clinic for biliary colic and placed on waiting lists at 2 acute care centres in Ontario, from 1997 to 2000. RESULTS: Emergency admissions due to worsening symptoms occurred in 51 patients (6.7%) waiting for elective cholecystectomy. The weekly rate of emergency admission was low during the first 19 weeks on the list, but increased almost by a factor of 3 after 20 weeks (rate ratio 2.7; 95% confidence interval 2.0-3.7). Relative to the first 4 weeks on the list, the rate was 1.6 times higher after 20 weeks, 2 times higher after 28 weeks and 7 times higher after 40 weeks. INTERPRETATION: The probability that a patient on a waiting list will be admitted for emergency cholecystectomy consistently increases with the duration of wait, particularly after 20 weeks.