Feasibility and safety of intraoperative bile duct clearance by antegrade transcystic balloon sphincteroplasty: A prospective observational pilot study.

BACKGROUND: Concomitant cholecystolithiasis and choledocholithiasis are common. Standard treatments are endoscopic retrograde cholangiography (ERC) followed by cholecystectomy or laparoendoscopic rendezvous. Endoscopic retrograde cholangiography has drawbacks, such as post-ERC pancreatitis or bleeding, and potentially more than one intervention is required to address common bile duct (CBD) stones. Safety and feasibility of an intraoperative antegrade transcystic single-stage approach during cholecystectomy with balloon sphincteroplasty and pushing of stones to the duodenum has not been evaluated prospectively. The aim of this pilot study was to evaluate this procedure regarding safety, feasibility, and stone clearance rate. METHODS: Prospective single-center intervention study (SUPER Reporting-Guideline). Main inclusion criterion was confirmed choledocholithiasis (stones ≤6 mm) at intraoperative cholangiography. Success of the procedure was defined as CBD stone clearance at intraoperative control cholangiography, absence of symptoms and no elevated cholestasis parameters at 6 weeks follow-up. Simon's two-stage design was used to determine sample size. RESULTS: From January 2021 to April 2022, a total of 57 patients fulfilled the final inclusion criteria and were included. Mild pancreatitis or cholangitis were present upon admission in 15 (26%) and 15 (26%) patients, respectively. Median number of CBD-stones was 1 (1-6). Median stone diameter was 4 mm (0.1-6 mm). Common bile duct stone clearance was achieved in 54 patients (94%). The main reason for failed CBD clearance was the inability to push the guidewire along the biliary stone into the duodenum. Median intervention time was 28 minutes (14-129 minutes). While there was no postoperative pancreatitis, two patients (3.5%) had asymptomatic hyperlipasemia 4 hours postoperatively. CONCLUSION: Intraoperative CBD stone clearance by antegrade balloon sphincteroplasty appears to be safe and highly feasible. Its overall superiority to the current standards warrants evaluation by a randomized controlled trial. LEVEL OF EVIDENCE: Therapeutic/Care Management, Level V.

Effects of structured intraoperative briefings on patient outcomes: multicentre before-and-after study.

BACKGROUND: Operations require collaboration between surgeons, anaesthetia professionals, and nurses. The aim of this study was to determine whether intraoperative briefings influence patient outcomes. METHODS: In a before-and-after controlled trial (9 months baseline; 9 months intervention), intraoperative briefings were introduced in four general surgery centres between 2015 and 2018. During the operation, the responsible surgeon (most senior surgeon present) briefed the surgical team using the StOP? protocol about: progress of the operation (Status), next steps (Objectives), possible problems (Problems), and encouraged asking questions (?). Differences between baseline and intervention were analysed regarding surgical-site infections (primary outcome), mortality, unplanned reoperations, and duration of hospital stay (secondary outcomes), using inverse probability of treatment (IPT) weighting based on propensity scores. RESULTS: In total, 8256 patients underwent surgery in the study. Endpoint data were available for 7745 patients (93.8 per cent). IPT-weighted and adjusted intention-to-treat analyses showed no differences in surgical-site infections between baseline and intervention (9.8 versus 9.6 per cent respectively; adjusted difference (AD) -0.15 (95 per cent c.i. -1.45 to 1.14) per cent; odds ratio (OR) 0.92, 95 per cent c.i. 0.83 to 1.15; P = 0.797), but there were reductions in mortality (1.6 versus 1.1 per cent; AD -0.54 (-1.04 to -0.03) per cent; OR 0.60, 0.39 to 0.92; P = 0.018), unplanned reoperations (6.4 versus 4.8 per cent; AD -1.66 (-2.69 to -0.62) per cent; OR 0.72, 0.59 to 0.89; P = 0.002), and fewer prolonged hospital stays (21.6 versus 19.8 per cent; AD -1.82 (-3.48 to -0.15) per cent; OR 0.87, 0.77 to 0.98; P = 0.024). CONCLUSION: Short intraoperative briefings improve patient outcomes and should be performed routinely.

Outcomes of surgery depend on patient characteristics and surgeon expertise, but also on teamwork, notably communication. The present study introduces the StOP? protocol, in which the surgeon informs the team about the current status (St), objectives regarding next steps (O), and potential problems (P), and encourages the team to ask questions and raise concerns (?). The results suggest an effect of the StOP? intervention on patient mortality, risk of unplanned reoperation, and duration of hospital stay, but not on surgical-site infections. The study is promising regarding the effect of structured intraoperative communication on important patient outcomes. The study compared patient outcomes at baseline and after implementation of the StOP? protocol, which enhances exchange of structured information within the interdisciplinary surgical team during the course of the operation. The intention-to-treat analyses in this multicentre before-and-after study of 8256 patients undergoing general surgery showed no differences between baseline and intervention for surgical-site infections, but revealed reduced mortality and unplanned reoperations, and fewer prolonged hospital stays during the intervention period.

Ultrasound Based Planning and Navigation for Non-Anatomical Liver Resections - An Ex-Vivo Study.

Goal: Non-anatomical resections of liver tumors can be very challenging as the surgeon cannot use anatomical landmarks on the liver surface or in the ultrasound image for guidance. This makes it difficult to achieve negative resection margins (R0) and still preserve as much healthy liver tissue as possible. Even though image-guided surgery systems have been introduced to overcome this challenge, they are still rarely used due to their inaccuracy, time-effort and complexity in usage and setup. Methods: We have developed a novel approach, which allows us to create an intra-operative resection plan using navigated ultrasound. First, the surface is scanned using a navigated ultrasound, followed by tumor segmentation on a midsection ultrasound image. Based on this information, the navigation system calculates an optimal resection strategy and displays it along with the tracked surgical instruments. In this study, this approach was evaluated by three experienced hepatobiliary surgeons on ex-vivo porcine models. Results: Using this technique, an R0 resection could be achieved in 22 out of 23 (95.7% R0 resection rate) cases with a median resection margin of 5.9 mm (IQR 3.5-7.7 mm). The resection margin between operators 1, 2 and 3 was 7.8 mm, 4.15 mm and 5.1 mm respectively (p = 0.054). Conclusions: This approach could represent a useful tool for intra-operative guidance in non-anatomical resection alongside conventional ultrasound guidance. However, instructions and training are essential especially if the operator has not used an image-guidance system before.

Efficiency, Accuracy and Clinical Applicability of a New Image-Guided Surgery System in 3D Laparoscopic Liver Surgery.

BACKGROUND: To investigate efficiency, accuracy and clinical benefit of a new augmented reality system for 3D laparoscopic liver surgery. METHODS: All patients who received laparoscopic liver resection by a new image-guided surgery system with augmented 3D-imaging in a university hospital were included for analysis. Digitally processed preoperative cross-sectional imaging was merged with the laparoscopic image. Intraoperative efficiency of the procedure was measured as time needed to achieve sufficient registration accuracy. Technical accuracy was reported as fiducial registration error (FRE). Clinical benefit was assessed trough a questionnaire, reporting measures in a 5-point Likert scale format ranging from 1 (high) to 5 (low). RESULTS: From January to March 2018, ten laparoscopic liver resections of a total of 18 lesions were performed using the novel augmented reality system. Median time for registration was 8:50 min (range 1:31-23:56). The mean FRE was reduced from 14.0 mm (SD 5.0) in the first registration attempt to 9.2 mm (SD 2.8) in the last attempt. The questionnaire revealed the ease of use of the system (1.2, SD 0.4) and the benefit for resection of vanishing lesions (1.0, SD 0.0) as convincing positive aspects, whereas image registration accuracy for resection guidance was consistently judged as too inaccurate. CONCLUSIONS: Augmented reality in 3D laparoscopic liver surgery with landmark-based registration technique is feasible with only little impact on the intraoperative workflow. The benefit for detecting particularly vanishing lesions is high. For an additional benefit during the resection process, registration accuracy has to be improved and non-rigid registration algorithms will be required to address intraoperative anatomical deformation.

Postoperative morbidity of complete mesocolic excision and central vascular ligation in right colectomy: a retrospective comparative cohort study.

BACKGROUND: To investigate morbidity and mortality following complete mesocolic excision (CME) and central vascular ligation (CVL) in patients undergoing right colectomy. METHODS: Data from consecutive patients undergoing elective right colectomy at a university-affiliated referral centre were retrospectively analysed. Patients who underwent conventional right-sided colonic cancer surgery (January 2001-April 2009, n = 84) were compared to patients who underwent CME/CVL (May 2009-January 2015, n = 71). The primary end point was anastomotic leak. Secondary end points were delayed gastric emptying, severe respiratory failure, mortality and length of hospital stay. RESULTS: No significant difference was found in the rate of anastomotic leak (1.2% in the conventional versus 5.6% in the CME/CVL group, p = 0.108). Patients in the CME/CVL group had a higher 90-day mortality rate (7.0% versus 0.0%, p = 0.019). Four out of five deceased patients suffered from aspiration with consecutive respiratory failure. There was a tendency towards delayed gastric emptying in the CME/CVL group (12.7% versus 7.1%, p = 0.246). Clavien-Dindo complication grades ≥ 2 were similar in both groups with 16 (19%) in the conventional and 15 (21.1%) in the CME/CVL group (p = 0.747). CME/CVL patients had a shorter mean length of stay with 11 versus 14 days (p <  0.001). CONCLUSIONS: Complete mesocolic excision with central vascular ligation in right colectomy seems to have a higher aspiration rate leading to severe respiratory failure and to higher mortality compared to conventional resection methods. Patient selection for this procedure may therefore be crucial.

Design and implementation of an electromagnetic ultrasound-based navigation technique for laparoscopic ablation of liver tumors.

BACKGROUND: Efficient laparoscopic ablation of liver tumors relies on precise tumor visualization and accurate positioning of ablation probes. This study evaluates positional accuracy and procedural efficiency of a dynamic navigation technique based on electromagnetic-tracked laparoscopic ultrasound (ELUS) for laparoscopic ablation of liver tumors. METHODS: The proposed navigation approach combines intraoperative 2D ELUS-based planning for navigated positioning of ablation probes, with immediate 3D ELUS-based validation of intrahepatic probe position. The environmental influence on electromagnetic-tracking stability was evaluated in the operation room. Accuracy of navigated ablation probe positioning assessed as the target-positioning error (TPE), and procedural efficiency defined as time efforts for target definition/navigated targeting and number of probe repositionings, were evaluated in a laparoscopic model and compared with conventional laparoscopic ultrasound (LUS) guidance. RESULTS: The operation-room environment showed interferences < 1 mm on the EM-tracking system. A total of 60 targeting attempts were conducted by three surgeons, with ten targeting attempts using ELUS and ten using conventional LUS each. Median TPE and time for targeting using ELUS and LUS were 4.2 mm (IQR 2.9-5.3 mm) versus 6 mm (IQR 4.7-7.5 mm), and 39 s (IQR 24-47 s) versus 76 s (IQR 47-121 s), respectively (p < 0.01 each). With ELUS, median time for target definition was 48.5 s, with 0 ablation probe repositionings compared to 17 when using LUS. The navigation technique was rated with a mean score of 85.5 on a Standard Usability Scale. CONCLUSIONS: The proposed ELUS-based navigation approach allows for accurate and efficient targeting of liver tumors in a laparoscopic model. Focusing on a dynamic and tumor-targeted navigation technique relying on intraoperative imaging, this avoids potential inaccuracies due to organ deformation and yields a user-friendly technique for efficient laparoscopic ablation of liver tumors.