Mini-invasive Approach Research Articles

Mini-Invasive Thoracic Surgery for Early-Stage Lung Cancer: Which Is the Surgeon's Best Approach for Video-Assisted Thoracic Surgery?

Objectives: The choice of the best Video-Assisted Thoracic Surgery (VATS) surgical approach is still debated. Surgeons are often faced with the choice between innovation and self-confidence. The present study reports the experience of a high-volume single institute, comparing data of uni-portal, bi-portal and tri-portal VATS, to find out the safest and most effective mini-invasive approach, leading surgeon's choice. Methods: Between 2015 and 2022, a total of 210 matched patients underwent VATS lobectomy for early-stage cancer, using uni-portal (fifth intercostal space), bi-portal (seventh space for optic and the fifth), and tri-portal (seventh and the fifth/four) access. Patients were matched for age, BPCO, smoke, comorbidities, lesions (size and staging) to obtain three homogenous groups (A: uni-portal; B: bi-portal; C: tri-portal). The surgeons had comparable expertise. Data were retrospectively collected from institutional database and analyzed. Results: No differences were detected considering time of surgery, length of hospital stay, complications, conversion rate, specific survival, and days of chest tube length of stay. Better results on chest tube removal were described in group A (mean 1.1 days) compared to B (mean 2.6 days) and C (mean 4.7 days); nevertheless, they not statistically significant (p = 0.106). Conclusions: No significant differences among the groups were described, except for the reduction in chest tube permanence in group A. This allows to hypothesize an enhanced recovery after surgery in this group but the different approaches in this series seem to guarantee comparable safety and effectiveness. Considering no superiority of one method above the others, the best suggested approach should be the one for which the surgeon feels more confident.

Short-Term Postoperative Outcomes after Resective Colorectal Surgery in Elderly vs. Nonelderly Patients: A Single Centre Retrospective Analysis

Background/Objectives: Life expectancy for people in their 60s is 24.3 years in high-income countries. Health systems face the burden of disease in the elderly population and must assess the impact of treatments such as major surgery. The aim of this study is to quantify the impact of advanced age on short-term postoperative outcomes after resective colorectal surgery (RCRS). Methods: All patients who underwent RCRS at our institution between July 2022 and November 2023 were entered into a database. Preoperative, perioperative, and early (within 30 days) postoperative data were recorded. Patients were categorized into a young group (under 75 years, YG) and an elderly group (over 75 years, EG). A retrospective comparative analysis of postoperative outcomes was performed between the two groups; postoperative complications were graded according to the Clavien classification. Results: Fifty-three and ninety-five patients were in the EG and YG, respectively. Indications for RCRS was cancer in 83% of EG patients and 61.1% of YG patients (p = 0.006), and the clinical presentation, localization, and rate of neoadjuvant treatment in oncological patients were comparable. Another indication for RCRS was complicated diverticular disease (17% of EG patients and 38.9% of YG patients; p = 0.006). With respect to the baseline characteristics, the ASA and CCI scores were worse in the EG (p = 0.001). No significant differences in the surgical approach, mini-invasive approach, conversion rate, definitive stoma creation, or number of harvested lymph nodes were found between the two groups. Overall, EG reported a higher relative risk (RR) of short-term postoperative complications (1.64, CI: 1.03–2.63), but no significant differences were found in terms of grade ≥3 complications (RR: 0.9, CI: 0.23–3.44). In the EG, a higher risk of ICU admission (RR:2.69, CI: 1.5–4.8) and a one-day longer postoperative hospital stay (6 vs. 5 days) were reported. Conclusions: Advanced age does not seem to contraindicate RCRS, especially in colorectal cancer patients. The impact of elderly age on short-term outcomes seems to be minimal and acceptable.

Uniportal Laser-Assisted Video-Assisted Thoracoscopy (U-LA-VATS) for Lung Metastasectomy: Technical Description, Peri-Operative Results and Pertinent Literature Review.

Pulmonary metastasectomy (PM) is a well-established treatment that is able to contribute to the cure of oligometastatic cancer. Surgery should adopt the most lung-sparing approach possible to preserve pulmonary function (and, consequently, the quality of life) and to spare the lung for potential additional lung resections. In this framework, laser technology has been introduced in recent decades, but only few experiences combining laser technology with VATS approaches have been reported till now. The main focus of this manuscript is to report our institutional experience in performing lung-sparing laser-assisted PM by uniportal VATS (uniportal laser-assisted VATS: U-LA-VATS). The surgical technique and peri-operative results from our series of patients were herein presented and compared with the pertinent literature. Methods: Between March 2021 and November 2023, among 98 patients who underwent PM, a total of 24 patients (18 men (75%); 6 women (25%); mean age 61.4 years; age range 13-83 years) were treated with laser-assisted PM at our institution. Patients who underwent anatomical resection were excluded for the purpose of the analysis. The U-LA-VATS procedure adopted a modified laser-assisted lung resection technique for performing PM via VATS. Dedicated instruments are used, characterized by a long shape and a curved shape, with distal and proximal articulations. A surgical laser system (Thulium + Diodo OUTPUT 30-10 W, Quanta System S.p.a., Solbiate Olona, Italy) was used, and a 550-μm sterile optical fibre conducted through a specific thoracoscopic handpiece was introduced in the lowest part of the incision. Peri-operative results were analysed in all cohort and compared according to the surgical technique. Moreover, these results were compared with those reported in the literature. Comprehensive research of the literature was conducted on PubMed from 2000 to 2024. A review was performed and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Results: In 12 cases (50%), thulium laser-assisted resection was performed using uniportal video-assisted thoracic surgery (VATS), and in the other cases (12, 50%), a (mini)thoracotomy access was adopted. In the thoracotomy group, the mean duration of surgery was 95 ± 57.7 min; meanwhile, it was 73.5 ± 35.5 in the uniportal VATS group. At the univariate analysis, this difference resulted to be statistically significant (p value 0.025). We did not observe intra-operative complications or remarkable malfunction of the laser system. We also did not report major complications after surgery; also the air-leak rate was 8.3% and 0% after thoracotomic and VATS procedures, respectively. Surgical margins were free from disease in all cases. Major and minor post-op complication rates were similar in both groups. The mean hospitalization after surgery was 2.9 ± 0.3 days for the uniportal VATS group and 3.7 ± 0.9 days for the thoracotomy group, this difference being statistically significant at the univariate analysis (p value = 0.015). Conclusions: U-LA-VATS is a safe and effective procedure, able to combine a parenchymal sparing exeresis with a mini-invasive approach. This procedure is associated with a shorter hospital stay compared with PM performed by a thoracotomic approach. Compared with the selected works for the review, our series is the only one describing the use of laser resection combined with a uniportal VATS approach.

Role of ultrasound-guided vacuum-assisted breast biopsy in the management of radiologic-pathologic discordance: a retrospective single-centre study.

To evaluate the efficacy of US-guided vacuum-assisted biopsy (US-VAB) in radiologic-pathologic (rad-path) discordance in women with suspicious breast lesions. Two thousand three hundred and sixty patients with 2385 BI-RADS category 4 and 5 lesions underwent percutaneous US-guided CNB. Thirty-six lesions were classified as discordant benign and underwent second-line US-VAB. A 14-gauge needle was utilized for CNB and 10-gauge for US-VAB. Final pathology was the reference standard for women who underwent surgery, imaging follow-up in other cases. Rates of malignancy for US-VAB and subsequent surgery were evaluated. Lesions with upgrade and no upgrade to second-line VAB were compared in terms of patient's age, lesion type and characteristics, size and BI-RADS category. Positive predictive value (PPV), negative predictive value (NPV) for BI-RADS categories and diagnostic performance for second-line US-VAB were calculated. p value < 0.05 was considered statistically significant (t-test, Mann-Whitney, χ2). US-VAB identified 10 B2, 9 B3 and 17 B5 lesions with upgrade to malignancy of 47.2% (17/36). There were 8 invasive no special type, 7 ductal in situ, 1 invasive lobular carcinoma and 1 angiosarcoma, and their distribution among BI-RADS categories was: 2/2 in BI-RADS 5 (100%), 12/18 in BI-RADS 4C (67%) and 3/16 in BI-RADS 4B lesions (19%) (p = 0.006). Of the remaining 19 lesions, 6 underwent surgery and 2 were upgraded to ductal carcinoma in situ; 13 underwent radiological follow-up and one resulted malignant. False-negative rate for US-VAB was 15.8% (3/19) with final upgrade to malignancy of 55% (20/36). The univariate analysis revealed mass shape (p = 0.008) and BI-RADS categories (p = 0.006) to be associated with upgrade to malignancy. Sensitivity, specificity, PPV, NPV and accuracy for US-VAB were 85, 100, 100, 84 and 92%, respectively. US-VAB identified almost 50% of cancers missed by CNB, avoiding surgical biopsies and validating as an effective mini-invasive approach in rad-path discordance.

To drain or not to drain: A propensity score analysis of abdominal drainage after colorectal surgery for endometriosis

AimTo assess the benefit of prophylactic abdominal drainage (AD) after colorectal surgery for endometriosis. MethodsWe conducted a retrospective study of 215 patients who underwent colorectal surgery for endometriosis using a mini-invasive approach in our center from February 2019 to July 2023. A propensity score matched (PSM) analysis (1:1 ratio) identified two groups of patients with similar characteristics. Postoperative outcomes were then compared. ResultsIn the unmatched cohort, 151 patients (70 %) had AD at the end of surgery and 64 (30 %) did not. Clinical characteristics and surgical procedures were comparable between the groups after PSM. After PSM, AD was associated with a longer hospital stay (p < 0.001) and a greater number of postoperative complications (p = 0.03). There were no differences for readmission, repeat surgery, or severe postoperative complications. ConclusionIn this retrospective cohort of patients undergoing colorectal resection for endometriosis using a mini-invasive approach, prophylactic AD was not found to be beneficial.

Uncommon Restoration on Nonvital Premolar with Porcelain Inlay: A Case Report with Five-year Follow-up

Introduction: In fixed prosthodontics, the old paradigm on endodontically treated teeth leads to more fragilization due to the architectural preparation needed for a full coverage crown. Endodontically treated premolars with class II defects are common in daily practice. When only one proximal surface is affected, direct adhesive restorations are the most used. The use of porcelain inlay is quite uncommon in this situation despite its advantages. Case Presentation: This article illustrates a clinical case of a 31-year-old female with healthy teeth except for the non-vital first maxillary premolar, presenting a class II mesio-occlusal cavity. The occlusion exam revealed functional anterior guidance and canine guidance on both sides during lateral mandibular translation. Based on mini-invasive dentistry principles, the decision was to restore the nonvital bicuspid with a porcelain inlay. Although scientific literature did not report restoration of the premolars with a ceramic inlay in clinical practice, this option was retained. The realization of a porcelain inlay was described step by step. A follow-up up to 5 years was done. Results: The iatrogenic tooth fragilization was avoided by a mini-invasive approach. At the end of this follow-up period, there was no complication or complaint. The patient was satisfied with the final result. Conclusion: Porcelain inlay seems to be a good option to restore the occluso-proximal cavity on nonvital premolars in a context of a favourable occlusion. Porcelain inlay is respectful of the principles of minimally invasive dentistry and allows to achieve the objectives of function, aesthetics and biocompatibility. However, clinical studies should be conducted to investigate the longevity of porcelain inlay on ETPs.

New Insights into Surgical Management of Intrahepatic Cholangiocarcinoma in the Era of “Transplant Oncology”

Intrahepatic cholangiocarcinoma (iCCA) represents the second most frequent type of primary liver neoplasm. The diagnosis and treatment of patients with iCCA involves many challenges. To date, surgical resection with negative margins is the main curative option, achieving an acceptable long-term survival. Despite enabling a considerable improvement in the outcome, iCCA recurrence after surgery is still common. Tumor extension and the histological subtype, as well as vascular and lymph node involvements, are key factors used to define the prognosis. In this narrative review, we aimed to discuss the potential benefits of using different surgical strategies in the field of iCCA, including vascular resection, the mini-invasive approach, liver transplantation, the mechanism used to enable future liver remnant augmentation, and lymph node dissection. We also discussed the new protocols developed in the field of systemic treatment, including immunotherapy and molecular targeted therapy. Recent advancements in the diagnosis, surgical treatment, and understanding of tumor biology have changed the landscape in terms of treatment options. Creating a multidisciplinary tumor board is essential to achieving the best patient outcomes. Further investigational trials are required with the intent of tailoring the treatments and establishing the right patient population who would benefit from the use of new therapeutics algorithms.

Tentacle Mesh for Fixation-Free Spigelian Hernia Repair: Mini-Invasive Approach Granting Broad Defect Overlap.

Compared to other types of abdominal protrusions, Spigelian hernias are not very common. In prosthetic repair of abdominal protrusions, mesh fixation and defect overlap are an open issue, as they are a source of complications. A newly developed tentacle-shaped mesh has been used to ensure a fixation-free repair with a broader defect overlap in the repair of abdominal hernias. This study describes the long-term results of a fixation-free repair of Spigelian hernias carried out with a tentacle mesh. A proprietary mesh composed of a central body with integrated radiating arms was used for repairing Spigelian hernias in 54 patients. The implant was positioned in preperitoneal sublay, and the straps were delivered across the abdominal musculature with a needle passer, and then, after fascia closure, cut short in the subcutaneous layer. The friction of the straps passing through the abdominal wall served to hold the mesh in place, guaranteeing a wide overlap over the defect without fixation. In a long-term follow-up of 6 to 84 months (mean 64 months), a very low rate of complications occurred, but no recurrence was reported. The tentacle strap system of the prosthesis allowed for an easy, fast and safe fixation-free placement granting a wide overlap, avoiding intraoperative complications. Greatly reduced pain and a negligible amount of postoperative complications characterized the postoperative outcome.

Minimally Invasive ALPPS Procedure: A Review of Feasibility and Short-Term Outcomes

Associated liver partition with portal vein ligation for staged hepatectomy (ALPPS) represents a recent strategy to improve resectability of extensive hepatic malignancies. Recent surgical advances, such as the application of technical variants and use of a mini-invasive approach (MI-ALPPS), have been proposed to improve clinical outcomes in terms of morbidity and mortality. A total of 119 MI-ALPPS cases from 6 series were identified and discussed to evaluate the feasibility of the procedure and short-term clinical outcomes. Hepatocellular carcinoma were widely the most common indication for MI-ALPPS. The median estimated blood loss was 260 mL during Stage 1 and 1625 mL in Stage 2. The median length of the procedures was 230 min in Stage 1 and 184 in Stage 2. The median increase ratio of future liver remnant volume was 87.8%. The median major morbidity was 8.14% in Stage 1 and 23.39 in Stage 2. The mortality rate was 0.6%. MI-ALPPS appears to be a feasible and safe procedure, with potentially better short-term outcomes in terms of blood loss, morbidity, and mortality rate if compared with those of open series.

Adrenocortical carcinoma with venous tumor invasion: is there a role for mini-invasive surgery?

This study aims to investigate early oncologic outcomes in patients with adrenocortical carcinoma (ACC) with venous invasion (VI) treated using both open and mini-invasive approaches. We conducted a retrospective analysis of 4 international referral center databases, including all the patients undergoing adrenalectomy for ACC with VI from January 2007 to March 2020. According to CT scan or MRI, the tumor thrombus was classified into four levels: (1) adrenal vein invasion; (2) renal vein invasion; (3) infra-hepatic Inferior vena cava (IVC); and (4) retro-hepatic IVC. In addition, we divided our patients into patients who had undergone open surgery and mini-invasive surgery. We identified 20 patients with a median follow-up of 12 months. The median tumor size was 110mm. ENSAT stage was II in 4 patients, III in 13 patients, and IV in 3 patients. Tumor thrombus extended in the adrenal vein (n=5), renal vein (n=1), infra-hepatic IVC (n=9), or into the retro-hepatic IVC (n=5). Ten patients were treated with a mini-invasive approach. The patient treated with an open approach reported a more aggressive disease. The two groups did not differ in surgical margins, surgical time, blood losses, complications, and length of stay. The prognosis resulted worse in the patient undergoing open. Kaplan-Meier analysis indicated a difference in OS for the patients stratified by ENSAT stage (Log-rank p=0.011); we also reported a difference in DFS for patients stratified for thrombus extension (p=0.004) and ENSAT stage (p<0.001). The DFS of patients with VI from ACC is influenced by the staging and the extension of the venous invasion; the staging influences the OS. The mini-invasive approach seems feasible in selected patients; however, further studies investigating the oncological outcomes are needed. A mini-invasive approach for adrenal tumors with venous invasion is an explorable option in very selected patients.

Colorectal Liver Metastases: A Literature Review of Viable Surgical Options with a Special Focus on Microwave Liver Thermal Ablation and Mini-Invasive Approach.

Colorectal cancer (CRC) is the third most common tumor worldwide and it is characterized in 20-30% of cases by liver involvement, which strongly affects the long-term patient outcome. There are many available therapies for liver colorectal metastases (CRLMs); the current standard of care is represented by liver resection, and when feasible, associated with systemic chemotherapy. Microwave thermal ablation (MWA) is a viable option in unresectable patients or to achieve treatment with a parenchymal spearing approach. A literature review was performed for studies published between January 2000 and July 2022 through a database search using PUBMED/Medline and the Cochrane Collaboration Library with the following MeSH search terms and keywords: microwave, ablation, liver metastases, colorectal neoplasm, and colon liver rectal metastases. The recurrence rate and overall patients' survival were evaluated, showing that laparoscopic MWA is safe and effective to treat CRLMs when resection is not feasible, or a major hepatectomy in fragile patients is necessary. Considering the low morbidity of this procedure, it is a viable option to treat patients with recurrent diseases in the era of effective chemotherapy and multimodal treatments.

Intra-Articular Calcaneal Fractures: Comparison between Mini-Invasive Approach and Kirschner Wires vs. Extensive Approach and Dedicated Plate—A Retrospective Evaluation at Long-Term Follow-Up

Calcaneal fractures (CF) are the most common tarsal fractures, representing up to 75% of foot fractures and 2% of all fractures. The aim of this retrospective study is to analyze fixation with Kirschner wires through a mini-invasive approach and dedicated plate and screws through an extended approach at long-term follow-up. Patients were radiographically and clinically evaluated at final follow-up, by using the validated American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score for the clinical-functional assessment, the Short-Form 12 (SF-12) for the physical and psychological domain assessment, and the Visual Analog Scale (VAS) for pain. In total, 38 patients (42 CF) met the inclusion criteria and were retrospectively evaluated and divided into two groups (Kirschner group and plate group) consisting of 19 patients each. The overall mean follow-up was 59.4 ± 11.8 months. The average values of the post-operative clinical outcomes of the two groups KG and PG were, respectively, 70.7 ± 11.9 and 70.1 ± 10.9 (AOFAS), 45.7 ± 6.8 and 46.5 ± 10.8 (SF-12 PCS), 54.7 ± 9.9 and 50.9 ± 11.8 (SF-12 MCS) at the final follow-up. The present study showed that in the cases analyzed, the two surgical approaches used for the treatment of CF achieved comparable clinical outcomes. The only substantial difference found between the two groups of patients was the re-intervention rate that afflicted them.

Embolization in Pediatric Patients: A Comprehensive Review of Indications, Procedures, and Clinical Outcomes.

Embolization in pediatric patients encompasses a large spectrum of indications, ranging from the elective treatment of congenital diseases of the cardiovascular system to the urgent management of acute hemorrhagic conditions. In particular, the endovascular treatment of central and peripheral vascular malformations and hypervascular tumors represents a wide chapter for both congenital and acquired situations. Thanks to the progressive availability of low-profile endovascular devices and new embolic materials, the mini-invasive approach has gradually overtaken surgery. In this review, the main embolization procedures will be illustrated and discussed, with a focus on clinical indications and expected outcomes. The most recent mini-invasive techniques will be described, with hints on the cutting-edge devices and embolic materials.

Mini-invasive approach vs. traditional open reduction for periprosthetic hip fracture osteosynthesis with the NCB® plate

BackgroundPostoperative hip periprosthetic fracture (PPF) is a frequent complication whose treatment does not achieve optimal results among eldery fragile patients. Locking compression plate (LCP) osteosynthesis is the gold standard treatment for Vancouver B1 and VC fractures and there is a growing consensus in doing the same with B2 fractures in patients with high comorbidity. Following that trend of being as non-aggressive as possible we investigated whether a mini-open (MO) approach would lead to better outcomes in LCP plate osteosynthesis of hip PFFs when compared to the traditional open approach. MethodsWe retrospectively evaluated a cohort of 43 VB1, VB2 or VC hip PPFs treated with non contact bridging (NCB®) plate osteosynthesis by two possible approaches. MO vs traditional open approach. The main objective was to assess whether MO approach decreases operative time, bleeding and local complications. The secondary objective was to demonstrate that this may have a positive effect on patient function. ResultsThe mean age was 79.6 years old and 74.5% patients had an ASA score of III or IV. The surgical time was 148.53 min (SD 33.2) in the open approach versus 107.42 min (SD 25.6) in the MO, which was 31 min shorter (p<0.001). Hemoglobin dropped 0.9 points less, on average (p. 0.005) and 0.82 fewer blood concentrates were required (p. 0.022) with MO approach. There were no differences among complications but there was a trend towards greater independence and better mobility in the MO approach group with a postoperative Barthel of 74.37 (sd. 13.21) compared to the 66.67 points (sd. 13.7) in the traditional approach group. ConclusionMO approach in osteosynthesis of hip PFFs decreases operative time and intraoperative bleeding so it must be considered in fragile patients with high comorbidity.

Arthroscopic-assisted robotic bi-unicompartmental knee arthroplasty: a pilot cadaveric study.

Although bicondylar arthroplasty showed great functional results, it encounters some difficulties to be performed routinely. On the other hand, arthroscopic techniques tend to replace open surgical techniques in sports medicine but strive to be developed in the field of arthroplasty. This study aimed to assess the feasibility of a micro-invasive bi-compartmental knee arthroplasty using both arthroscopic and robotic technologies (A-BiUKA). The study was conducted on complete fresh-frozen and embalmed cadaveric specimens. The main criterion of judgment was the successful positioning of trial implants through a minimal quad-sparing approach. Arthroscopy was used for bone-morphing and burring, supported by an image-free robotic system. Secondary criteria of judgment were axial deviation (measured using the navigation system), operating time, and incision length. Ten A-BiUKA were performed. Implantation was successful in all cases. The mean preoperative frontal deviation was 179.8° ± 3.2 [175: 185], the mean postoperative frontal deviation was 178.5° ± 2.2 [175: 182], without any outliers. The mean correction was 1.7° ± 1.6 [0: 5]. Once the eight first A-UKA were performed, constituting the learning curve, the mean operative time for the remaining twelves surgeries was 90min ± 6. The mean skin incision length was 3.35cm ± 0.13 [3: 4]. Associated arthroscopic and robotic technologies allows to perform Bi-UKA procedure using a quad sparing mini-invasive approach. Clinical prospective studies have to confirm the feasibility and the clinical outcomes of this surgery.

Study of Mechanical Behavior in Epiphyseal Fracture Treated by Reduction and Cement Injection: No Immediate Post-Operative Weight-Bearing but Only Passive and Active Mobilization Should be Advised.

The development of new percutaneous treatment techniques using a balloon for the reduction and cement for the stabilization for tibial plateau fractures (TPF) are promising. The biomechanical changes brought by the cement in the periarticular fracture are unknown. The objective of this study was to provide elements of understanding of the bone behavior in an epiphyseal fracture treated with cementoplasty and to define the modifications brought about by the presence of this cement in the bone from both an architectural and biomechanical point of view. In vitro animal experimentation was conducted. Bones samples were prepared with a cavity created with or without cancellous compaction, aided by balloon expansion following the same protocol as in the treatment of TPF. A uniaxial compression test was performed with various speeds and by using Heaviside Digital Image Correlation to measure mechanical fields. Preliminary finite element models were constructed with various boundary conditions to be compared to our experimental results.The analysis of the images permits us to obtain a representative load vs. time response, the displacement fields, and the strain distribution for crack initiation for each sample. Microcracks and discontinuity began very early at the interface bone/cement. Even when the global behavior was linear, microcracks already happened. There was no strain inside the cement. The finite element model that matched our experiments had no link between the two materials.In this work, the use of a novel correlation process highlighted the biomechanical role of the cement inside the bone. This demonstrated that there is no load transfer between bone and cement. After the surgery, the cement behaves like a rigid body inside the cancellous bone (same as a screw or plate). The cement provides good reduction and primary stabilization (mini-invasive approach and good stress distribution), permitting the patient to undergo rehabilitation with active and passive mobilization, but no weight-bearing should be authorized while the cortical bone is not consolidated or stabilized.

Effect of dosimetric parameters on postoperative respiratory morbidity in locally advanced esophageal cancer treated with preoperative chemoradiotherapy (CRT).

e16075 Background: Postoperative pulmonary complications are common after neoadjuvant CRT of locally advanced esophageal cancers. Using data from the French multicenter randomized phase II PROTECT trial (NCT02359968), we aimed to evaluate the dosimetric parameters which could be associated with the occurrence of postoperative respiratory morbidities in patients (pts) who underwent preoperative CRT. Methods: Key eligibility criteria for the PROTECT trial were stage II or III resectable adenocarcinoma or squamous cell carcinoma of the esophagus located below the carina. Pts received FOLFOX or Carboplatin-Paclitaxel, combined with radiotherapy (RT): total dose of 41.4 Gy, 5 fractions of 1.8 Gy per week, starting at day 1 of chemotherapy. The patient's position and definition of the target volumes and organs at risk were the same as in the CROSS trial (van Hagen, 2012). Pts were treated using 3D conformal RT or IMRT. Surgery occurred 4 to 8 weeks after completion of CRT through a transthoracic or mini-invasive approach with a two field extended lymphadenectomy. Pts recruited in the PROTECT trial up to Sept. 2019 who underwent surgery after CRT were eligible for this ancillary study. The primary endpoint of our translational study was the occurrence of postoperative respiratory morbidity, of any grade (Clavien-Dindo classification for early morbidity &lt; 31 days; NCI-CTCAE v4 for later events), up to 1 year following surgery, considering disease progression or death as competing events. Cause-specific Cox models were used to model the risk of respiratory morbidity, considering the following factors: performance status, BMI, smoking, histological subtype, tumor site, FEV1, RT technique, time interval between CRT and surgery, and dosimetric parameters derived from the Dose-Volume Histogram analysis (mean lung dose, V10Gy, V20Gy and V30Gy, as other parameters strongly correlated to these 4 ones). Results: Among the 98 pts recruited in the PROTECT trial from Feb. 2015 to Sept. 2019, 78 underwent surgery after CRT and were included in our translational study. Median age was 63.5 years (range 33 to 79). Tumor was located at the middle or lower third of the esophagus for 67% of pts. Mean lung dose was 10.2 Gy (sd = 3.2). Mean PTV volume was 566 cc (sd = 272). A total of 33 pts experienced at least one respiratory morbidity (16 pneumonia, 7 pleural effusion, 4 ARDS, 21 miscellaneous events). The cumulative incidence of respiratory morbidity was 42% one month after surgery (95% CI, 32-54), 44% at 3 months (32-54), and 46% at 6 months (35-57). None of the dosimetric parameters and other studied factors appeared associated with postoperative respiratory morbidity. Conclusions: We did not identify dosimetric factors that could predict the risk of postoperative respiratory morbidity after treatment with preoperative CRT with FOLFOX or Carboplatin-Paclitaxel. Clinical trial information: NCT02359968.

Preoperative chemoradiation (CRT) with carboplatin (CBP)/paclitaxel (PCL) (CP) or with 5-fluorouracil (FU)/oxaliplatin (OX) (Fx) for esophageal or junctional cancer: A randomized phase 2 trial.

4015 Background: Preoperative CRT with a FU/platinum regimen has been used for years for esophageal or junctional cancer before the CP regimen became a standard of care following the results of the CROSS study (van Hagen 2012). We aimed at evaluating the complete resection (R0) rate and severe postoperative morbidity rate associated with these 2 neoadjuvant regimens, each being combined with the radiation (RT) regime used in the CROSS trial. Methods: PROTECT is a multicenter, randomized, non-comparative, phase 2 trial (NCT02359968) in patients (pts) with resectable esophageal or Siewert type I-II junctional cancer, stage II (T1-2N1 or T3N0) or stage III (T3N1 or T4anyN) tumors (UICC-7 classification), and ECOG PS ≤2. Following randomization (balanced by ECOG PS 0 vs 1-2, stage II vs III, squamous-cell (SCC) vs adenocarcinoma (ADK), center), pts received CP (AUC2 CBP plus PCL 50mg/m² / week x 5 weeks), or Fx (FU 400 mg/m² bolus Day 1, then FU 1600 mg/m² continuous infusion over 2 days, plus OX 85 mg/m², and Folinic acid 200 mg/m², 2-h infusion, Day 1; 3 cycles every 2 weeks). RT technique was similar in both arms: 3D-conformal as published in the CROSS trial or IMRT (n = 35); total dose of 41.4Gy, 5 fractions of 1.8Gy / week, starting at Day 1 of chemotherapy. Surgery was performed 4 to 8 weeks after completion of CRT through a transthoracic or mini-invasive approach with a two field extended lymphadenectomy. Co-primary endpoints were R0 (failure: R1 or disease progression under CRT), and severe postoperative morbidity rate ≤30 days after surgery (Clavien-Dindo grade ≥ III). Based on a Bryant and Day 2-stage design (p0 = 75% and p1 = 90% for resection; p0 = 45% and p1 = 25% for morbidity; α = 10% and β = 15%), 48 evaluable pts were required by arm. Results: 100/104 pts recruited from 02/2015 to 08/2020, started the study treatment: 50 CP &amp; 50 Fx. Overall, median age = 64 (range, 33-79); 82/100 males; 62 ADK and 38 SCC; 66 esophageal and 34 junctional site; 31 stage II; 68 stage III, 1 Nx. R0 resection was obtained in 46/50 CP pts (92.0%, 95% CI: 80.8-97.8%), and in 42/48 Fx pts (87.5%, 74.8-95.3%); 2 non evaluable pts because of event unrelated to disease progression. Severe postoperative adverse events (AEs) occurred in 34/91 pts who underwent surgery: 21/48 CP (43.8%, 29.5-58.8%) and 13/43 Fx (30.2%, 17.2-46.1%). Severe AEs were respiratory disorders (CP 26%; Fx 26%), esophageal fistula (CP 18%; Fx 6%), infection (CP 5%; Fx 3%), haemorrhage (CP 5%; Fx 0%) and gastric tube necrosis (CP 6%; Fx 3%). 5 pts died from AEs (3 CP, 2 Fx). A TRG1-2 was observed in 29/48 (60.4%, 95% CI: 44.3-74.2%) CP pts, and in 19/43 (44.2%, 29.1-60.1%) Fx pts. Conclusions: When combined to preoperative radiation therapy at 41.4Gy, both regimens (CP and Fx) provided short-term benefit on R0 resection; however, CP is associated with a severe postoperative morbidity rate higher than expected. Clinical trial information: NCT02359968.

EDITORIAL COMMENT

Radical cystectomy (RC) still represents the gold standard therapy for muscle-invasive urinary bladder cancer (MIBC) with 66% recurrence-free survival at 10 years follow-up.1 In the last decade robot-assisted radical cystectomy (RARC) has been increasingly adopted for the treatment of MIBC, resulting not inferior to open surgery regarding surgical complications and oncological outcomes, whereas the supposed benefits of a mini-invasive approach and less surgical trauma basing on reduced hospital stay and improved postoperative QoL could be not demonstrated.

P50 IMPLEMENTATION OF PROTOCOLS FOR “ENHANCED RECOVERY AFTER CARDIAC SURGERY” IN AORTIC VALVE SURGERY

Abstract Objective Although, the use of protocols for “enhanced recovery after surgery” (ERAS) have been associated with improved results in different surgical disciplines, no data are available for EARS in cardiac surgery, thus far. In the late 2016 a mutlidisciplinary ERAS program to treat patients who require AVR was implemented in our institution. The aim of this study was to assess safety and 30 day outcomes in patients receiving ERAS management. Methods To improve multidisciplinary ERAS program, our mini–invasive approach (Fig. 1), that goes beyond a small incision, includes: (i) mini–surgical access (ministernotomy–minithoracotomy), to reduce the traumatic impact, postoperative pain and to increase patient’s satisfaction; (ii) minimal invasive extracorporeal circulation system, to improve end–organ protection and decrease systemic inflammatory response; (iii) ultra fast–track anaesthesia, to decrease the rate of postoperative complications and assure better and earlier recovery (Fig. 2). Results Between September 2016 and December 2021, 600 consecutive patients (mean age 72 years, Euroscore II 1,62%) underwent isolated mini–AVR in our institution. UFT anaesthesia was used in 195 patients (32.5%) and MiECC in 173 (28.8%). All patients received a timely rehabilitation therapy (3–6 hours after surgery) and an early family contact in ICU. At 30 days, the overall mortality and stroke rates were 0,3% (n = 2) and 0,5% (n = 3), respectively. Respiratory insufficiency occurred in 16 pts (2,5%). Median blood loss at 12 hours was 174,5 cc; blood transfusions were reduced to minimum intraoperatively and avoided in 66% of patients. Twenty three patients (3,8%) received definitive pacemaker implantation. The median ICU and in–hospital lengths of stay were 1 and 6 days, respectively. Conclusions Findings from our study confirms that mini–AVR yields excellent clinical outcomes with very low mortality and morbidity rates. The implementation of ERAS protocol in patients undergoing mini–AVR demonstrated to be safe and was associated with promising results. Thus, by reducing surgical injury and promoting faster recovery, ERAS management may further enhance minimally invasive interventions.