Dataset Information

Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus minimally invasive esophagectomy for resectable esophageal adenocarcinoma, a randomized controlled trial (ROBOT-2 trial).

ABSTRACT:

Background

For patients with esophageal adenocarcinoma or cancer of the gastroesophageal junction, radical esophagectomy with 2-field lymphadenectomy is the cornerstone of the multimodality treatment with curative intent. Both conventional minimally invasive esophagectomy (MIE) and robot assisted minimally invasive esophagectomy (RAMIE) were shown to be superior compared to open transthoracic esophagectomy considering postoperative complications. However, no randomized comparison exists between MIE and RAMIE in the Western World for patients with esophageal adenocarcinoma.

Methods

This is an investigator-initiated and investigator-driven multicenter randomized controlled parallel-group superiority trial. All adult patients (age ≥ 18 and ≤ 90 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 218) with resectable esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction are randomized to either RAMIE (n = 109) or MIE (n = 109). The primary outcome of this study is the total number of resected abdominal and mediastinal lymph nodes specified per lymph node station.

Conclusion

This is the first randomized controlled trial designed to compare RAMIE to MIE as surgical treatment for resectable esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction in the Western World. The hypothesis of the proposed study is that RAMIE will result in a higher abdominal and mediastinal lymph node yield specified per station compared to conventional MIE. Short-term results and the primary endpoint (total number of resected abdominal and mediastinal lymph nodes per lymph node station) will be analyzed and published after discharge of the last randomized patient within this trial.

Trial registration

ClinicalTrials.gov Identifier: NCT04306458 . Registered 13th March 2020, https://clinicaltrials.gov/ct2/show/NCT04306458; Date of first enrolment 18.01.2021; Target sample size 218; Recruitment status: Recruiting; Protocol version 2; Issue date 10.03.2020; Rev. 02.02.2021; Authors ET, PCvdS, PPG.

SUBMITTER: Tagkalos E

PROVIDER: S-EPMC8474742 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%).Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer.This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ? 18 and ? 80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE (n = 56) or open three-stage transthoracic esophageal resection (n = 56). The primary outcome of this study is the percentage of overall complications (grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications.This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient.Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790.

Project description:Patients with upper third esophageal cancer or esophageal cancer with upper mediastinal paratracheal lymph node metastases are often precluded from surgery because of technical difficulties. With the aid of robotic surgery, an excellent overview and reach of the thoracic inlet can be accomplished. In this way, patients with upper mediastinal esophageal cancer are eligible for esophageal resection with curative intent. The aim of this study was to review the results of a consecutive series of patients who underwent robot-assisted minimally invasive esophagectomy (RAMIE) for tumors of the upper 1/3 of the esophagus or positive lymph nodes in the upper mediastinum.Between 2007-2016, 31 patients who underwent RAMIE in the UMC Utrecht for proximal esophageal cancer or proximal thoracic lymphadenopathy were identified from a prospective surgical database. Perioperative characteristics and oncologic outcomes were collected.The majority of patients had a squamous cell carcinoma. Clinical tumor stage was cT3 or higher in 25 (81%) of patients. Clinically positive lymph nodes (cN1-3) were observed in 29 (94%) patients. Neoadjuvant treatment was administered in 27 (87%) patients. Median duration of the surgical procedure was 435 min (range 299-874 min). Pulmonary complications were most frequent and occurred in 13 (42%) patients. Median intensive care (ICU stay) was 1 day (range 1-65 days) and median overall postoperative hospital stay was 15 days (range 10-118 days). In hospital mortality was 10%. Causes of mortality were tracheo-neo-esophageal fistula, sepsis after abdominal wall drainage due to leakage of the jejunal fistula resulting in respiratory and kidney failure, after which refraining further treatment resulting in death, and irreversible ARDS in a patient with COPD Gold III needing extracorporeal life support. Radical resection was achieved in 30 (97%) of the patients. Median number of retrieved lymph nodes was 22 (range 9-57). Median time of follow up was 18 months (range 3-81 months). Median disease-free survival was 13 months (range 0-81 months) and median overall survival was 16 months (range 0-81 months). Tumor recurrence occurred in 15 patients (48%) and was locoregional only in 3 patients, systemic only in 5 patients and combined locoregional and systemic in 7 patients.Robot assisted thoraco-laparoscopic esophagectomy with curative intent in patients with upper mediastinal esophageal cancer is feasible, but associated with increased in hospital mortality. Short-term oncologic results are encouraging.

Project description:BACKGROUND:Currently, there are three main surgical approaches for resectable esophageal cancer: open transthoracic esophagectomy (OTE), conventional minimally invasive esophagectomy (MIE) and robot-assisted esophagectomy (RAE). Previous studies had demonstrated the better short-term outcomes in MIE or RAE when compared to OTE, respectively. However, to date, no prospective study was designed to compare these two minimally invasive approaches (MIE and RAE). The primary objective of this study is to compare the outcomes on survival, safety and efficacy, quality of life between RAE and MIE in the treatment for resectable esophageal squamous cell carcinoma (ESCC). METHODS:This study is designed as a multicenter, prospective, randomized, non-inferiority phase III clinical trial, investigating the safety and efficacy of RAE compared with MIE in the treatment of resectable ESCC. Eligible patients are randomly assigned to either RAE (n?=?180) or MIE (n?=?180) group. The follow-up visits will be scheduled at 3, 6, 9, and 12?months in the first two years, and then every 6?months until the end of the study. During the follow-up period, clinical data and quality of life questionnaires will be examined. The primary endpoint is the 5-year overall survival (OS). The secondary endpoints are 3-year OS, 5-year disease-free survival (DFS), short-term outcomes as well as quality of life. DISCUSSION:This is the first prospectively randomized controlled trial designed to compare RAE with MIE as surgical treatment for resectable ESCC. According to our hypothesis, RAE will result in at least similar oncologic outcomes and long-term quality of life, but with a shorter operation time, lower percentage of perioperative complications, lower blood loss, and shorter hospital stay when compared with MIE. This study started in July 2017. Follow-up will terminate after 5?years from the time when the last patient was enrolled. TRIAL REGISTRATION:ClinicalTrial.gov: NCT03094351 (March 29, 2017). The trial was prospectively registered.

Project description:BackgroundAdequate pain control after open esophagectomy is associated with reduced complications, earlier recovery and higher patient satisfaction. While further developing surgical procedures like robot-assisted minimally invasive esophagectomy (RAMIE) it is relevant to adapt postoperative pain management. The primary question of this observational survey was whether one of the two standard treatments, thoracic epidural analgesia (TEA) or intravenous patient-controlled analgesia (PCA), is superior for pain control after RAMIE as the optimal pain management for these patients still remains unclear. Use of additional analgesics, changes in forced expiratory volume in 1 s (FEV1), postoperative complications and duration of intensive care and hospital stay were also analyzed.MethodsThis prospective observational pilot study analyzed 50 patients undergoing RAMIE (postoperative PCA with piritramide or TEA using bupivacaine; each n = 25). Patient reported pain using the numeric rating scale score and differences in FEV1 using a micro spirometer were measured at postoperative day 1, 3 and 7. Additional data of secondary endpoints were collected from patient charts.ResultsKey demographics, comorbidity, clinical and operative variables were equivalently distributed. Patients receiving TEA had lower pain scores and a longer-lasting pain relief. Moreover, TEA was an independent predictive variable for reduced length of hospital stay (HR -3.560 (95% CI: -6.838 to -0.282), p = 0.034).ConclusionsAlthough RAMIE leads to reduced surgical trauma, a less invasive pain therapy with PCA appears to be inferior compared to TEA in case of sufficient postoperative analgesia and length of hospital stay. According to the results of this observational pilot study analgesia with TEA provided better and longer-lasting pain relief compared to PCA. Further randomized controlled trials should be conducted to evaluate the optimal postoperative analgesic treatment for RAMIE.

Project description:ObjectiveTo develop a deep learning algorithm for anatomy recognition in thoracoscopic video frames from robot-assisted minimally invasive esophagectomy (RAMIE) procedures using deep learning.BackgroundRAMIE is a complex operation with substantial perioperative morbidity and a considerable learning curve. Automatic anatomy recognition may improve surgical orientation and recognition of anatomical structures and might contribute to reducing morbidity or learning curves. Studies regarding anatomy recognition in complex surgical procedures are currently lacking.MethodsEighty-three videos of consecutive RAMIE procedures between 2018 and 2022 were retrospectively collected at University Medical Center Utrecht. A surgical PhD candidate and an expert surgeon annotated the azygos vein and vena cava, aorta, and right lung on 1050 thoracoscopic frames. 850 frames were used for training of a convolutional neural network (CNN) to segment the anatomical structures. The remaining 200 frames of the dataset were used for testing the CNN. The Dice and 95% Hausdorff distance (95HD) were calculated to assess algorithm accuracy.ResultsThe median Dice of the algorithm was 0.79 (IQR = 0.20) for segmentation of the azygos vein and/or vena cava. A median Dice coefficient of 0.74 (IQR = 0.86) and 0.89 (IQR = 0.30) were obtained for segmentation of the aorta and lung, respectively. Inference time was 0.026 s (39 Hz). The prediction of the deep learning algorithm was compared with the expert surgeon annotations, showing an accuracy measured in median Dice of 0.70 (IQR = 0.19), 0.88 (IQR = 0.07), and 0.90 (0.10) for the vena cava and/or azygos vein, aorta, and lung, respectively.ConclusionThis study shows that deep learning-based semantic segmentation has potential for anatomy recognition in RAMIE video frames. The inference time of the algorithm facilitated real-time anatomy recognition. Clinical applicability should be assessed in prospective clinical studies.

Project description:BackgroundWith Surgomics, we aim for personalized prediction of the patient's surgical outcome using machine-learning (ML) on multimodal intraoperative data to extract surgomic features as surgical process characteristics. As high-quality annotations by medical experts are crucial, but still a bottleneck, we prospectively investigate active learning (AL) to reduce annotation effort and present automatic recognition of surgomic features.MethodsTo establish a process for development of surgomic features, ten video-based features related to bleeding, as highly relevant intraoperative complication, were chosen. They comprise the amount of blood and smoke in the surgical field, six instruments, and two anatomic structures. Annotation of selected frames from robot-assisted minimally invasive esophagectomies was performed by at least three independent medical experts. To test whether AL reduces annotation effort, we performed a prospective annotation study comparing AL with equidistant sampling (EQS) for frame selection. Multiple Bayesian ResNet18 architectures were trained on a multicentric dataset, consisting of 22 videos from two centers.ResultsIn total, 14,004 frames were tag annotated. A mean F1-score of 0.75 ± 0.16 was achieved for all features. The highest F1-score was achieved for the instruments (mean 0.80 ± 0.17). This result is also reflected in the inter-rater-agreement (1-rater-kappa > 0.82). Compared to EQS, AL showed better recognition results for the instruments with a significant difference in the McNemar test comparing correctness of predictions. Moreover, in contrast to EQS, AL selected more frames of the four less common instruments (1512 vs. 607 frames) and achieved higher F1-scores for common instruments while requiring less training frames.ConclusionWe presented ten surgomic features relevant for bleeding events in esophageal surgery automatically extracted from surgical video using ML. AL showed the potential to reduce annotation effort while keeping ML performance high for selected features. The source code and the trained models are published open source.