scholarly journals Implementation of Minimally Invasive Esophagectomy From a Randomized Controlled Trial Setting to National Practice

2020 ◽  
Vol 38 (19) ◽  
pp. 2130-2139 ◽  
Author(s):  
Sheraz R. Markar ◽  
Melody Ni ◽  
Suzanne S. Gisbertz ◽  
Leonie van der Werf ◽  
Jennifer Straatman ◽  
...  

PURPOSE The aim of this study was to examine the external validity of the randomized TIME trial, when minimally invasive esophagectomy (MIE) was implemented nationally in the Netherlands, using data from the Dutch Upper GI Cancer Audit (DUCA) for transthoracic esophagectomy. METHODS Original patient data from the TIME trial were extracted along with data from the DUCA dataset (2011-2017). Multivariate analysis, with adjustment for patient factors, tumor factors, and year of surgery, was performed for the effect of MIE versus open esophagectomy on clinical outcomes. RESULTS One hundred fifteen patients from the TIME trial (59 MIE v 56 open) and 4,605 patients from the DUCA dataset (2,652 MIE v 1,953 open) were included. In the TIME trial, univariate analysis showed that MIE reduced pulmonary complications and length of hospital stay. On the contrary, in the DUCA dataset, MIE was associated with increased total and pulmonary complications and reoperations; however, benefits included increased proportion of R0 margin and lymph nodes harvested, and reduced 30-day mortality. Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61). In the DUCA dataset, MIE was associated with increased total complications (OR, 1.36; 95% CI, 1.19 to 1.57), pulmonary complications (OR, 1.50; 95% CI, 1.29 to 1.74), reoperations (OR, 1.74; 95% CI, 1.42 to 2.14), and length of hospital stay. Multivariate analysis of the combined and MIE datasets showed that inclusion in the TIME trial was associated with a reduction in reoperations, Clavien-Dindo grade > 1 complications, and length of hospital stay. CONCLUSION When adopted nationally outside the TIME trial, MIE was associated with an increase in total and pulmonary complications and reoperation rate. This may reflect nonexpert surgeons outside of high-volume centers performing this minimally invasive technique in a nonstandardized fashion outside of a controlled environment.

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
R Markar Sheraz ◽  
Ni Melody ◽  
Gisbertz Suzanne ◽  
Straatman Jennifer ◽  
van der Peet Donald ◽  
...  

Abstract Aims The TIME trial showed reduced pulmonary complications from minimally invasive esophagectomy (MIE) over an open approach, and led to widespread adoption of MIE in the Netherlands. The aim of this study was to compare clinical outcomes from minimally invasive esophagectomy in the DUCA (national dataset) and the TIME trial (RCT) for transthoracic esophagectomy1. Methods Original patient data from the TIME trial1 was extracted along-with data from the Dutch National Cancer Audit (DUCA) (2011-2017). Initially univariate analysis was used to compare patient and tumor demographics and clinical and pathological outcomes from patients receiving MIE in the TIME trial and in the DUCA-dataset. Secondly multivariate analysis, with adjustment patient and tumor factors, was performed for the effect of MIE vs. Open esophagectomy on clinical outcomes in both datasets. Thirdly the datasets were combined and multivariate analysis, was performed for the effect of patient inclusion in TIME trial or DUCA-dataset. Results 115 patients from TIME (59 MIE vs. 56 open) and 4605 patients from the DUCA-dataset (2652 MIE vs. 1953 open) were included. Univariate analysis showed, in TIME trial, MIE reduced postoperative complications and length of hospital stay. However in the DUCA-dataset, MIE increased postoperative complications, re-intervention rate and length of hospital stay, however pathological benefits included increased proportion of R0 margin and lymph nodes harvested. Multivariate analysis confirmed the TIME data showed MIE reduced postoperative complications (OR=0.38, 95%CI 0.16–0.90). In the DUCA-dataset, MIE was associated with increased postoperative complications (OR=1.37, 95%CI 1.20–1.55), re-intervention (OR=1.84, 95%CI 1.57–2.14), and length of hospital stay (Coeff=1.57, 95%CI 0.06–3.08). Pathological benefits to MIE in the DUCA-dataset included a reduction in proportion of R1 margin, and increased lymph node harvest. Multivariate analysis of the combined dataset, showed inclusion in the TIME trial was associated with a reduction in postoperative complications (OR=0.23, 95%CI 0.15–0.36) and reoperation rate (OR=0.34, 95%CI 0.17–0.66). Conclusions MIE when adopted nationally outside the TIME-trial, was associated with an increase in postoperative complications and reoperation rate, which may reflect surgeons on a national level going through their proficiency-gain curve in the technique and outside of expert MIE centers.


2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 112-112
Author(s):  
Jeroen Hol ◽  
Joos Heisterkamp ◽  
Barbara Langenhoff

Abstract Background Elderly patients undergoing gastrointestinal surgery are at higher risk for postoperative complications and mortality. Currently available literature on elderly patients undergoing an esophagectomy is inconclusive and dates back from the time before minimally invasive techniques were implemented. Methods Length of hospital stay, 90-day morbidity and mortality were analyzed from patients undergoing minimally invasive esophagectomy (MIE) between 2014 and 2017 in a single center. Data from patients aged 76 years or older was compared to the cohort of patients aged 71 to 75 years old. Results From a consecutive series of in total 187 patients two cohorts were retrieved: 19 patients 76 years or older (group 1) were compared to 41 patients 71 to 75 years old (group 2). Median age was 77 years (76–83) in group 1 and 72 years (71–75) in group 2 (P < 0.05). There were no significant differences in sex, Charlson comorbidity score, number of patients undergoing neoadjuvant chemoradiaton, histological tumor type, tumor stage, number of lymph nodes harvested and type of anastomosis. There were no significant differences in length of hospital stay, 90-day morbidity and mortality. The percentage of anastomotic leakage was 21.2% in group 1 and 14.6% in group 2. Mortality was 10.5% and 4.9% respectively. Conclusion No difference was seen in morbidity and mortality after MIE comparing the eldest old to younger old patients. Therefore, patient selection should not be based on calendar age alone. Disclosure All authors have declared no conflicts of interest.


2021 ◽  
Vol 10 (04) ◽  
pp. 230-235
Author(s):  
Ramachandra Chowdappa ◽  
Anvesh Dharanikota ◽  
Ravi Arjunan ◽  
Syed Althaf ◽  
Chennagiri S. Premalata ◽  
...  

Abstract Background There is a recent rise in the incidence of esophageal carcinoma in India. Surgical resection with or without neoadjuvant chemoradiation is the current treatment modality of choice. Postoperative complications, especially pulmonary complications, affect many patients who undergo open esophagectomy for esophageal cancer. Minimally invasive esophagectomy (MIE) could reduce the pulmonary complications and reduce the postoperative stay. Methodology We performed a retrospective analysis of prospectively collected data of 114 patients with esophageal cancer in the department of surgical oncology at a tertiary cancer center in South India between January 2019 and March 2020. We included patients with resectable cancer of middle or lower third of the esophagus, and gastroesophageal junction tumors (Siewert I). MIE was performed in 27 patients and 78 patients underwent open esophagectomy (OE). The primary outcome measured was postoperative complications of Clavien–Dindo grade II or higher within 30 days. Other outcomes measured include overall mortality within 30 days, intraoperative complications, operative duration and the length of hospital stay. Results A postoperative complication rate of 18.5% was noted in the MIE group, compared with 41% in the OE group (p = 0.034). Pulmonary complications were noted in 7.4% in the MIE group compared to 25.6% in the OE group (p = 0.044). Postoperative mortality rates, intraoperative complications, and other nonpulmonary postoperative complications were almost similar with MIE as with open esophagectomy. Although the median operative time was more in the MIE group (260 minutes vs. 180 minutes; p < 0.0001), the median length of hospital stay was shorter in patients undergoing MIE (9 days vs. 12 days; p = 0.0001). Conclusions We found that MIE resulted in lower incidence of postoperative complications, especially pulmonary complications. Although, MIE was associated with prolonged operative duration, it resulted in shorter hospital stay.


2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 115-116
Author(s):  
Haiqi He ◽  
Junke Fu ◽  
Guangjian Zhang

Abstract Background Surgical resection with radical lymphadenectomy is a pivotal component in the multidisciplinary therapy of esophageal cancer. Minimally invasive esophagectomy was shown to be effective in reducing the morbidity and was adopted increasingly. As a novel minimally invasive technique, robot-assisted esophagectomy remains in the initial stage ofapplication. This study describes the single-institution experience of robotic esophagectomy. Methods Between March 2016 and October 2017, 20 consecutive patients underwent robot assisted esophagectomy at our institute. The thoracic and abdominal mobilization were all performed with the assistance of the robot. We retrospectively collected the operative data and postoperative outcomes. Results The majority of patients were male (80%), and the median age was 62 years. The average operative time was 342 minutes (range 280–440). The average blood loss was 112 ml (range 50–400). No patient experienced conversion to a thoracotomy or laparotomy. R0 resection was achieved in all patients, the mean number of dissected lymph nodes was 19 (range 8–32). No 90-day operative mortality was observed, and postoperative complications were present in 8 of 20 patients (40.0%). Pulmonary complications were the most common event and were observed in 3 patients. Two patients experienced an anastomotic leak. Conclusion Our study demonstrated that robot-assisted esophagectomy is a safe and technically feasible alternative to conventional thoraco-laparoscopic esophagectomy. Disclosure All authors have declared no conflicts of interest.


2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 123-123
Author(s):  
Atila Eroglu ◽  
Yener Aydin ◽  
Ali Ulas ◽  
Coskun Daharli

Abstract Background Development of hiatal hernia after esophageal resection is a known complication. However, due to the spread of minimally invasive esophagectomy, complications of hiatal hernia seems to increase. This study aimed to present our cases with hiatal hernia after Ivor Lewis minimally invasive esophagectomy. Methods After Ivor Lewis minimally invasive esophagectomy, five cases of hiatal hernia were observed. Patients' age, sex, symptoms, diagnosis, herniated organs, surgical method, morbidity and mortality rates and hospital stay were reviewed. Results Three of the patients were male and two were female. The mean age of the patients was 56.2 years (35–71 years). Hiatal hernia was detected after an average of 1.4 years with minimal invasive esophagectomies (5 months, 1 year, 1 year, 18 months and 3 years respectively). Three of the cases were symptomatic and two cases were asymptomatic. Thorax CT was used in all cases, and two cases were additionally imaged with barium esophagography. Herniated organs were: omentum in 5 cases, transverse colon in 4 cases, small bowel in two cases. All cases were laparoscopically approached. Diaphragmatic defects were repaired using nonabsorbable sutures in all cases. No complication and mortality was observed in patients. The mean length of hospital stay was 4.9 days (range, 3 to 10 days). Conclusion Hiatal hernia is more frequently seen in minimally invasive esophagectomies than open esophagectomies. Patients undergoing minimal esophagectomy should be closely monitored for hiatal hernia postoperatively. These cases can also be treated by minimally invasive laparoscopy. Disclosure All authors have declared no conflicts of interest.


2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 112-112
Author(s):  
Yong Yuan

Abstract Background This study was conducted to optimize the surgical procedures for single-port thoracoscopic esophagectomy, and to explore its potential advantages over multi-port minimally invasive esophagectomy. Methods For single-port thoracoscopic esophagectomy, the patient was placed in left lateral-prone position and a 4-cm incision through the 4th-5th intercostal space was taken on the postaxillary line. The 10-mm camera and two or three surgical instruments were used for the VATS esophagectomy and radical mediastinal lymph node dissection. The camera position was different for the upper and lower mediastinal regions. Mobilization of stomach was conducted via multiple-port laparoscopic approach. Cervical end-to-side anastomosis was completed by hand-sewn procedures.A propensity-matched comparison was made between the single-port and four-port thoracoscopic esophagectomy groups. Results From 2014 to 2016, 56 matched patients were analyzed. There was no conversion to open surgery or operative mortality. The use of single-port thoracoscopic esophagectomy increased the length of operation time in comparison with using multiple-port minimally invasive technique (mean, 257 vs. 216 min, P = 0.026). The time taken for thoracic procedure in the single-port group was significant longer that in the multi-port group (mean, 126 vs. 84 min, P < 0.001). There were no significant differences between groups in the number of lymph nodes dissected, blood loss, complications or hospital stay (P > 0.05). In single-port thoracoscopic group, the pain in the abdomen was more severe than that in the chest (P = 0.042). The pain scores for postoperative day 1 and day 7 were significantly lower in the single-port group as compared with multiple-port group (P = 0.038 and P < 0.001), a similar trend could be seen for the pain score on postoperative day 3 (P = 0.058). Conclusion Single-port thoracoscopic esophagectomy contributes to reducing postoperative pain with an acceptable increase of operation time, which does not compromise surgical radicality and has similar short-term postoperative outcomes when compared with multiple-port minimally invasive approach. Disclosure All authors have declared no conflicts of interest.


2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 124-125
Author(s):  
Atila Eroglu ◽  
Coskun Daharli ◽  
Yener Aydin ◽  
Ali Ulas ◽  
Haci Alici

Abstract Background In this study, the efficiency of minimally invasive esophagectomy in esophageal cancer was examined. Methods A total of 100 consecutive patients who were hospitalized due to esophageal cancer and planned minimally invasive esophagectomy were evaluated prospectively between September 2013 and December 2017 in our clinic. Laparoscopic and thoracoscopic esophagectomy was performed in all of the patients included in the study. Inoperable cases were not included in the study. Age and sex of the patients, symptoms, localization of tumor, histopathological type, surgical modality, operation time, length of hospital stay and morbidity and mortality rates were reviewed. Results Thirty-eight (38%) patients were male and 62 (62%) patients were female. The mean age was 55.5 ± 10.8 (32–75 years). The most symptoms were dysphagy (96%) and weight loss (39%). Eighty-one patients (81%) had squamous cell cancer, ten (10%) had adenocarcinoma and nine had another form of esophageal cancer. Neoadjuvant chemoradiotherapy was performed in 36 of the 100 patients. Laparoscopic and thoracoscopic esophagectomy and intrathoracic anastomosis were performed in 94 patients (94%). Laparoscopic and thoracoscopic esophagectomy and neck anastomosis were performed in six patients (6%). The mean duration of operation was 260.1 ± 33.4 minutes (185–335 minutes). The mean intraoperative blood loss was 114.2 ± 191.4 ml (10–800 ml). In 51 (51%) of the patients, complications occurred in perioperative, early postoperative and late postoperative periods. In postoperative complications, anastomotic leak rate was eight patients (8%) and pulmonary complication rate was 21 patients (21%). While mortality was seen in three patients that had diabetes mellitus and hypertension, the 30-day mortality was 2% and the hospital mortality was 3%. The mean hospital stay was 11.2 ± 8.3 days (range 8–44). In our study, the probability of one-year overall survival was 91% and the probability of two years overall survival was 66%. Conclusion Minimally invasive esophagectomy is a safe and preferred method with low mortality, acceptable morbidity, short operative time and short hospital stay and has become a routine approach in the treatment of esophageal cancers. Multicenter studies to be performed in the near future will further assist in defining the benefits of minimally invasive esophagectomy. Disclosure All authors have declared no conflicts of interest.


2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
B F Kingma ◽  
P P Grimminger ◽  
M J van Det ◽  
Y K Chao ◽  
P Chiu ◽  
...  

Abstract Aim The aim of this study was to gain insight in the techniques and outcomes of RAMIE worldwide. Background & Methods Although robot-assisted minimally invasive esophagectomy (RAMIE) is increasingly adopted. The current literature on RAMIE mainly consists of single-center case series with considerable variation in reported techniques and outcomes. To gain an overview of the worldwide practice in RAMIE, an online registry was established by the Upper GI International Robotic Association (UGIRA). The collected data involve patient- and treatment characteristics, as well as postoperative outcomes that include complications as defined by the Esophageal Complications Consensus Group, length of stay, re-admissions (i.e. <30 days after discharge), mortality (i.e. in-hospital or <30 days after surgery), and pathological results. The outcomes were descriptively analyzed for this interim report. Results A total of 434 patients who underwent RAMIE for esophageal cancer between 2016-2019 were included in this interim analysis. The mean age was 63 years (SD ±9.7), the majority was male (n=359, 83%), and nearly all patients had an ASA score ≥2 (n=398, 92%). Adenocarcinoma (n=253, 58%) and squamous cell carcinoma (n=162, 37%) were most prevalent. The usual surgical approach was transthoracic (n=428, 99%) with the patient in semiprone position (n=393, 91%). Gastric conduit reconstruction was performed in all except one patient, who received a colonic interposition. The anastomosis was created by hand-sewing (n=207, 48%), circular stapling (n=142, 32%), or linear stapling (n=85, 20%). The median intraoperative blood loss was 120 milliliters (IQR 70-280) and the median operating time was 392 minutes (IQR 353-455). Postoperative complications occurred in 251 patients (59%) and mainly involved pulmonary complications (n=138, 32%), anastomotic leakage (n=80, 18%), and cardiac complications (n=55, 13%). Mortality occurred in 9 patients (2%) and re-admission because of complications was required in 57 patients (14%). A median of 28 lymph nodes (IQR 21-35) were removed and a radical resection was achieved in 400 patients (92%). Conclusion The presented results are the first to provide an overview of the techniques that are commonly used in RAMIE. By demonstrating results that are in line with recent benchmarking literature, this study demonstrates the safety and feasibility of RAMIE.


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