Open versus minimally invasive total gastrectomy after neoadjuvant chemotherapy: results of a European randomized trial.

BACKGROUND: Surgical resection with adequate lymphadenectomy is regarded the only curative option for gastric cancer. Regarding minimally invasive techniques, mainly Asian studies showed comparable oncological and short-term postoperative outcomes. The incidence of gastric cancer is lower in the Western population and patients often present with more advanced stages of disease. Therefore, the reproducibility of these Asian results in the Western population remains to be investigated. METHODS: A randomized trial was performed in thirteen hospitals in Europe. Patients with an indication for total gastrectomy who received neoadjuvant chemotherapy were eligible for inclusion and randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG). Primary outcome was oncological safety, measured as the number of resected lymph nodes and radicality. Secondary outcomes were postoperative complications, recovery and 1-year survival. RESULTS: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. The mean number of resected lymph nodes was 43.4 ± 17.3 in OTG and 41.7 ± 16.1 in MITG (p = 0.612). Forty-eight patients in the OTG group had a R0 resection and 44 patients in the MITG group (p = 0.617). One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701). No significant differences were found regarding postoperative complications and recovery. CONCLUSION: These findings provide evidence that MITG after neoadjuvant therapy is not inferior regarding oncological quality of resection in comparison to OTG in Western patients with resectable gastric cancer. In addition, no differences in postoperative complications and recovery were seen.

[Cervical anastomotic leak after esophagectomy: diagnosis and management]. / Fístula cervical postesofagectomía: diagnóstico y tratamiento.

INTRODUCTION: Cervical anastomotic leaks after esophagectomy are still a frequent and severe complication that needs an early diagnosis and an appropriate treatment. The aim of this study was to describe our experience with the management of this complication. PATIENTS AND METHODS: Retrospective study (2003-2011) of a consecutive series of 77 patients with a cervical esophagogastric anastomosis, 18 of them (23.3%) presenting a leak. Fistulae were classified into 4 groups depending on clinical presentation, radiology (esophagogram or CT), surgical findings (in case of re-operation) and, since 2010, endoscopic examination. Type I leaks were an asymptomatic or radiographic leak, type II had local signs limited to the neck, type III was associated with respiratory symptoms due to a pleural or mediastinal collection, and type IV with a systemic disorder secondary to gastric necrosis. RESULTS: Four patients (22.2%) were classified as type I, 8 (44.4%) as type II, 3 (16.6%) as type III, and 3 (16.6%) as type IV. Eight patients were managed conservatively; in 9 a self-expanding stent was used, 5 required a thoracotomy, and one of them (type IV) died. Leaks were related to a higher associated morbidity (61 versus 30%; P=.019) and a longer hospital stay (median of 28.5 vs 14 days; P=.009). CONCLUSIONS: Almost one quarter of cervical esophagogastric anastomoses present some kind of anastomotic leak. Although most of them can be treated conservatively or by endoscopy, they are associated with an increase in morbidity and mortality.

Sleeve gastrectomy as a surgical technique in bariatric surgery: Results of safety and effectiveness.

INTRODUCTION: The aim of this study is to evaluate the safety and effectiveness results of sleeve gastrectomy as a bariatric technique. METHODS: Observational follow-up study of a cohort of patients who underwent sleeve gastrectomy in our center between 2008 and 2017. A total of 223 patients were included: 166 as a primary technique (group 1) and 57 as a hypothetical first stage (group 2). RESULTS: In group 1, the postoperative morbidity is 12.6%, with a fistula rate of 4.2%; 5.4% required reoperation and mortality was 0.6%. In group 2, postoperative morbidity is 14%, with a fistula rate of 5.3%; 10.5% required reoperation and mortality was 5.3%. In group 1, 79.6% and 62.5% of patients at 2 and 5 years respectively managed to achieve a % EBMIL > 50%. In group 2, the second stage was completed only in 8 patients (14.0%). Of the patients who did not complete the second stage, 32.2% and 5.9% achieved a % EEBMIL > 100% at 2 and 5 years. Analyzing those who completed the second stage, the mean EEBMIL% was 90.5% and 93.4% at 2 and 5 years. CONCLUSIONS: Sleeve gastrectomy is a safe technique in patients with BMI < 45 and effective in terms of weight loss in the short-medium term. In patients with BMI > 55, a preoperative optimization aimed at reducing morbidity and mortality is necessary, as well as adequately planning the second stage, without which it is clearly insufficient.

High rate of de novo esophagitis 5 years after sleeve gastrectomy: a prospective multicenter study in Spain.

BACKGROUND: Major concerns years after the sleeve gastrectomy (SG) include weight regain, development of hiatal hernia (HH) and gastroesophageal reflux disease, with esophagitis and Barrett's esophagus (BE). Both problems could be related, and the incidence of asymptomatic patients is troubling. OBJECTIVE: To study the incidence of reflux symptoms, esophagitis, BE, HH, and asymptomatic pathology and their relationship with weight regain in patients 5 years after undergoing SG at different bariatric centers in Spain. SETTING: Public and private hospitals with bariatric surgery units. METHODS: Prospective, multicenter, nonrandomized study involving 13 Spanish hospitals with a cumulative experience of 4,500 patients having undergone the SG procedure and patients who had been subjected to the procedure at least 5 years previously along with preoperative gastroscopy. The clinical history, preoperative gastroscopy, and technical details of the SG were recorded. A specific clinical questionnaire was given that recorded the intake volume, perception of satiety, and gastroesophageal reflux (GER) symptoms. Gastroscopy, pH-metry, and manometry studies were carried out, and the data were analyzed statistically. The study has been authorized by the official Spanish ethics committee CEI/CEIm Hospital Universitario Gran Canaria Dr Negrín (code 2019-216-1). RESULTS: One hundred and five patients who underwent SG and who had with at least 5 years of follow-up were included. All procedures were performed laparoscopically. The mean age of patients was 51.1 years, and 70.5% were women. The mean characteristics of the SG procedure were a 37.2F probe, at 4.6 cm from the pylorus, and a crura closure was performed in 5 cases. There were no major complications (Clavien-Dindo grade >3) or deaths. The average preoperative body mass index was 46.3 kg/m2, the minimum reached was 20.6 kg/m2, whereas the average after 5 years was of 34.5 kg/m2. GER, HH, and esophagitis symptoms went from 17.1%, 28.6%, and 5.7%, respectively, before the SG to 76%, 30.5%, and 31.4%, respectively, 5 years after the procedure. Symptoms persisted over the years in 37.1% of cases and presented de novo in 52.8% of cases. Fifty-three percent of manometries (n = 27, total 51) and 64% of pH-metries (n = 32, total 53; DeMeester average score was 65) were pathologic 5 years after the procedure. Concerning gastroscopies, 5 years after the procedure, HH was found in 33 patients (30.5% of total) and esophagitis in 32 patients (31.4% of total). Eighty patients (76%) had GER symptoms, and 25 patients (24%) were asymptomatic. Only 1 patient (.9%) developed BE. CONCLUSIONS: Our study has confirmed a high rate of both persistent and de novo esophagitis and hiatal hernia, many of which were asymptomatic, 5 years after SG had been performed. Weight regain and a striking increase in gastric capacity are risk factors indicative of esophagitis, even when patients are asymptomatic. We consider a control gastroscopy and the preventive use of proton pump inhibitors necessary in these cases regardless of symptoms. We recommend that a control gastroscopy should be performed in all cases regardless of symptoms 5 years after SG. Further studies are needed to validate these recommendations.

Health related quality of life following open versus minimally invasive total gastrectomy for cancer: Results from a randomized clinical trial.

INTRODUCTION: Minimally invasive techniques show improved short-term and comparable long-term outcomes compared to open techniques in the treatment of gastric cancer and improved survival has been seen with the implementation of multimodality treatment. Therefore, focus of research has shifted towards optimizing treatment regimens and improving quality of life. MATERIALS AND METHODS: A randomized trial was performed in thirteen hospitals in Europe. Patients were randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG) after neoadjuvant chemotherapy. This study investigated patient reported outcome measures (PROMs) on health-related quality of life (HRQoL) following OTG or MITG, using the Euro-Qol-5D (EQ-5D) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires, modules C30 and STO22. Due to multiple testing a p-value < 0.001 was deemed statistically significant. RESULTS: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. A response compliance of 80% was achieved for all PROMs. The EQ5D overall health score one year after surgery was 85 (60-90) in the open group and 68 (50-83.8) in the minimally invasive group (P = 0.049). The median EORTC-QLQ-C30 overall health score one year postoperatively was 83,3 (66,7-83,3) in the open group and 58,3 (35,4-66,7) in the minimally invasive group (P = 0.002). This was not statistically significant. CONCLUSION: No differences were observed between open total gastrectomy and minimally invasive total gastrectomy regarding HRQoL data, collected using the EQ-5D, EORTC QLQ-C30 and EORTC-QLQ-STO22 questionnaires.

Sleeve gastrectomy as a surgical technique in bariatric surgery: Results of safety and effectiveness. / Gastrectomía vertical como técnica quirúrgica en cirugía bariátrica: análisis de resultados de seguridad y efectividad.

INTRODUCTION: The aim of this study is to evaluate the safety and effectiveness results of sleeve gastrectomy as a bariatric technique. METHODS: Observational follow-up study of a cohort of patients who underwent sleeve gastrectomy in our center between 2008 and 2017. A total of 223 patients were included: 166 as a primary technique (group 1) and 57 as a hypothetical first stage (group 2). RESULTS: In group 1, the postoperative morbidity is 12.6%, with a fistula rate of 4.2%; 5.4% required reoperation and mortality was 0.6%. In group 2, postoperative morbidity is 14%, with a fistula rate of 5.3%; 10.5% required reoperation and mortality was 5.3%. In group 1, 79.6% and 62.5% of patients at 2 and 5 years respectively managed to achieve a % EBMIL>50%. In group 2, the second stage was completed only in 8 patients (14.0%). Of the patients who did not complete the second stage, 32.2% and 5.9% achieved a % EEBMIL>100% at 2 and 5 years. Analyzing those who completed the second stage, the mean EEBMIL% was 90.5% and 93.4% at 2 and 5 years. CONCLUSIONS: Sleeve gastrectomy is a safe technique in patients with BMI<45 and effective in terms of weight loss in the short-medium term. In patients with BMI>55, a preoperative optimization aimed at reducing morbidity and mortality is necessary, as well as adequately planning the second stage, without which it is clearly insufficient.

Minimally invasive and robotic surgery in the surgical treatment of esophagogastric junction cancer. / Cirugía mínimamente invasiva y robótica en el tratamiento quirúrgico de las neoplasias de la unión esofagogástrica.

Minimally invasive surgery provides for the treatment of esophagogastric junction tumors under safe conditions, reducing respiratory and abdominal wall complications. Recovery is improved, while maintaining the oncological principles of surgery to obtain an optimal long-term outcome. It is important to have a sufficient volume of activity to progress along the learning curve with close expert supervision in order to guarantee R0 resection and adequate lymphadenectomy. Minimal invasiveness ought not become an objective in itself. Should total gastrectomy be performed, the risk of a positive proximal margin makes intraoperative biopsy compulsory, without ruling out a primary open approach. Meanwhile, minimally invasive esophagectomy has been gaining ground. Its main difficulty, the intrathoracic anastomosis, can be safely carried out either with a mechanical side-to-side suture or a robot-assisted manual suture, thanks to the 3-D vision and versatility of the instruments.

The IDEAL prospective development study format for reporting surgical innovations. An illustrative case study of robotic oesophagectomy.

BACKGROUND: The early development of innovative surgical procedures is usually reported as retrospective case series, wasting opportunities to provide useful information and introducing bias. We present a report of an innovative procedure in development, using the Prospective Development Study (PDS) format recommended by the IDEAL Collaboration. METHODS: We report the development of robotically assisted oesophagectomy by a two-surgeon team from the first robotic case onwards. Key outcomes (blood loss, robotic operating time, lymph node yield, length of stay and complications) are prospectively reported for each patient sequentially. Reasons for rejecting cases for robotic surgery are explained. All changes to technique or indication are highlighted, showing when they occurred and explaining why they were instituted. RESULTS: The first robotic oesophagectomy was attempted in December 2009. Subsequently 55 oesophagectomies were undertaken, 34 using the robot and 21 without it. Seven deliberate changes in technique occurred during the series. Nodal yield increased markedly after adopting formal mediastinal node dissection and clipping of the thoracic duct. No obvious trends were noted in other outcomes. The robot facilitated Intra-thoracic anastomosis, but mediastinal node dissection showed no advantages due to loss of haptic sensation. Complication rates, R0 rates and nodal yield were considered acceptable. DISCUSSION: Presenting the development experience in this way improved the clarity of transmission of the main learning points for other surgeons, eliminated bias from selective reporting and explained other types of selection bias. The IDEAL Prospective Development Study has clear advantages over standard case series format for presenting uncontrolled early study data from innovative procedures.

Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial.

BACKGROUND: Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less perioperative blood loss and faster patient recovery. It also maintains similar results with regard to tumor resection margins and oncological long-term survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the stomach, with a free margin of 5 to 6 cm from the tumor, combined with a lymphadenectomy. The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, it is imperative that a novel surgical technique, such as minimally invasive total gastrectomy, should be non-inferior with regard to radicality of surgery and lymph node yield. METHODS/DESIGN: The Surgical Techniques, Open versus Minimally invasive gastrectomy After CHemotherapy (STOMACH) study is a randomized, clinical multicenter trial. All adult patients with primary carcinoma of the stomach, in which the tumor is considered surgically resectable (T1-3, N0-1, M0) after neo-adjuvant chemotherapy, are eligible for inclusion and randomization. The primary endpoint is quality of oncological resection, measured by radicality of surgery and number of retrieved lymph nodes. The pathologist is blinded towards patient allocation. Secondary outcomes include patient-reported outcomes measures (PROMs) regarding quality of life, postoperative complications and cost-effectiveness. Based on a non-inferiority model for lymph node yield, with an average lymph node yield of 20, a non-inferiority margin of -4 and a 90% power to detect non-inferiority, a total of 168 patients are to be included. DISCUSSION: The STOMACH trial is a prospective, multicenter, parallel randomized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy: the conventional 'open' approach or minimally invasive total gastrectomy. TRIAL REGISTRATION: This trial was registered on 28 April 2014 at Clinicaltrials.gov with the identifier NCT02130726 .

Robot-assisted gastroesophageal surgery: usefulness and limitations.

Robot-assisted surgery overcomes some of the limitations of traditional laparoscopic surgery. We present our experience and lessons learned in two surgical units dedicated to gastro-esophageal surgery. From June 2009 to January 2013, we performed 130 robot-assisted gastroesophageal procedures, including Nissen fundoplication (29), paraesophageal hernia repair (18), redo for failed antireflux surgery (11), esophagectomy (19), subtotal (5) or wedge (4) gastrectomy, Heller myotomy for achalasia (22), gastric bypass for morbid obesity (12), thoracoscopic leiomyomectomy (4), Morgagni hernia repair (3), lower-third esophageal diverticulectomy (1) and two diagnostic procedures. There were 80 men and 50 women with a median age of 54 years (interquartile range: 46-65). Ten patients (7.7 %) had severe postoperative complications: eight after esophagectomy (three leaks-two cervical and one thoracic-managed conservatively), one stapler failure, one chylothorax, one case of gastric migration to the thorax, one case of biliary peritonitis, and one patient with a transient ventricular dyskinesia. One redo procedure needed reoperation because of port-site bleeding, and one patient died of pulmonary complications after a giant paraesophageal hernia repair; 30-day mortality was, therefore, 0.8 %. There were six elective and one forced conversions (hemorrhage), so total conversion was 5.4 %. Median length of stay was 4 days (IQ range 3-7). Robot-assisted gastroesophageal surgery is feasible and safe, and may be applied to most common procedures. It seems of particular value for Heller myotomy, large paraesophageal hernias, redo antireflux surgery, transhiatal dissection, and hand-sewn intrathoracic anastomosis.

Contribution of robotics to minimally invasive esophagectomy.

Robot-assisted surgery has the advantages of a three-dimensional view, versatility of instruments and better ergonomics. It allows fine dissection and difficult anastomoses in deep fields. Based on our experience, we try to define what are the main contributions of robotics to minimally invasive esophagectomy. From December 2009 to July 2012, we performed 24 minimally invasive esophagectomies (9 transhiatal, 5 Ivor-Lewis and 10 three-field), 16 of them robotically (8, 5 and 3, respectively). Eighteen patients (18/24 = 75 %) received neoadjuvant therapy. Nine patients (9/24 = 37.5 %) had symptomatic complications: 4 anastomotic leaks treated conservatively, one staple failure of the gastric plasty needing reoperation, one biliary peritonitis secondary to a gangrenous cholecystitis, one intrathoracic gastric migration after the only nonresectable case, one chylothorax and one patient with major cardiopulmonary complications. The median number of lymph nodes harvested was 12 ± 7. Median length of stay was 14 ± 13.5 days. Thirty-day mortality was nil. Complications were not related to the robot itself but to the complexity of both the technique and the patient. Although we found no advantages for the use of robotics during threefield minimally invasive esophagectomy, robotic mediastinal dissection during transhiatal esophagectomy can be performed safely under direct vision. Moreover, hand-sewn robotic-assisted technique in the prone position is promising and maybe the simplest way to carry out thoracic anastomosis during Ivor-Lewis esophagectomy.