- Email: [email protected]
Robot assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer
Best Practice & Research Clinical Gastroenterology 36-37 (2018) 81e83
Contents lists available at ScienceDirect
Best Practice & Research Clinical Gastroenterology journal homepage: https://ees.elsevier.com/ybega/default.asp
Robot assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer Pieter Christiaan van der Sluis*, Richard van Hillegersberg Department of Surgery, G04.228, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands
a r t i c l e i n f o
a b s t r a c t
Article history: Received 30 October 2018 Accepted 19 November 2018
Worldwide, the standard treatment for locally advanced esophageal cancer with curative intent is perioperative chemotherapy or preoperative chemoradiotherapy followed by open transthoracic esophagectomy (OTE) with gastric conduit reconstruction. Minimally invasive esophagectomy (MIE) was developed to improve the postoperative outcome by reducing the surgical trauma, with comparable short-term oncologic results. However, MIE is a highly complex procedure associated with a long learning curve. In 2003, robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RAMIE) was developed to overcome the technical limitations of MIE. Robotic surgery benefits from a stable 3-dimensional, magnified view and articulated instruments enabling precise dissection with 7 degrees of freedom of movement. In this review, the development of RAMIE within our hospital is described using a 5-stage development process for the assessment of surgical innovation (IDEAL). © 2018 Elsevier Ltd. All rights reserved.
Keywords: Minimally invasive esophagectomy MIE Robot assisted minimally invasive esophagectomy RAMIE
Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RAMIE) In 2003, robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RAMIE) was developed in the UMC Utrecht (Utrecht, The Netherlands) to overcome the technical limitations of minimally invasive esophagectomy (MIE) [1]. Compared to conventional minimally invasive surgery, robotic surgery benefits from articulated instruments enabling precise dissection with 7 degrees of freedom of movement and a stable 3-dimensional, 10 magnified view. For the development of RAMIE by our group, a 5-stage development process for the assessment of surgical innovation (IDEAL) was recognized [2]. The optimal thoracic port positions were first tested on human cadavers in a laboratory setting. Hereafter, the first stage of the development process for the assessment of surgical innovation criteria (stage 1, Idea) was assessed with 21 patients with resectable esophageal cancer who underwent RAMIE. These 21 patients were described in a prospective cohort study in 2006 [1]. In this initial experience, RAMIE was found to be technically feasible,
* Corresponding author. E-mail address: [email protected] (P.C. van der Sluis). https://doi.org/10.1016/j.bpg.2018.11.004 1521-6918/© 2018 Elsevier Ltd. All rights reserved.
providing an effective lymphadenectomy with low blood loss [1]. In the second stage of the development process for the assessment of surgical innovation criteria (stage 2a, Development), technical feasibility and early technical modifications were described in 2009 in a prospective cohort study including 47 patients [3]. It was concluded that RAMIE was oncologically sound compared to the current standards and that operating time, blood loss and pulmonary complications might decrease with further experience [3]. In 2015, the oncological long-term follow up for RAMIE was described in a prospective cohort study including 108 patients [4]. (stage 2b, Exploration). In 95% of patients, a radical resection (R0) was achieved with a median number of 26 lymph nodes. With a median follow-up of 58 months, 5-year overall survival was 42%, median disease-free survival was 21 month and median overall survival was 29 months [4]. It was concluded that RAMIE was shown to be oncologically effective, with a high percentage of R0 radical resections and adequate lymphadenectomy. RAMIE provided good local control with a low percentage of local recurrence at long-term follow up [4]. Stage 1e2b focused on the introduction and development of a new surgical technique [1,3,4]. However, the question remained whether RAMIE was superior to the conventional open transthoracic esophagectomy, which is considered to be the gold standard for resectable esophageal cancer worldwide [5]. However,
82
P.C. van der Sluis, R. van Hillegersberg / Best Practice & Research Clinical Gastroenterology 36-37 (2018) 81e83
before the comparison between RAMIE and the open transthoracic esophagectomy could be made, the learning curve of RAMIE had to be completed. The “learning curve” for RAMIE was defined as the number of operations that must be performed by a surgeon to achieve a steady level of performance. Measures of proficiency to describe the learning curve of the proctor included operating time, blood loss, and conversion rates. It was concluded that the learning phase of RAMIE consisted of 70 procedures in 55 months and that the learning curve for RAMIE was completed before stage 3 of the IDEAL recommendations was initiated for both the proctor and the newly introduced surgeon 2 [6]. Furthermore, it was shown that structured proctoring of a second surgeon resulted in a reduction of the learning curve of 66% in the number of operations and a reduction of 76% in time [6]. Stage 3 (Assessment) of the IDEAL criteria, aims to assess effectiveness of the new technique (RAMIE) compared to the current standards. For resectable esophageal cancer, the open transthoracic esophagectomy was considered to be the gold standard worldwide in 2012. Therefore, we compared RAMIE to open transthoracic esophagectomy in a randomized controlled trial [7]. In 2012, when the trial was initiated, our center was the only center worldwide that had clearly passed the learning phase with a joint experience of >170 RAMIE procedures. As no other institution worldwide had comparable surgical expertise, it was decided to perform a single center randomized controlled trial. The trial design, rationale and the protocol were published in 2012 [7]. Between January 2012 and August 2016, 236 patients with resectable intrathoracic esophageal cancer were screened in the UMC Utrecht, of whom 138 patients were considered eligible for the ROBOT trial [8]. Finally, 112 out of 138 patients (allocation ratio 81%) were randomized in a 1:1 fashion to undergo either RAMIE or open transthoracic esophagectomy and 109 patients were included in the intention to treat analysis [8]. The primary endpoint of this randomized controlled trial was the occurrence of overall surgery related postoperative complications (MCDC grade 2) and occurred in 32 of 54 patients after RAMIE (59%) and in 44 of 55 patients after open transthoracic esophagectomy (80%) (risk ratio with RAMIE (RR) 0.74 (0.57e0.96; P ¼ 0.02)) [8]. Pulmonary complications were the most frequently observed secondary endpoint and occurred in 17 of 54 patients in the RAMIE group (32%) and in 32 of 55 patients in the open transthoracic esophagectomy group (58%) (RR 0.54 (0.34e0.85; P ¼ 0.005) [8]. Cardiac complications, which consisted mainly of cardiac arrythmias, were observed in 17 of 45 patients in the RAMIE group (22%) and in 26 of 55 patients in the open transthoracic esophagectomy group (47%) (RR 0.47 (0.27e0.83; P ¼ 0.006)) [8]. Both at discharge as well as 6 weeks post-discharge, Quality of life was higher after RAMIE compared to open transthoracic esophagectomy (mean difference 13.4 (2.0e24.7, p ¼ 0.02) and 11.1 (1.0e21.1; p ¼ 0.03), respectively). Mean postoperative pain (VAS) during the first 14 days was significantly lower after RAMIE compared to open transthoracic esophagectomy (1.86 versus 2.62, p ¼ 0.000, Figure 2) [8]. Functional recovery at postoperative day 14 was significantly better in the RAMIE group (38 of 54 patients (70%) compared to the open transthoracic esophagectomy group (28 of 55 patients, 51%) (RR 1.48 (1.03e2.13; P ¼ 0.04)) [8]. Compared to open transthoracic esophagectomy, RAMIE was associated with a significant lower percentage of overall related postoperative, pulmonary and cardiac complications. RAMIE was also associated with less blood loss, with lower postoperative pain and better functional recovery and shortterm quality of life. Oncologic outcomes, such as the percentage of radical resections (R0), the number of resected lymph nodes and disease-free and overall survival were comparable between groups and in concordance with the highest standards worldwide
nowadays [8]. Stage 4 (Long term study) of the IDEAL recommendations is currently assessed with the extension of indications for RAMIE in upper esophageal cancer with upper mediastinal lymph node metastases, cT4b esophageal cancer following downstaging with neoadjuvant therapy or other types of salvage surgery and registration of cases in the national registry database the Dutch Upper Gastrointestinal Cancer Audit (DUCA).[9] We started with a proctoring program for surgeons from other hospitals and designed a structured training program for RAMIE. We showed that proctoring of RAMIE is pivotal to reduce the learning curve of RAMIE for newly introduced surgeons and to secure a flawless introduction of this technique [7]. In order for the proctoring program to be successful for newly introduced surgeons: 2 motivated surgeons experienced in esophageal surgery and preferably in minimally invasive gastrointestinal surgery, a dedicated anesthesiologist and RAMIE specialized scrub nurses, a sufficient case load (>20 cases/year) and guaranteed access to a robotic system have to be applicable [9]. The program started with 2e3 case observations in our RAMIE expert center (UMC Utrecht), followed by a basic and dedicated esophageal robotic course in a cadaveric lab. The first case at the own hospital was always proctored by an expert. Hereafter, the proctor supervised the surgeon for the first 2e10 cases and reviewed the skills after the first 20e25 procedures [10]. We have trained many centers worldwide, that are currently performing RAMIE as their preferred surgical. Results of our proctoring program will be analyzed in the near future, to analyze whether our RAMIE results can be reproducible in other hospitals. Description of the RAMIE technique with the Da Vinci Xi using 4 arms The abdominal phase of was so far performed with a conventional laparoscopy. The new Da Vinci Xi system is specially designed for multi-quadrant surgery providing for dexterity with 4 robotic arms. With this system the abdominal phase is now also performed robotically. After the abdominal phase, the patient is positioned in left lateral decubitus position, tilted towards prone with single lung ventilation of the left lung by using a double lumen tube. Hereafter, a robotic (camera) trocar is placed in the 6th intercostal space and 8 mmHg CO2 is insufflated, followed by a robotic trocars in the 4th, 8th and 10th intercostal spaces and a 12 mm assistant trocars in the 5th intercostal space under sight. The robotic patient side cart is positioned and targeted. The trocars are docked and the robotic instruments are installed in the following order:
Robotic Robotic Robotic Robotic
arm arm arm arm
1: 2: 3: 4:
a a a a
Cadiere foreceps. robotic vessel sealer 30 endoscope permanent monopolar cautery hook
After installing the robotic arms, the procedure is started. The pulmonary ligament is divided and the parietal pleura anterior of the esophagus is dissected. The Azygos vein is divided at the level of the azygous arch using robotic Hem-O-Lok clips. The pleura is dissected up to the level above the azygos arch and the esophagus is dissected from the trachea, sparing the vagal nerve. A right paratracheal lymph node dissection is performed. The trachea, right main bronchus and superior caval vein are used as the borders for dissection with an en-bloc lymph node dissection along the left recurrent nerve. After dissection of the crossing right bronchial artery with the vessel sealer, the right main bronchus is exposed. The vagal nerve is transected at the level of the caudal border of the
P.C. van der Sluis, R. van Hillegersberg / Best Practice & Research Clinical Gastroenterology 36-37 (2018) 81e83
right main bronchus, sparing the bronchial branches. Hereafter the parietal pleura at the posterior side of the esophagus is opened from cranially to caudally along the azygos vein and the esophagus with para-esophageal lymph nodes are dissected up to the level of the aorta. Aorta esophageal branches are divided with the vessel sealer with preservation of the dorsal aortic branches. The thoracic duct is clipped with Hem-O-Lok clips at the level of the diaphragm and included in the resection specimen. The esophagus is dissected from the pericardium and dissection over the pulmonary vein is continued up to the level of the subcarinal nodes, which are dissected en-bloc. Finally. at the level of the crus, the esophagus is fully mobilized and the gastric tube can be brought up in to the chest using the Cadiere and the long tip forceps. The paraoesophageal tissue of the cranial esophagus is resected to be taken with the specimen. The esophagus is transected with the cautery hook, above the level of the azygos arc. The specimen is removed through a small incision at the location of the trocar in the 8th intercostal space. An Alexis port (Applied Medical) is used and after removal of the resected specimen, the robotic trocar is re-inserted through the Alexis port. With a Vicryl 4e0 the muscular- and mucosal layer of the esophagus are relined to prevent muscular slip of the esophageal wall during the construction of the anastomosis (‘Stay Sutures’). After alignment of the gastric tube in the former esophageal bed, the cautery hook is used to open the gastric tube. Stratafix 3e0 is used for a robotically hand sewn running end-toside esophago-gastrostomy. Hereafter the tip of the gastric tube is stapled off. A vicryl 3-0 suture is for 4 tension releasing sutures, covering the anastomosis with a rim of gastric tube. An circular omental wrap is used covering the anastomosis completely and fixed with sutures. The diaphragm is closed with a crura plasty using Mersilene 2/0. After placement of a chest tube and a Jackson pratt drain at the level of the 8th anterior port, the right lung is insufflated. Wounds are closed with a vicyl 1 and a monocryl. Discussion Together with the previous randomized trial comparing MIE to open transthoracic esophagectomy (TIME-trial) [11], results of this randomized controlled trial provide evidence to use minimally invasive surgery for patients with resectable esophageal cancer aiming at improving postoperative outcomes and quality of life with comparable oncologic results. The question rises whether RAMIE is superior to conventional minimally invasive esophagectomy. To show the benefits of RAMIE over conventional MIE in a randomized trial would require a large number of patients as differences will be subtler compared to the open surgical technique. Such a trial could only performed in a worldwide multicenter fashion, where participating surgeons should be skilled in both conventional MIE and RAMIE and for both reasons, such a randomized controlled might not be feasible. A large number of patients included in national or worldwide prospective database registries, with a defined protocol for registering complications according to the definitions stated by the Esophagectomy Complications Consensus Group (ECCG) [12] and reporting of patient comorbidities could answer the question whether RAMIE or MIE is superior to open esophagectomy or to each other. Differences between MIE and RAMIE in postoperative complications and oncologic outcomes might be marginal. Quality of life, better ergonomics for the surgeon and cost effectiveness might be important endpoints in these prospective registry studies and are encouraged to be conducted in the near future.
83
Practice points - In this single center randomized controlled trial, RAMIE resulted in a lower percentage of overall surgery-related and cardiopulmonary complications with lower postoperative pain, better short-term quality of life and a better postoperative functional recovery compared to OTE. - Oncological outcomes were comparable between RAMIE and OTE and in concordance with the highest standards nowadays. - This randomized controlled trial provides evidence for the use of RAMIE to improve short-term postoperative outcomes in patients with resectable esophageal cancer.
Research agenda - The cost-effectiveness for RAMIE compared to OTE needs to be investigated. - The long-term follow up of RAMIE versus OTE needs to investigated. - The reproducibility of the RAMIE results need to be investigated in other centers.
References [1] van Hillegersberg R, Boone J, Draaisma WA, Broeders IA, Giezeman MJ, Borel Rinkes IH. First experience with robot-assisted thoracoscopic esophagolymphadenectomy for esophageal cancer. Surg Endosc 2006;20(9): 1435e9. [2] McCulloch P, Altman DG, Campbell WB, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009;374:1105e12. [3] Boone J, Schipper ME, Moojen WA, Borel Rinkes IH, Cromheecke GJ, van Hillegersberg R. Robot-assisted thoracoscopic oesophagectomy for cancer. Br J Surg 2009;96:878e86. [4] van der Sluis PC, Ruurda JP, Verhage RJ, et al. Oncologic long-term results of robot-assisted minimally invasive thoraco-laparoscopic esophagectomy with two-field lymphadenectomy for esophageal cancer. Ann Surg Oncol 2015;22: 1350e6. [5] Haverkamp L, Seesing MF, Ruurda JP, Boone J, Hillegersberg RV. Worldwide trends in surgical techniques in the treatment of esophageal and gastroesophageal junction cancer. Dis Esophagus 2017;30:1e7. [6] van der Sluis PC, Ruurda JP, van der Horst S, Goense L, van Hillegersberg R. Learning curve for robot-assisted minimally invasive thoracoscopic esophagectomy: results from 312 cases. Ann Thorac Surg 2018;106:264e71. [7] van der Sluis PC, Ruurda JP, van der Horst S, et al. Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial). Trials 2012;13:230. [8] van der Sluis PC, van der Horst S, May AM, Schippers C, Brosens LAA, Joore JCA, Kroese AC, Haj Mohammad N, Mook S, Vleggaar FP, Borel Rinkes IHM, Ruurda JP, van Hillegersberg R. Robot-assisted minimally invasive thoracolaparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer: a randomized controlled trial. Ann Surg 2018. in press. [9] van Hillegersberg R, Seesing MF, Brenkman HJ, Ruurda J. Robot-assisted minimally invasive esophagectomy. Chirurg 2016;87:635e42. [10] Visser E, van Rossum PSN, van Veer H, Al-Naimi K, Chaudry MA, Cuesta MA, €lscher AH, Luyer MDP, Mariette C, Moorthy K, Gisbertz SS, Gutschow CA, Ho € der W, Nieuwenhuijzen GAP, Nilsson M, R€ as€ anen JV, Schneider PM, Schro Cheong E, van Hillegersberg R. A structured training program for minimally invasive esophagectomy for esophageal cancer- a Delphi consensus study in Europe. Dis Esophagus 2018:31. [11] Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet 2012;379:1887e92. [12] Low DE, Alderson D, Cecconello I, et al. International consensus on standardization of data collection for complications associated with esophagectomy: esophagectomy complications consensus group (ECCG). Ann Surg 2015;262:286e94.
Contents lists available at ScienceDirect
Best Practice & Research Clinical Gastroenterology journal homepage: https://ees.elsevier.com/ybega/default.asp
Robot assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer Pieter Christiaan van der Sluis*, Richard van Hillegersberg Department of Surgery, G04.228, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands
a r t i c l e i n f o
a b s t r a c t
Article history: Received 30 October 2018 Accepted 19 November 2018
Worldwide, the standard treatment for locally advanced esophageal cancer with curative intent is perioperative chemotherapy or preoperative chemoradiotherapy followed by open transthoracic esophagectomy (OTE) with gastric conduit reconstruction. Minimally invasive esophagectomy (MIE) was developed to improve the postoperative outcome by reducing the surgical trauma, with comparable short-term oncologic results. However, MIE is a highly complex procedure associated with a long learning curve. In 2003, robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RAMIE) was developed to overcome the technical limitations of MIE. Robotic surgery benefits from a stable 3-dimensional, magnified view and articulated instruments enabling precise dissection with 7 degrees of freedom of movement. In this review, the development of RAMIE within our hospital is described using a 5-stage development process for the assessment of surgical innovation (IDEAL). © 2018 Elsevier Ltd. All rights reserved.
Keywords: Minimally invasive esophagectomy MIE Robot assisted minimally invasive esophagectomy RAMIE
Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RAMIE) In 2003, robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RAMIE) was developed in the UMC Utrecht (Utrecht, The Netherlands) to overcome the technical limitations of minimally invasive esophagectomy (MIE) [1]. Compared to conventional minimally invasive surgery, robotic surgery benefits from articulated instruments enabling precise dissection with 7 degrees of freedom of movement and a stable 3-dimensional, 10 magnified view. For the development of RAMIE by our group, a 5-stage development process for the assessment of surgical innovation (IDEAL) was recognized [2]. The optimal thoracic port positions were first tested on human cadavers in a laboratory setting. Hereafter, the first stage of the development process for the assessment of surgical innovation criteria (stage 1, Idea) was assessed with 21 patients with resectable esophageal cancer who underwent RAMIE. These 21 patients were described in a prospective cohort study in 2006 [1]. In this initial experience, RAMIE was found to be technically feasible,
* Corresponding author. E-mail address: [email protected] (P.C. van der Sluis). https://doi.org/10.1016/j.bpg.2018.11.004 1521-6918/© 2018 Elsevier Ltd. All rights reserved.
providing an effective lymphadenectomy with low blood loss [1]. In the second stage of the development process for the assessment of surgical innovation criteria (stage 2a, Development), technical feasibility and early technical modifications were described in 2009 in a prospective cohort study including 47 patients [3]. It was concluded that RAMIE was oncologically sound compared to the current standards and that operating time, blood loss and pulmonary complications might decrease with further experience [3]. In 2015, the oncological long-term follow up for RAMIE was described in a prospective cohort study including 108 patients [4]. (stage 2b, Exploration). In 95% of patients, a radical resection (R0) was achieved with a median number of 26 lymph nodes. With a median follow-up of 58 months, 5-year overall survival was 42%, median disease-free survival was 21 month and median overall survival was 29 months [4]. It was concluded that RAMIE was shown to be oncologically effective, with a high percentage of R0 radical resections and adequate lymphadenectomy. RAMIE provided good local control with a low percentage of local recurrence at long-term follow up [4]. Stage 1e2b focused on the introduction and development of a new surgical technique [1,3,4]. However, the question remained whether RAMIE was superior to the conventional open transthoracic esophagectomy, which is considered to be the gold standard for resectable esophageal cancer worldwide [5]. However,
82
P.C. van der Sluis, R. van Hillegersberg / Best Practice & Research Clinical Gastroenterology 36-37 (2018) 81e83
before the comparison between RAMIE and the open transthoracic esophagectomy could be made, the learning curve of RAMIE had to be completed. The “learning curve” for RAMIE was defined as the number of operations that must be performed by a surgeon to achieve a steady level of performance. Measures of proficiency to describe the learning curve of the proctor included operating time, blood loss, and conversion rates. It was concluded that the learning phase of RAMIE consisted of 70 procedures in 55 months and that the learning curve for RAMIE was completed before stage 3 of the IDEAL recommendations was initiated for both the proctor and the newly introduced surgeon 2 [6]. Furthermore, it was shown that structured proctoring of a second surgeon resulted in a reduction of the learning curve of 66% in the number of operations and a reduction of 76% in time [6]. Stage 3 (Assessment) of the IDEAL criteria, aims to assess effectiveness of the new technique (RAMIE) compared to the current standards. For resectable esophageal cancer, the open transthoracic esophagectomy was considered to be the gold standard worldwide in 2012. Therefore, we compared RAMIE to open transthoracic esophagectomy in a randomized controlled trial [7]. In 2012, when the trial was initiated, our center was the only center worldwide that had clearly passed the learning phase with a joint experience of >170 RAMIE procedures. As no other institution worldwide had comparable surgical expertise, it was decided to perform a single center randomized controlled trial. The trial design, rationale and the protocol were published in 2012 [7]. Between January 2012 and August 2016, 236 patients with resectable intrathoracic esophageal cancer were screened in the UMC Utrecht, of whom 138 patients were considered eligible for the ROBOT trial [8]. Finally, 112 out of 138 patients (allocation ratio 81%) were randomized in a 1:1 fashion to undergo either RAMIE or open transthoracic esophagectomy and 109 patients were included in the intention to treat analysis [8]. The primary endpoint of this randomized controlled trial was the occurrence of overall surgery related postoperative complications (MCDC grade 2) and occurred in 32 of 54 patients after RAMIE (59%) and in 44 of 55 patients after open transthoracic esophagectomy (80%) (risk ratio with RAMIE (RR) 0.74 (0.57e0.96; P ¼ 0.02)) [8]. Pulmonary complications were the most frequently observed secondary endpoint and occurred in 17 of 54 patients in the RAMIE group (32%) and in 32 of 55 patients in the open transthoracic esophagectomy group (58%) (RR 0.54 (0.34e0.85; P ¼ 0.005) [8]. Cardiac complications, which consisted mainly of cardiac arrythmias, were observed in 17 of 45 patients in the RAMIE group (22%) and in 26 of 55 patients in the open transthoracic esophagectomy group (47%) (RR 0.47 (0.27e0.83; P ¼ 0.006)) [8]. Both at discharge as well as 6 weeks post-discharge, Quality of life was higher after RAMIE compared to open transthoracic esophagectomy (mean difference 13.4 (2.0e24.7, p ¼ 0.02) and 11.1 (1.0e21.1; p ¼ 0.03), respectively). Mean postoperative pain (VAS) during the first 14 days was significantly lower after RAMIE compared to open transthoracic esophagectomy (1.86 versus 2.62, p ¼ 0.000, Figure 2) [8]. Functional recovery at postoperative day 14 was significantly better in the RAMIE group (38 of 54 patients (70%) compared to the open transthoracic esophagectomy group (28 of 55 patients, 51%) (RR 1.48 (1.03e2.13; P ¼ 0.04)) [8]. Compared to open transthoracic esophagectomy, RAMIE was associated with a significant lower percentage of overall related postoperative, pulmonary and cardiac complications. RAMIE was also associated with less blood loss, with lower postoperative pain and better functional recovery and shortterm quality of life. Oncologic outcomes, such as the percentage of radical resections (R0), the number of resected lymph nodes and disease-free and overall survival were comparable between groups and in concordance with the highest standards worldwide
nowadays [8]. Stage 4 (Long term study) of the IDEAL recommendations is currently assessed with the extension of indications for RAMIE in upper esophageal cancer with upper mediastinal lymph node metastases, cT4b esophageal cancer following downstaging with neoadjuvant therapy or other types of salvage surgery and registration of cases in the national registry database the Dutch Upper Gastrointestinal Cancer Audit (DUCA).[9] We started with a proctoring program for surgeons from other hospitals and designed a structured training program for RAMIE. We showed that proctoring of RAMIE is pivotal to reduce the learning curve of RAMIE for newly introduced surgeons and to secure a flawless introduction of this technique [7]. In order for the proctoring program to be successful for newly introduced surgeons: 2 motivated surgeons experienced in esophageal surgery and preferably in minimally invasive gastrointestinal surgery, a dedicated anesthesiologist and RAMIE specialized scrub nurses, a sufficient case load (>20 cases/year) and guaranteed access to a robotic system have to be applicable [9]. The program started with 2e3 case observations in our RAMIE expert center (UMC Utrecht), followed by a basic and dedicated esophageal robotic course in a cadaveric lab. The first case at the own hospital was always proctored by an expert. Hereafter, the proctor supervised the surgeon for the first 2e10 cases and reviewed the skills after the first 20e25 procedures [10]. We have trained many centers worldwide, that are currently performing RAMIE as their preferred surgical. Results of our proctoring program will be analyzed in the near future, to analyze whether our RAMIE results can be reproducible in other hospitals. Description of the RAMIE technique with the Da Vinci Xi using 4 arms The abdominal phase of was so far performed with a conventional laparoscopy. The new Da Vinci Xi system is specially designed for multi-quadrant surgery providing for dexterity with 4 robotic arms. With this system the abdominal phase is now also performed robotically. After the abdominal phase, the patient is positioned in left lateral decubitus position, tilted towards prone with single lung ventilation of the left lung by using a double lumen tube. Hereafter, a robotic (camera) trocar is placed in the 6th intercostal space and 8 mmHg CO2 is insufflated, followed by a robotic trocars in the 4th, 8th and 10th intercostal spaces and a 12 mm assistant trocars in the 5th intercostal space under sight. The robotic patient side cart is positioned and targeted. The trocars are docked and the robotic instruments are installed in the following order:
Robotic Robotic Robotic Robotic
arm arm arm arm
1: 2: 3: 4:
a a a a
Cadiere foreceps. robotic vessel sealer 30 endoscope permanent monopolar cautery hook
After installing the robotic arms, the procedure is started. The pulmonary ligament is divided and the parietal pleura anterior of the esophagus is dissected. The Azygos vein is divided at the level of the azygous arch using robotic Hem-O-Lok clips. The pleura is dissected up to the level above the azygos arch and the esophagus is dissected from the trachea, sparing the vagal nerve. A right paratracheal lymph node dissection is performed. The trachea, right main bronchus and superior caval vein are used as the borders for dissection with an en-bloc lymph node dissection along the left recurrent nerve. After dissection of the crossing right bronchial artery with the vessel sealer, the right main bronchus is exposed. The vagal nerve is transected at the level of the caudal border of the
P.C. van der Sluis, R. van Hillegersberg / Best Practice & Research Clinical Gastroenterology 36-37 (2018) 81e83
right main bronchus, sparing the bronchial branches. Hereafter the parietal pleura at the posterior side of the esophagus is opened from cranially to caudally along the azygos vein and the esophagus with para-esophageal lymph nodes are dissected up to the level of the aorta. Aorta esophageal branches are divided with the vessel sealer with preservation of the dorsal aortic branches. The thoracic duct is clipped with Hem-O-Lok clips at the level of the diaphragm and included in the resection specimen. The esophagus is dissected from the pericardium and dissection over the pulmonary vein is continued up to the level of the subcarinal nodes, which are dissected en-bloc. Finally. at the level of the crus, the esophagus is fully mobilized and the gastric tube can be brought up in to the chest using the Cadiere and the long tip forceps. The paraoesophageal tissue of the cranial esophagus is resected to be taken with the specimen. The esophagus is transected with the cautery hook, above the level of the azygos arc. The specimen is removed through a small incision at the location of the trocar in the 8th intercostal space. An Alexis port (Applied Medical) is used and after removal of the resected specimen, the robotic trocar is re-inserted through the Alexis port. With a Vicryl 4e0 the muscular- and mucosal layer of the esophagus are relined to prevent muscular slip of the esophageal wall during the construction of the anastomosis (‘Stay Sutures’). After alignment of the gastric tube in the former esophageal bed, the cautery hook is used to open the gastric tube. Stratafix 3e0 is used for a robotically hand sewn running end-toside esophago-gastrostomy. Hereafter the tip of the gastric tube is stapled off. A vicryl 3-0 suture is for 4 tension releasing sutures, covering the anastomosis with a rim of gastric tube. An circular omental wrap is used covering the anastomosis completely and fixed with sutures. The diaphragm is closed with a crura plasty using Mersilene 2/0. After placement of a chest tube and a Jackson pratt drain at the level of the 8th anterior port, the right lung is insufflated. Wounds are closed with a vicyl 1 and a monocryl. Discussion Together with the previous randomized trial comparing MIE to open transthoracic esophagectomy (TIME-trial) [11], results of this randomized controlled trial provide evidence to use minimally invasive surgery for patients with resectable esophageal cancer aiming at improving postoperative outcomes and quality of life with comparable oncologic results. The question rises whether RAMIE is superior to conventional minimally invasive esophagectomy. To show the benefits of RAMIE over conventional MIE in a randomized trial would require a large number of patients as differences will be subtler compared to the open surgical technique. Such a trial could only performed in a worldwide multicenter fashion, where participating surgeons should be skilled in both conventional MIE and RAMIE and for both reasons, such a randomized controlled might not be feasible. A large number of patients included in national or worldwide prospective database registries, with a defined protocol for registering complications according to the definitions stated by the Esophagectomy Complications Consensus Group (ECCG) [12] and reporting of patient comorbidities could answer the question whether RAMIE or MIE is superior to open esophagectomy or to each other. Differences between MIE and RAMIE in postoperative complications and oncologic outcomes might be marginal. Quality of life, better ergonomics for the surgeon and cost effectiveness might be important endpoints in these prospective registry studies and are encouraged to be conducted in the near future.
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Practice points - In this single center randomized controlled trial, RAMIE resulted in a lower percentage of overall surgery-related and cardiopulmonary complications with lower postoperative pain, better short-term quality of life and a better postoperative functional recovery compared to OTE. - Oncological outcomes were comparable between RAMIE and OTE and in concordance with the highest standards nowadays. - This randomized controlled trial provides evidence for the use of RAMIE to improve short-term postoperative outcomes in patients with resectable esophageal cancer.
Research agenda - The cost-effectiveness for RAMIE compared to OTE needs to be investigated. - The long-term follow up of RAMIE versus OTE needs to investigated. - The reproducibility of the RAMIE results need to be investigated in other centers.
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