Original Paper Received: October 13, 2013 Accepted after revision: January 15, 2014 Published online: April 23, 2014

Dig Surg 2014;31:95–103 DOI: 10.1159/000358812

Minimally Invasive Oesophagectomy: Preliminary Results after Introduction of an Intrathoracic Anastomosis Frans van Workum a Frits J.H. van den Wildenberg a Fatih Polat a Johannes H.W. de Wilt b Camiel Rosman a   

 

 

a

 

 

Department of Surgery, Canisius-Wilhelmina Hospital, b Department of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands  

 

Key Words Minimally invasive oesophagectomy · Intrathoracic anastomosis · Oesophageal carcinoma

tion of the intrathoracic anastomosis led to favourable functional results but was initially associated with considerable morbidity. Results improved after changing operative techniques, but the learning curve may also be responsible. © 2014 S. Karger AG, Basel

Abstract Background: Intrathoracic anastomosis after oesophagectomy has recently been associated with reduced functional morbidity compared to a cervical anastomosis. Methods: From January 2011 until August 2012, all operable patients were scheduled to undergo minimally invasive oesophagectomy (MIE) with intrathoracic anastomosis. Patient characteristics, complications, morbidity and mortality were prospectively registered and analysed. Results: Forty-five patients underwent MIE with intrathoracic stapled end-toside anastomosis. Major changes in operative technique were made 2 times due to non-satisfactory results, dividing the patients into 3 groups. One patient in group 1 died. The anastomotic leakage rate decreased from 44% in group 1 to 0% in groups 2 and 3 (p = 0.007). The pulmonary complication rate decreased from 67% in group 1 to 44% in group 2 (not significant, NS) and 22% in group 3 (p = 0.04). The median hospital stay decreased from 17 days in group 1 to 14 days in group 2 (NS) and 8 days in group 3 (p < 0.001). There were no stenoses, no dilatations and no patients with recurrent laryngeal nerve palsy. Conclusions: The introduc-

© 2014 S. Karger AG, Basel 0253–4886/14/0312–0095$39.50/0 E-Mail [email protected] www.karger.com/dsu

Introduction

The incidence of oesophageal carcinoma is rising rapidly [1]. Worldwide, more than 480,000 patients are diagnosed with oesophageal cancer annually [2]. Oesophageal resection with gastric tube reconstruction has historically been associated with considerable morbidity and mortality [3] but remains the most important curative treatment of oesophageal cancer. During the last decade, a strong improvement in morbidity, mortality and survival after oesophagectomy has been realized mainly due to centralization of treatment [4], minimally invasive surgical techniques [5] and neoadjuvant chemoradiation therapy [6]. Since postoperative morbidity and mortality are now acceptably low, other aspects of patient outcome that have been neglected previously, such as functional morbidity and post-operative quality of life, have become more important. Because of the improved long-term survival, these Frans van Workum Canisius-Wilhelmina Hospital Nijmegen PO Box 9015 NL–6500 GS, Nijmegen (The Netherlands) E-Mail F.vanworkum @ cwz.nl

aspects have become apparent for an increasing number of survivors. Benign stricture formation and recurrent laryngeal nerve trauma are common complications after oesophagectomy and cervical anastomosis, with an incidence of 26–42% [7–11] and around 20%, respectively [12–15]. These complications are major causes of functional morbidity causing dysphagia and hoarseness. In order to reduce dysphagia to an acceptable level, multiple dilatations are often required for patients with benign strictures of the anastomosis [11]. Moreover, recurrent laryngeal nerve palsy increases post-operative ventilation time and intensive care unit (ICU) and hospital length of stay [13]. Benign stricture formation is reported to occur less frequently after intrathoracic anastomosis, with an incidence of 0–27% [12, 14–19]. In addition, an intrathoracic anastomosis is associated with a lower recurrent laryngeal nerve trauma incidence of 0–7% [12, 14, 15, 20]. The risk of intrathoracic anastomotic leakage and its associated morbidity has discouraged surgeons from adopting intrathoracic anastomosis as the standard anastomotic procedure after oesophageal resection. However, in a recent meta-analysis in which intrathoracic anastomosis was compared to cervical anastomosis after oesophagectomy, there was no statistically significant difference in mortality or the pulmonary complication rate and intrathoracic anastomosis showed a lower incidence of anastomotic leakage [20]. Based on these findings, an intrathoracic anastomosis was introduced as the standard operative procedure after minimally invasive oesophagectomy (MIE) in our centre. The aim of this study was to analyse and present the preliminary results in a consecutive series of oesophageal cancer patients. Patients and Methods Patients and Setting From December 2010 until September 2012, all patients with oesophageal carcinoma from the level of the carina to the oesophagogastric junction who were eligible for surgery were scheduled to undergo minimally invasive (laparoscopic and thoracoscopic) oesophageal resection with intrathoracic end-to-side oesophagogastrostomy in the Canisius-Wilhelmina Hospital. To ensure a follow-up that was long enough to assess benign stricture formation, patients presenting after September 2012 were not included in this study. Before introduction of the intrathoracic anastomosis, the operative technique was minimally invasive resection with a cervical end-to-end oesophagogastrostomy. The Canisius-Wilhelmina Hospital is a large teaching hospital and is one of the two locations of the Oesophageal Centre of the Eastern Netherlands, a centre with a regional function for oesoph-

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ageal cancer surgery. Patients are referred from other hospitals and discussed weekly in a multidisciplinary team meeting. The Oesophageal Centre of the Eastern Netherlands has extensive experience with oesophageal surgery and operates on more than 60 oesophageal cancer patients each year. Introduction Process For the introduction of the new operative technique, the national guidelines for the safe introduction of new surgical techniques, composed by the Dutch association for endoscopic surgery, were followed. To determine the best operative technique to create an intrathoracic anastomosis, literature was reviewed and experts were consulted. The new operative technique was established after three surgeons with experience in laparoscopic oesophageal surgery reached consensus. Pre-operatively, patients were informed about the limited experience with the new technique. All procedures were performed by two surgeons. The operative procedures were videotaped, saved and reviewed. On post-operative day 5, a contrast CT scan of the thorax and upper abdomen was made in order to facilitate early detection of anastomotic leakage, if present. After each 5 patients, the experience with the operative technique and results from a prospective database were evaluated within the surgical team and less frequently with the intensive care and anaesthesiology departments. Changes in operative technique and peri-operative care were made if necessary. Operative Technique Patients were intubated by a single-lumen endotracheal tube and underwent a two-stage oesophageal resection. During the first stage, patients were put into the decubitus position. Laparoscopic mobilization of the stomach and lower oesophagus was performed en bloc with a lymphadenectomy including the posterior peritoneal and peri-aortic areolar tissue to the level of the celiac axis and the borders of the common hepatic and splenic arteries. A gastric tube was constructed, and a percutaneous feeding jejunostomy was created. For the second stage, patients were turned into the prone position. Thoracoscopy of the right thoracic cavity was performed after inflating CO2 up to a pressure of 8 mm Hg. The oesophagus was mobilized en bloc with its surrounding areolar tissue containing the parahiatal, paraoesophageal and subcarinal lymph nodes. After dividing the oesophagus at the level of the azygos vein, a stapled intrathoracic end-to-side oesophagogastrostomy was created. The thoracic cavity was drained by a 20- or 28-Charriere thoracic drain. The gastric tube was drained by a nasogastric tube. Because of non-satisfactory results, major changes in operative technique and peri-operative treatment were made 2 times. This divided the operated patients into 3 groups: • Group 1 – creation of an intrathoracic anastomosis with a double stapling technique using the 25-mm DSTTM EEATM OrVilTM (Covidien BV, The Netherlands) [21]. • Group 2 – creation of an intrathoracic anastomosis with a single stapling technique using the 28-mm DST EEA stapling device (Covidien). The anvil is introduced through one of the ports and is inserted into the proximal oesophagus. It is secured with 2 purse string sutures using the EndostitchTM 10-mm suturing device as well as a 3-0 V-LockTM wound closure device (Covidien). The circular stapling device is introduced into the opened cranial part of the gastric conduit, and an end-to-side

van Workum/van den Wildenberg/Polat/ de Wilt/Rosman

pleural empyema, chylothorax and clinically diagnosed pneumonia for which treatment was started. Cardiac complications are the combined incidence of clinically diagnosed arrhythmias, cardiac ischemic events and cardiac failure. Other complications are all other unintentional events harmful to the patient that can be attributed to the treatment. The total complication rate was defined as the cumulative incidence of the complications listed above. The in-hospital mortality rate was defined as mortality from any cause during the admission for oesophageal surgery and the 30-day mortality as mortality from any cause within 30 days after surgery.

Fig. 1. Diagram of the revised surgical technique (group 3) show-

ing an end-to-side oesophagogastric anastomosis with omental wrap. A = Azygos vein; Gt = gastric tube; Om = omental wrap; O = oesophagus; L = lung.

anastomosis is created, after which the defect in the cranial part of the gastric conduit is closed by a linear endostapler [22]. Additionally, a large omental wrap was applied around the anastomosis, using the entire omentum. • Group 3 – addition of dexamethasone 1 mg/kg intravenously before induction of anaesthesia and reduction of the omental wrap volume to up to 5 cm from the left gastroepiploic artery (fig. 1). Data Registration and Patient Safety Patient and tumour characteristics were recorded and entered into a prospective database. Outcome parameters, including operating times, blood loss, the number of harvested lymph nodes, R0 resection rate, anastomotic leakage rate, complication rate, re-operation rate, in-hospital mortality rate, 30-day mortality rate, ICU stay, ICU re-admission rate, hospital stay, hospital re-admission rate, the incidence of post-operative stenoses requiring dilatation and the incidence of recurrent laryngeal nerve trauma causing hoarseness, were registered. Definitions Anastomotic leakage was defined as leakage of the intrathoracic anastomosis on a CT scan with intravenous and oral contrast (‘swallow CT scan’), since this test has a higher sensitivity than conventional contrast swallow studies [23]. Proven leakage by endoscopy, re-operation or clinical leakage (drainage of ingested materials into the chest tube) was also recorded as anastomotic leakage. Recurrent laryngeal nerve trauma was defined as any patient with (partial) absence of vocal cord movement on laryngoscopy. To assess the need for endoscopic evaluation of the anastomosis in case of dysphagia, the Mellow-Pinkas score was used [24]. A score of ≥2 (able to swallow semisolid foods, liquids only or total dysphagia) prompted endoscopic evaluation. The re-operation rate is the incidence of re-operations during admission or within the first 30 days after surgery. Pulmonary complications are the combined incidence of pneumothorax,

Minimally Invasive Oesophagectomy with Intrathoracic Anastomosis

Analysis Data on patient characteristics and outcome were analysed using SPSS 18.0 software. To evaluate differences between the 3 groups for statistical significance, the χ2 or Fisher’s exact test was used for binomial variables. For continuous variables, the MannWhitney U test was used to evaluate if differences between the 3 treatment groups were statistically significant.

Results

Treatment Scheme for Patients Eligible for Surgery From December 2010 until September 2012, 70 patients were considered suitable for oesophageal resection with curative intent. After neoadjuvant chemoradiation therapy, surgery was cancelled in 10 patients due to progression, poor physical condition or patients’ preference. In 10 patients other operative techniques were used; in 2 patients a thoracolaparoscopic resection was performed above the level of the carina because of a high oesophageal carcinoma and a cervical anastomosis was created, in 3 patients a limited distal oesophageal carcinoma was resected with a laparoscopic transhiatal procedure, in 1 patient an intrathoracic side-to-side anastomosis was created after MIE and in 4 patients open procedures were performed due to previous surgery (n = 2), randomization in the TIME trial [5] (n = 1) and an unknown reason (n = 1; fig. 2). In the remaining 50 patients undergoing thoracolaparoscopic oesophagectomy with intrathoracic anastomosis, the tumour was considered irresectable in 5 patients (10%) because of growth into adjacent structures (n = 4) and the presence of liver metastases (n = 1). In 45 patients, MIE with an intrathoracic end-to-side anastomosis was performed. The abdominal conversion rate was 11% and was due to adhesions (n = 4) and intra-operative rupture of the gastric tube (n = 1). There were no thoracic conversions (fig. 2). Patient and Tumour Characteristics The tumour bulk was found to be in the middle third of the oesophagus in 2 patients (4%), in the distal third in 37 patients (82%) and at the level of the oesophDig Surg 2014;31:95–103 DOI: 10.1159/000358812

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70 patients eligible for surgery Surgery cancelled (n = 10) – Progression (n = 4) – Patient’s choise (n = 4) – Poor physical condition (n = 2)

60 patients undergoing surgery

50 patients undergoing MIE with ITA

Other surgical plan (n = 10) – Open TTE – TIME trial (n = 1) – Open TTE – previous surgery (n = 1) – Open THE – previous surgery + physical condition (n = 1) – Open THE – unknown (n = 1) – Laparoscopic transhiatal – limited distal carcinoma (n = 3) – Thoracolaparoscopic with CA – resection to above the carina (n = 2) – Thoracolaparoscopic with S-S ITA (n = 1) Irresectable peri-operatively (n = 5) – Growth into adjacent structures (n = 4) – Liver metastases (n = 1)

45 patients MIE with ITA performed

No conversions to thoracotomy Conversion to laparotomy (n = 5) – Adhesions (n = 4) – Gastric tube rupture (n = 1)

Fig. 2. Surgical treatment for patients eligible for surgery from December 2010 to August 2012. ITA = Intrathoracic anastomosis; CA = cervical anastomosis; S-S = side-to-side; TTE = transthoracic oesophagectomy; THE = transhiatal oesophagectomy.

agogastric junction in 6 patients (13%). Patient and tumour characteristics were similar between the 3 groups (table 1). Operative and Histological Parameters Median blood loss was 255 ml (range 100–1,700 ml), and median operating time was 296 min (range 191–378 min). A radical resection was performed in 42 patients (93%), and the median number of harvested lymph nodes was 17 (range 5–48; table 2). Morbidity and Mortality Group 1 In the first group (n = 9), the intrathoracic anastomosis was created by a double stapling technique using the OrVil device. Four patients (44%) developed an anastomotic leakage requiring re-operation, subsequent to which 1 patient died 14 days after surgery from sepsis, myocardial infarction and a major stroke. Six patients (67%) developed pulmonary complications; 5 patients (56%) developed cardiac complications, and the total complication rate was 89%. 98

Dig Surg 2014;31:95–103 DOI: 10.1159/000358812

Median ICU stay was 9 days, and 3 patients (33%) were readmitted to the ICU. Median hospital stay was 17  days, with a re-admission rate of 1 out of 9 (11%; table 2). In response to these non-satisfactory results and the high incidence of anastomotic leakage, it was hypothesized that the double stapling technique could have resulted in tissue necrosis lateral from the stapled rings, and the operative technique was changed. Group 2 In the second group (n = 18), the intrathoracic anastomosis was created by a single stapling technique. In addition, a large volume of omentum was wrapped around the anastomosis. None of the 18 patients developed an anastomotic leakage (p = 0.007). There was no in-hospital mortality, but 1 patient died 25 days after surgery of massive hemorrhage from a gastro-aortic fistula at the level of the anastomosis requiring emergency surgery (not significant, NS). The post-operative course of this patient was complicated by chyle leakage, and this was managed conservatively with total parenteral feeding during 6 days. A van Workum/van den Wildenberg/Polat/ de Wilt/Rosman

Table 1. Patient and tumour characteristics

Number Mean age (range), years Sex Male Female ASA classification 1 2 3 4 Tumour location Mid-oesophagus Distal oesophagus OGJ Tumour histology Adenocarcinoma SCC Neoadjuvant therapy CRT Chemotherapy None

Group 1

Group 2

Group 3

Total

p value

9 66 (54–75)

18 65 (34–81)

18 62 (40–80)

45 64 (34–81)

NS

8 (89) 1 (11)

15 (83) 3 (17)

15 (83) 3 (17)

38 (84) 7 (16)

NS

0 (0) 7 (78) 2 (22) 0 (0)

0 (0) 13 (72) 5 (28) 0 (0)

4 (22) 12 (67) 2 (11) 0 (0)

4 (9) 32 (71) 9 (20) 0 (0)

NS

0 (0) 8 (89) 1 (11)

0 (0) 16 (89) 2 (11)

2 (7) 13 (73) 3 (20)

2 (4) 37 (82) 6 (13)

NS

5 (56) 4 (54)

16 (89) 2 (11)

15 (83) 3 (17)

36 (80) 9 (20)

NS

9 (100) 0 (0) 0 (0)

16 (89) 2 (11) 0 (0)

16 (89) 2 (11) 0 (0)

41 (91) 4 (9) 0 (0)

NS

Values represent numbers of patients with percentages in parentheses, except where indicated otherwise. ASA = American Association of Anesthesiologists; OGJ = oesophagogastric junction; SCC = squamous cell carcinoma; CRT = chemoradiation therapy; NS = not significant.

Table 2. Outcome

Number Median blood loss, ml Median operating time, min R0 resection rate, n Median number of lymph nodes Anastomotic leakage, n

Group 1

Group 2

Group 3

Total

9 200 (100–350) 277 (216–333) 9 (100) 14 (5–25) 4 (44)

18 250 (100–1,150) 320 (262–378) 18 (100) 18 (8–33) 0 (0)

18 280 (100–1,700) 273 (191–346) 15 (83) 20 (10–48) 0 (0)

45 255 (100–1,700) 296 (191–378) 42 (93) 17 (5–48) 5 (11)

Re-operation rate, n Pulmonary complications, n Cardiac complications, n Other complications, n Complication rate, n

4 (44) 6 (67) 5 (56) 2 (22) 8 (89)

In-hospital mortality, n 30-day mortality, n Median ICU stay, days

1 (11) 1 (11) 9 (4–22)

0 (0) 1 (6) 7 (1–71)

0 (0) 0 (0) 2 (1–14)

1 (2) 2 (4) 5 (1–71)

3 (33) 17 (10–44)

4 (22) 14 (8–148)

1 (6) 8 (6–27)

8 (18) 12 (6–148)

ICU re-admission rate, n Median hospital stay, days Hospital re-admission rate, n

1 (11)

3 (17) 8 (44) 5 (28) 6 (33) 14 (78)

3 (17)

1 (6) 4 (22) 3 (17) 2 (11) 6 (33)

3 (17)

7 (16) 18 (40) 13 (29) 10 (22) 28 (62)

p values

group 2 vs. 3: p = 0.007 group 1 vs. 2: p = 0.007 group 1 vs. 3: p = 0.007 group 1 vs. 3: p = 0.03 group 1 vs. 3: p = 0.04 group 1 vs. 3: p = 0.01 group 2 vs. 3: p = 0.007 group 1 vs. 3: p < 0.001 group 2 vs. 3: p = 0.001 group 1 vs. 3: p < 0.001 group 2 vs. 3: p < 0.001

7 (16)

Values in parentheses represent ranges or percentages, as appropriate. All statistically significant differences between two groups are listed in the p value column.

Minimally Invasive Oesophagectomy with Intrathoracic Anastomosis

Dig Surg 2014;31:95–103 DOI: 10.1159/000358812

99

% 100

p = 0.01

Group 1 Group 2 Group 3

90 80

NS p = 0.007 p = 0.04 NS

70 60

p = 0.007

50

p = 0.007 NS

NS

p = 0.03 NS

NS

40 30 20 10 0

Anastomotic leakage rate

Re-operation rate

Pulmonary complication rate

Total complication rate

Fig. 3. Complication rates.

p < 0.001 NS

Median hospital stay (days)

Median ICU stay (days)

10

p < 0.001

p = 0.001

8 6 4 2 0

Group 1

Group 2

Group 3

NS

20

p < 0.001

15 10 5 0

Group 1

Group 2

Group 3

Fig. 4. ICU stay and hospital stay.

contrast swallow CT scan 4 days post-operatively showed no signs of anastomotic leakage. The re-operation rate was 17% (NS). Eight patients (44%) developed pulmonary complications (NS); 5 patients (28%) developed cardiac complications (NS), and the total complication rate was 78% (NS). Median ICU stay was 7 days (NS), with an ICU re-admission rate of 4 out of 18 patients (22%, NS), and median hospital stay was 14 days (NS), with a re-admission rate of 3 out of 18 patients (17%, NS; table 2, figure 3 and 4). Despite the diminished incidence of anastomotic leakage, the pulmonary complication rate remained high. We hypothesized that the large volume of omentum might impair post-operative pulmonary function and that this might be a cause of the high pulmonary complication rate. Group 3 In the third group (n = 18), the volume of the omental wrap was reduced (fig. 1), and pre-operative intravenous administration of 1 mg/kg dexamethasone was added to the peri-operative treatment regimen. 100

Dig Surg 2014;31:95–103 DOI: 10.1159/000358812

None of the 18 patients developed an anastomotic leakage (p = 0.007 compared to group 1); there was no in-hospital or 30-day mortality (NS), and the re-operation rate decreased to 6% (p = 0.03 compared to group 1 and NS compared to group 2). Four patients (22%) developed pulmonary complications (p = 0.04 compared to group 1 and NS compared to group 2); 3 patients (17%) developed cardiac complications (NS), and the total complication rate was 33% (p = 0.01 compared to group 1 and p = 0.007 compared to group 2). Median ICU stay and median hospital stay were 2 days (p < 0.001 compared to group 1 and p = 0.001 compared to group 2) and 8 days (p < 0.001 compared to group 1 and group 2), respectively. One patient was re-admitted to the ICU (6%, NS), and 3 patients (17%) were re-admitted to the hospital (NS; table 2, figure 3 and 4). Functional Results For this group of 45 patients, median follow-up was 11 months (range 2–23 months). There were no cases of post-operative hoarseness. Furthermore, no patients devan Workum/van den Wildenberg/Polat/ de Wilt/Rosman

veloped the inability to swallow solid foods, there were no anastomotic stenoses and no anastomotic dilatations were performed.

With an increasing number of patients surviving oesophagectomy, the importance of a functional result is increasing. Previous studies have reported a low anastomotic stricture rate after intrathoracic anastomosis [12, 14–19]. However, the laparoscopic creation of an intrathoracic anastomosis is a technically challenging procedure, and new anastomotic techniques aiming for functionality should not interfere with patient safety. In the present series, despite the extensive experience in laparoscopic oesophageal surgery with the stapling devices that were used, the introduction of the intrathoracic anastomosis after MIE initially resulted in high morbidity. In response, major changes in the treatment protocol were made 2 times. The change in anastomotic technique from double stapling with the OrVil device to single stapling using a 28-mm EEA stapler was based on the hypothesis that the double stapling technique could have resulted in tissue necrosis lateral from the stapled rings. However, no reports confirming this hypothesis were found, and in the literature, the use of the OrVil device after oesophagectomy with gastric tube reconstruction is associated with an anastomotic leakage rate of 2.7–10% [25–27]. The 4 anastomotic leaks (44%) in the 9 patients in whom the transoral stapler was used in this series may alternatively be explained by the small sample size or a learning curve in the laparoscopic creation of stapled intrathoracic anastomoses. The application of an omental wrap, which was introduced at the same time as the change in stapling technique, has been associated with improved patient outcomes in the literature. A recent meta-analysis including 449 patients undergoing transhiatal (33%) or transthoracic (67%) oesophagectomy compared the effect of an omental wrap on the incidence of anastomotic leakage. The anastomotic leakage rate was 2% in the group with an omental wrap and 9% in the group without an omental wrap (risk ratio 0.22, 95% CI 0.08–0.58). In the subgroup with an intrathoracic anastomosis, this difference did not reach statistical significance (risk ratio 0.19, 95% CI 0.03– 1.03). However, this can possibly be explained by a generally lower anastomotic leakage rate after intrathoracic anastomosis since the relative risk ratio is low and more patients might be needed to establish a statistically significant difference [28].

In the third group, the omental wrap volume was reduced since the pulmonary complication rate remained high, and it was hypothesized that a large omental volume might impair pulmonary function, although no reports confirming this hypothesis were found in the literature. Concomitant with the reduction of omental wrap volume, pre-operative intravenous administration of dexamethasone was introduced, since this has been associated with a reduction of post-operative complications. A meta-analysis on the benefits of administration of glucocorticoids before oesophagectomy showed a statistically significant improvement of various end points in the corticosteroids group, including the incidence of respiratory complications, anastomotic leakage, sepsis and cardiovascular dysfunction, and a reduction in hospital length of stay was found. However, the studies in this meta-analysis are of moderate methodological quality, and the pre-operative intravenous administration of glucocorticoids therefore remains debatable [29]. In our study, the incidence of anastomotic leakage, other complications and length of stay decreased significantly after these treatment adjustments. Unfortunately, we were unable to determine what factor caused the improvement in patient outcome, because 2 (peri-)operative factors were changed at the same time. Another limitation is that the prospective data were retrospectively analysed, and no explicit analysis plan was made before the onset of this study. A third factor that is likely to have contributed to the improvement in patient outcome is the learning curve. To our knowledge, this is the first report on the learning curve after the transition from a cervical to an intrathoracic anastomosis in patients undergoing MIE. Although we cannot establish to what extent the learning curve contributed to the improvements in outcome from our data, this finding should be taken into consideration when making the transition from cervical to intrathoracic anastomosis in patients undergoing MIE. The observation that a prospective outcome database and pre-defined evaluations led to early changes in the treatment protocol and an associated improvement in patient outcome underlines the importance of a standardized approach to evaluating results after implementation of new surgical techniques. In this series of 45 patients with an intrathoracic anastomosis after MIE, post-operative stenoses were not observed, and as a consequence no dilatations were performed. In a prospective series of 607 patients with a cervical anastomosis, the incidence of anastomotic stenosis

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Discussion

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and dilatation for benign strictures was 41.7% [13], which is in accordance with other publications reporting an incidence of 26–42% [8–11]. Although the present study is not comparative, the incidence of stricture formation and dilatation after an intrathoracic anastomosis seems significantly lower than that reported after a cervical anastomosis. Furthermore, the anastomotic leakage rate was low, and there were no cases of recurrent laryngeal nerve palsy, although some cases may have been missed since laryngoscopy was performed only after clinical suspicion of recurrent laryngeal nerve dysfunction. This is important, since recurrent laryngeal nerve trauma is associated with increased ventilation time and an increased intensive care and hospital length of stay [13]. A retrospective cohort study by Luketich et al. [22] included 530 patients undergoing MIE with intrathoracic anastomosis and also reported favourable results. The incidence of recurrent laryngeal nerve trauma was 1%; anastomotic leakage requiring re-operation occurred in 4% of patients, and 30-day mortality was 0.9% [22]. A recent meta-analysis included 4 randomized controlled trials comparing outcome after cervical or intrathoracic anastomosis [20]. The incidences of anastomotic leakage and recurrent laryngeal nerve palsy were statistically significantly lower in the intrathoracic anastomosis group. In this meta-analysis, no difference was observed in the incidence of benign stricture formation. However, the 4 randomized controlled trials included a limited number of patients, and none of the

randomized controlled trials was specifically targeted at detecting a difference in the incidence of benign stricture formation or dilatation [12, 14–16]. A randomized controlled trial specifically targeted at investigating whether an intrathoracic anastomosis is associated with a lower anastomotic stricture and dilatation rate compared to a cervical anastomosis is therefore warranted.

Conclusions

The introduction of the intrathoracic anastomosis after MIE was initially associated with considerable morbidity. Results improved after changing operative technique and peri-operative care, but the learning curve may also be responsible for the improved outcome. In this series of 45 patients undergoing MIE with intrathoracic anastomosis, no stenoses were observed and no dilatations were performed. To evaluate whether there is a significant difference in functional outcome between cervical and intrathoracic anastomoses, a randomized controlled trial is warranted. Disclosure Statement No funds were received in support of this study. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this paper.

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