Eur J Cardiothorac Surg 2004;25:1097-1101
© 2004 Elsevier Science NL
Comparison of manual and mechanical cervical esophagogastric anastomosis after esophageal resection for squamous cell carcinoma: a prospective randomized controlled trial
Hsao-Hsun Hsu,
Jin-Shing Chen,
Pei-Ming Huang,
Jang-Ming Lee,
Yung-Chie Lee*
Division of Thoracic Surgery, Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, No. 7, Chung-Shan South Road, Taipei, Taiwan, ROC
Received 2 December 2003;
received in revised form 4 February 2004;
accepted 16 February 2004.
* Corresponding author. Tel.: +886-2-231-23456x5070; fax: +886-2-339-33989
e-mail: wuj{at}ha.mc.ntu.edu.tw
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Abstract
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Objective: The use of a circular stapler in cervical esophagogastric anastomosis remains controversial. This study was to compare the postoperative and long-term results of manual and mechanical techniques for cervical esophagogastric anastomosis after resection for squamous cell carcinoma. Methods: A prospective randomized controlled trial was undertaken in 63 patients with curatively resectable squamous cell cancer of the thoracic esophagus between 1996 and 1999. Patients were randomized to receive either a hand-sewn (32 patients) or circular stapled (31 patients) cervical esophagogastric anastomosis. Results: The mean operating time was longer when the hand-sewn method was used (524 vs. 447 min, P<0.001). Anastomotic leakage was noted in seven patients (22%) in the hand-sewn group and eight patients (26%) in the stapler group (P=NS). Hospital mortality occurred in four patients (13%) of the hand-sewn group and in three patients (10%) of the stapler group (P=NS). After the operation, four patients (14%) in the hand-sewn group and five patients (18%) in the stapler group developed a benign esophageal stricture (P=NS). The mean follow-up time was 24 months, and the rates of freedom from benign stricture and survival were comparable in each group. Conclusions: Performing cervical esophagogastric anastomoses using a circular mechanical stapler had a shorter operating time and a comparable outcome to the hand-sewn method. The circular mechanical stapler could be used as an alternative for cervical esophagogastric anastomosis after resection for esophageal squamous cell cancer.
Key Words: Esophageal cancer • Anastomosis • Surgery
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1. Introduction
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After esophageal resection for carcinoma, the stomach is commonly used for restoring alimentary continuity. The success of esophagogastric anastomosis is closely correlated with the patient's outcome because early complications, such as leakage, cause significant morbidity and mortality [1]. When anastomotic stricture develops, recurrence of dysphagia defeats one of the main aims of surgery, which is to restore normal swallowing function.
Since the development of the circular mechanical stapler, there are many reports that show that the stapler could decrease the rate of leakage after esophagogastrostomy. However, the randomized controlled trials addressing this question are very limited [2–4], and the anastomotic location in many of these trials was in the thoracic cavity, where the reported results of esophageal anastomosis have been good [5].
Only one prospective randomized trail has been undertaken to evaluate the result of hand-sewn and stapled esophagogastric anastomoses in the neck [6]. In that trial, the authors reported that the stapler failed to function properly in three cases and had a higher rate of anastomosis leakage and benign stricture, and they concluded that cervical esophagogastric anastomoses must be fashioned by hand-sewn rather than stapler. However, their conclusion was not convincing because their study numbers are too small to be assessed statistically, and the results contradicted with a lot of published reports, including a meta-analysis of randomized controlled trials [2]. To clarify the controversy of circular mechanical stapler in cervical esophagogastric anastomosis, we carried out a prospective randomized trial to compare the hand-sewn method with the circular mechanical stapler method in a uniform patient population undergoing curative esophageal resection and cervical esophagogastrostomy.
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2. Methods
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Any patient who had a curatively resectable squamous cell carcinoma of the thoracic esophagus staged T1–T3 and N0–N1 on endosonography or computed tomographic scanning was eligible for inclusion. Patients who had adenocarcinoma, advanced tumor stage (T4 disease), advanced lymph node involvement or distant metastasis (M1 lymph or M1 disease), prior gastric surgery, poor pulmonary reserve (forced expiratory volume <50% of normal), or an increased cardiac risk (status postmyocardial infarction or cardiac insufficiency grade IV NYHA) were excluded from this study. Preoperative concurrent chemoradiotherapy (CCRT) with a standardized regimen (cisplatin, 5-fluorouracil, and a total dose of 3600 cGy of radiation) was allowed.
Tumor resection was performed by total thoracic esophagectomy with mediastinal lymphadenectomy through a right thoracotomy. Transhiatal blunt dissection without thoracotomy was reserved for patients with impaired pulmonary function (forced expiratory volume between 50 and 60% of normal). A gastric tube with a diameter of 3 cm was formed by resection of the lesser curvature through a midline laparotomy. The right gastroepiploic artery was carefully preserved. The gastric tube was pulled through the anterior mediastinum for end-to-side cervical esophagogastric anastomoses in all patients for ease of construction and standardization of the procedure. When cervical anastomosis was performed, patients were randomized into two groups according to their chart number, which was randomly assigned on admission, before any kind of work-up or management. All patients had a pyloric drainage procedure.
The hand-sewn anastomosis was accomplished using a double layer of interrupted sutures. In brief, the outer row of the anastomosis was carried out with interrupted horizontal mattress sutures of fine silk (4–0) across the longitudinal muscle fibers of the esophagus. The mucosa of the esophagus and stomach were then approximated with interrupted absorbable monofilament sutures (4–0 Maxon, polyglyconate; Davis and Geck, Danbury, CT). For stapled anastomosis, the ILS (Ethicon, Inc, Somerville, NJ) circular staplers were used. Because our pilot evaluation revealed that the size of the cervical esophagus of our patients was very small and that a 25-mm stapler sometimes overstretched or tore the esophagus, we used the 21-mm stapler in all the patients in the mechanical group in this study. The doughnuts were verified routinely. When they were incomplete, the anastomosis would be refashioned. Reinforcement stitches were routinely added in the muscular layer for better secure the anastomoses. All the operations were performed by our esophageal surgical team leaded by Dr Y.-C. Lee.
Perioperative morbidity and mortality, anastomotic leakage, and benign stricture rates were the main endpoint of the study. At surgery, the operative procedures and operating time were recorded. After surgery, patients were assessed for anastomotic leakage by a radiographic contrast study performed on days 7–10. Anastomotic leakage was diagnosed by (1) egress of saliva through the cervical drains, or (2) alteration of the anastomotic profile on radiographic examination. Other complications, including cardiopulmonary morbidity and septic complications that may have been related to the anastomotic leakage, the duration of stay in the intensive care unit (ICU), 30-day mortality, and hospital mortality, were also studied.
Patients were followed monthly after discharge. Endoscopic and barium swallow examinations were performed if symptoms of dysphagia developed. Diagnosis of benign anastomotic stricture was made if the 10-mm diameter flexible endoscope could not be passed and a malignant stricture was ruled out by histological examination. In the evaluation of benign stricture, patients who died in the hospital or in whom malignant recurrence developed at the anastomosis were excluded. Continuous variables, such as age or weight, were expressed as the mean±SD and analyzed by the two sample t-test. Categorical variables, such as gender or mortality, were presented by frequency (%) and analyzed by the Fisher's exact test. Freedom from stricture and overall survival were analyzed by the Kaplan–Meier method, and comparisons between the two groups were made by the log-rank test. A P-value of less than 0.05 was considered significant.
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3. Results
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From July 1996 to July 1999, a total of 81 patients (41 in the hand-sewn group and 40 in the stapler group) were enrolled in this study. Preoperative CCRT was undertaken in 51 patients. Among them, 18 patients (9 patients in each group) did not undergo surgery owing to complications of CCRT (1 in the stapler group and 2 in the hand-sewn group), progressive disease after CCRT (6 in the stapler group and 5 in the hand-sewn group), or refusal of subsequent surgery (2 in the stapler group and 2 in the hand-sewn group).
Curative resection (R0) of the tumor was performed for the remaining 63 patients through right thoracotomy (59 patients) or transhiatal blunt dissection (4 patients). After esophagectomy, patients were randomized to have an esophagogastric anastomosis constructed by the hand-sewn technique (32 patients) or by a circular stapler (31 patients). There was no crossover or conversion operation between the two groups. The demographic data of the 63 patients are listed in Table 1. The two groups did not differ in age, sex, preoperative health status, location of tumors, tumor stage, and prevalence of preoperative CCRT.
The operative procedures, duration of operation, operative complications, ICU and hospital stays, and operative and hospital mortality are summarized in Table 2. The patients who received hand-sewn anastomosis had longer duration of operation (524 vs. 447 min, P<0.001) compared with the stapler group. One patient in the stapler group had incomplete suturing and the anastomosis was re-fashioned again. After operation, clinical and radiological anastomotic leakage developed in seven patients in the hand-sewn group and in eight patients in the stapler group. All these patients were managed conservatively. Two patients in the stapler group and one patient in the hand-sewn group died within 30 days after operation. One of these patients in the stapler group died of major anastomotic leakage, and the other two patients died of pneumonia. Hospital mortality developed in four patients in the hand-sewn group and three patients in the stapler group. Among them, in two patients in the stapler group mortality was caused by anastomotic leakage. In the hand-sewn group, two patients died of pneumonia, and the other two patients died of a blood-borne infection.
There were seven patients excluded in the evaluation of benign stricture because of hospital mortality. The remaining 56 patients were followed up between 1 and 88 months (mean 24 months) during clinical visits or by telephone conversation. The mean follow-up time was 22±4.6 months for the hand-sewn group and 26±5.1 months for the stapler group (P=NS). Benign esophageal stricture was noted in four patients of the hand-sewn group and five patients of the stapler group (Table 3). The medium duration from operation to the development of benign stricture was 4.2 months in the hand-sewn group and 4.6 months in the stapler group, and all strictures occurred within 1 year after operation. The benign esophageal strictures were managed by endoscopic dilatation. One patient in the hand-sewn group had dense fibrosis at the anastomosis and received revision of the esophagogastric anastomosis using a Bakamjian island flap [7]. Using the Kaplan–Meier method, the rates of freedom from benign stricture in both groups are plotted in Fig. 1
, with 82% in the hand-sewn group being 1-year free from stricture and 81% in the stapler group (P=NS). The survival curves of the two groups are plotted in Fig. 2
. The overall 5-year survival rates are 24 and 34% in the hand-sewn and stapler groups, respectively. However, the difference between the two groups was not statistically significant.
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Fig. 1. Freedom from benign stricture in each group after mechanical or manual cervical esophagogastric anastomosis (P=NS by the log-rank test). The number of patients at risk for each 12-month period is indicated under the corresponding time.
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Fig. 2. Overall survival in each group after mechanical or manual cervical esophagogastric anastomosis (P=NS by the log-rank test). The number of patients at risk for each 12-month period is indicated under the corresponding time.
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4. Discussion
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Esophagogastric anastomoses can be fashioned by hand-sewn or with a mechanical stapling device. Although there are some prospective, randomized trials that compared manual and mechanical stapling methods, the results were not conclusive owing to heterogeneity in patient population, suturing methods, stapling instruments, the location of anastomosis, and ways in which the esophageal substitutes are prepared [1,3,4,8]. The controversy was more obvious when cervical esophagogastric anastomoses was concerned [2,6]. Compared with the ample space in the thoracic cavity, the application of circular mechanical staplers in the cervical region is not so convenient. Mishaps may happen and so the development of anastomotic leakage. That is why some authors discourage the use of circular stapler in cervical esophagogastric anastomoses [6]. We also had a patient of incomplete doughnut after anastomoses during the early stage of the study. However, the stapler mishaps did not happen after familiar with the implementation of instrument. In addition, the rates of anastomotic leakage were comparable between the two groups, indicating that the mechanical stapling is a feasible technique for cervical esophagogastric anastomoses.
Non-randomized comparisons of hand-sewn and stapled intrathoracic esophagogastric anastomoses suggested that the stapler has a greater tendency to cause benign stricture, especially in those patients who had a small stapler size [4,9–11]. However, the meta-analysis of randomized trials did not show a significant difference in anastomotic stricture for the two anastomotic methods [2]. In this study, the long-term follow-up also showed that the stricture rate between the two groups is comparable, even when a relatively smaller circular stapler (21 mm) was used. In addition, benign stricture caused by circular stapling was not more difficult for endoscopic dilatation. The possible explanations are that many factors, such as technique errors and occult ischemia of the gastric conduit, are predisposing factors for the development of benign strictures, and anastomotic method is obviously just one of these many variables [1,12]. Furthermore, the application of the stapler is usually easy and standardized such that it should not increase the incidence of technique errors.
As for the duration of operation, one meta-analysis of randomized trials showed that stapled esophagogastric anastomoses are generally quicker to perform than hand-sewn anastomoses [2]. However, the difference between operation time between the hand-sewn and stapler groups was not consistent among literature, probably because different methods of hand-sewn suture were used [3,4,8]. In our study, the duration of operation was significantly longer in the hand-sewn group. The main reason for this longer time was probably because manual anastomoses of cervical esophagogastrostomy was performed using a double-layer interrupted suturing technique rather than one-layer continuous suture. In addition, the operation time of manual method is more subjected to the influence of various factors such as intraoperative mishaps (e.g. poor alignment of the sutures) or resident performing the operation. However, the longer operation time was not associated with higher rates of morbidity or mortality when compared with the stapler group, and the clinical importance in the difference of operation time was undetermined.
Operative complications between the two groups are also comparable. Consistent with other studies [3,13], pulmonary and cardiac complications are common after esophagectomy for cancer. In our study, pulmonary complications were the leading cause of in-hospital mortality. However, we would not expect the anastomotic method to have a great impact on pulmonary and cardiac morbidity after surgery. Other issues, such as route of reconstruction and chronic illness, are more important contributors to postoperative pulmonary and cardiac complication [14]. The rate of blood-borne infection was higher in the hand-sewn group, although the difference was not statistically significant. This higher infection rate could be caused by a longer operating time or by chance.
A cervical esophagogastric anastomosis is favored by many surgeons because of the low mortality if an anastomotic leak does occur. In this study, two out of eight patients (25%) died of anastomotic failure in the stapler group whilst none out of seven patients died of anastomotic failure in the hand-sewn group. The cause of this difference remained unclear because the severity and incidence of leakage between the two groups did not significantly differ.
The route of reconstruction after esophagectomy may also influence the outcome of cervical anastomosis. In this study, the retrosternal route was selected as the routine procedure to prevent this confounding. Although it is easier to perform and may prevent dysphagia after local tumor recurrence, the retrosternal route took a longer course to the neck, which could overstretch the gastric tube and increase the tension of the anastomosis. In addition, the thoracic inlet in many of our patients was very small such that the gastric tube could be compressed by the left clavical head. The higher leakage rate in both groups could partially be attributed by this factor.
The published randomized controlled trials comparing hand-sewn and stapled esophagogastric anastomoses all used circular staplers for the stapled arm of the trials. Recently, Orringer et al. [15] had shown that cervical esophagogastric anastomosis constructed with a novel technique of side-to-side linear stapling greatly reduces the frequency of anastomotic leaks and later stricture. In their report, their leakage rate of 2.7% was significantly lower in comparison with most of the studies of hand-sewn or circular stapled anastomoses. Further prospective, randomized studies are indicated to confirm the advantages of this new technique.
In summary, although the circular stapler did not decrease the rates of leakage after cervical esophagogastric anastomosis for esophageal resection of squamous cell carcinoma, the operating time of stapling was significantly shorter, and the benign stricture rate, the surgical outcome and long-term results between the two groups were comparable. In addition, because they are relatively easy to apply and less-operator dependent, we suggest that the circular stapler could be used as an alternative method for cervical esophagogastric anastomosis.
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Abstract
1. Introduction
