Analysis of Risk factors of anastomotic leakage after minimally invasive esophagectomy with circular cervical anastomosis

doi:10.21203/rs.3.rs-4679623/v1

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Analysis of Risk factors of anastomotic leakage after minimally invasive esophagectomy with circular cervical anastomosis

https://doi.org/10.21203/rs.3.rs-4679623/v1

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OBJECTIVES

Esophagectomy is a high-risk surgical procedure with significant postoperative morbidity and mortality. Anastomotic leakage is still one of the most serious complications after anterior resection for esophageal carcinoma. This study aimed to analyze the risk factors after minimally invasive cervical anastomosis of esophageal cancer and postoperative mortality.

METHODS

This was a retrospective study of 312 minimally invasive cervical anastomosis of esophageal cancer in a single institute between 2013 and 2016. The anastomotic level and perioperative confounding factors were analyzed by univariate and multivariate logistic regression to identify potential risk factors for postoperative leakage.

RESULTS

Total 312 patients were evaluated. Overall leak rate was 10.6%. In-hospital or 30-day mortality was 0%. Only 3 patients received intensive care unit due to postoperative complications and mean hospital stay was 14.22(± 7.70) days. Univariate analysis showed that the following variables were related to the incidence of anastomotic leakage: neoadjuvant chemotherapy before operation (p = 0.007); body mass index (BMI) (p = 0.000); diabetes (p = 0.001); operation time (p = 0.006). Multivariable analysis identified diabetes [P = 0.032, odds ratio (OR) 2.637, 95% confidence interval (CI): 1.087–6.393], BMI [P = 0.003, odds ratio (OR) 1.223, 95% confidence interval (CI): 1.070–1.399] and operation time [P = 0.033, odds ratio (OR) 1.012, 95% confidence interval (CI): 1.001–1.024] as the risk factors of anastomotic leakage.

CONCLUSIONS

Diabetes, operation time and BMI are independent prognostic factors for cervical anastomotic leakage of minimally invasive esophageal cancer. Cervical anastomotic leakage will not affect the short-term survival of the patients.

Minimally invasive esophagectomy

Anastomotic leakage

Risk factors

oesophageal cancer

Esophageal carcinoma is the seventh most common and sixth most lethal malignancy worldwide (1). Surgical resection is the most important treatment option for esophageal cancer. Radical esophagectomy is still a traumatic and complex operation, and could cause many complications in the perioperative period (2). Anastomotic fistula is one of the most common and serious complications after esophageal cancer surgery, and is one of the main causes of death after esophageal cancer surgery. Therefore, early diagnosis and treatment of postoperative anastomotic leakage of esophageal cancer is of great significance to reduce the postoperative mortality of esophageal cancer (3–5). Esophageal cancer is one of the most common malignant tumors in China. Different from Western countries, squamous cell carcinoma is the main histological type of esophageal cancer patients in China. Therefore, the risk factors of anastomotic fistula may be different in China and Western countries.

At present, in most neck anastomosis circular stapler (CS) is used for tubular anastomosis because of its simplicity and low leakage rate. However, circular anastomosis still has some anastomotic leakage. The factors affecting the occurrence of anastomotic leakage after circular stapler anastomosis have not been investigated in detail (6).

Therefore, this study aimed to explore the risk factors of postoperative cervical anastomotic fistula and in-hospital mortality in Chinese patients with esophageal cancer who underwent circular instrument anastomosis in a large Chinese clinical diagnosis and treatment center for esophageal cancer. We collected clinical data of the patients with histologically confirmed esophageal squamous cell carcinoma who underwent esophagectomy and neck anastomosis with circular instrument anastomosis, and analyzed the risk factors after minimally invasive cervical anastomosis of esophageal cancer and postoperative mortality.

Patients

This retrospective study was approved by the institutional review board of the Qilu Hospital of Shandong University. All patients provided informed consent. This study included consecutive patients who had undergone esophagectomies with cervical anastomosis from January 2013 to December 2016 at the Thoracic Surgery Department of Qilu Hospital of Shandong University Cancer Center. All patients included in this study received cervical anastomosis. An end-to-side esophagogastric anastomosis was performed in the neck using circular stapled anastomotic technique.

All patients were monitored by special nurses after operation, and the incidence of anastomotic leakage was closely monitored during follow-up. Once there were signs of anastomotic stoma (including knife edge redness and swelling, elevated body temperature, chest pain, etc.), blood routine examination, upper gastrointestinal angiography and chest CT monitoring were carried out immediately to confirm the anastomotic stoma leakage.

Data collection

The clinical data of all patients were obtained from the electronic medical record system of Qilu Hospital of Shandong University, including demographics, preoperative risk factors, operation development, short-term hospitalization after operation, etc. All cases included in this study had normal liver and kidney function before operation, and none had cirrhosis. Tumors were staged according to the seventh edition of the TNM staging system of the International Union for cancer control (UICC). Preoperative neoadjuvant patients received only 2 cycles of preoperative chemotherapy. All chemotherapy patients received carboplatin / paclitaxel chemotherapy without preoperative radiotherapy. The information of anastomotic leakage and hospital stay were collected after the operation. "Total days of hospitalization" was defined as "total days from admission to discharge", and "postoperative hospitalization" was defined as "days from operation to discharge". The main measurements in this study were cervical anastomotic leakage, the in-hospital mortality rate, and the 30-day mortality rate. Secondary measurements were the length of hospital stay after surgery and the total length of hospital stay.

Surgical procedures

All operations were performed by the same team, consisted of the same surgeon and two skilled assistant surgeons. CS was performed as follows. The broken end of esophagus was clamped with a bag clamp, and sutured with a bag line. The stapler thimble was placed at the cut end of the esophagus, and the stapler thimble was fixed by a purse string suture. A 2 cm incision was created at the top of the tube stomach. When the stapler was inserted into the tube stomach, the proper position of the great curvature side of the stomach was selected for mechanical anastomosis with the stapler thimble. The incision was cut and closed on the top of the stomach (Fig. 1).

Management of anastomotic leakage

After the operation, if anastomotic leakage occurs, the neck incision must be first removed, and then fully drained. Next, chest CT should be performed to evaluate whether the leakage has entered the thoracic cavity and if required, adequate drainage of the chest and mediastinum should be performed. Patients with postoperative anastomotic leakage also received gastrointestinal decompression and adequate nutritional support (Fig. 2). The most common clinical manifestation of postoperative patients with anastomotic fistula is elevated body temperature, increased white blood cell ratio and neutrophil ratio in blood routine examination. The patients suspected of anastomotic leakage were confirmed by upper gastrointestinal radiography; In addition, most patients with anastomotic leakage need neck incision drainage, and the anastomotic leakage should be confirmed at the same time. For patients with small fistulas, as long as the blood routine showed local infection, the patients with symptoms relieved after the treatment of open drainage of neck anastomosis were classified as anastomotic fistulas. Some patients have no symptoms. Only the mediastinal drainage tube has pus drainage, which is also attributed to anastomotic leakage. The assessment of anastomotic fistula was confirmed by two senior doctors in the group.

Statistical analysis

Continuous data were expressed as mean and standard deviation. Student t-test was used to compare the average of continuous data, Pearson χ The 2 test was used to compare categorical data, except for variables with an expected value of < 5, where Fisher's exact was used to determine the statistical significance of the 5% level. The significance of different variables in the prediction of anastomotic leakage was evaluated in univariate analysis. The odds ratio and relative risk were obtained by cross listing. The covariates significantly related to the leakage in univariate analysis were input into multivariable logistic regression model.

Study population characteristics

Details of the clinicopathologic characteristics of the patients and their correlations with anastomotic leakage are presented in Table 1. From January 2013 to December 2016, a total of 312 patients underwent thoracoscopic and laparoscopic esophagogastrostomy combined with esophagogastrostomy for esophageal cancer. Total 209 patients (66.99%) were male and 103 patients (33.01%) were female; 63 patients (20.19%) had diabetes. The histopathological type of all patients included in the study was squamous cell. Among them, 124 patients (39.74%) were middle thoracic esophageal carcinoma, 23 patients (7.37%) were simple upper esophageal carcinoma, 17 patients (5.45%) were middle upper esophageal carcinoma, 56 patients (17.95%) were middle lower esophageal carcinoma, and 92 patients (29.49%) were lower esophageal carcinoma. Most patients were in stage II (91 cases) or stage III (111 cases), while 23 patients were in stage IV, 69 patients were in stage I and 18 patients were in stage 0. Total 59 patients (18.91%) received preoperative neoadjuvant chemotherapy. 33 cases (10.58%) had cervical anastomotic leakage. The total length of stay was 14.22 + 7.70 days, the length of stay of patients with anastomotic leakage was 27.36 + 10.53 days, and the length of stay of patients without anastomotic leakage was 12.67 + 5.53 days. The number of deaths among hospitalized patients was 0.

Anastomotic Leakage

In univariate analysis, the following variables were found to be related to the incidence of anastomotic leakage: whether neoadjuvant chemotherapy was performed before operation (p = 0.007); body mass index (BMI) (p = 0.000);diabetes (p = 0.001); operation time (p = 0.006). The clinical information and the results of the univariate analysis of the patients in the training dataset are listed in Table 1 and Table 2. Multivariate logistic regression analysis showed that diabetes, BMI and operation time but not preoperative neoadjuvant chemotherapy were the factors influencing the occurrence of anastomotic leakage (Table 4).

A total of 33 patients (10.6%) developed cervical anastomotic leakage. The leakage rate of cervical anastomosis in patients with diabetes was significantly higher than that in patients without diabetes (22.2% and 7.63% respectively, p = 0.001). The results are shown in Table 1. The cervical anastomotic leakage rate of patients with diabetes history of more than 5 years was significantly higher than that of patients with diabetes history of less than 5 years (37.5% and 12.82% respectively, p = 0.022). Other logistic regression analysis showed that patients with diabetes were associated with the occurrence of cervical anastomotic leakage (p = 0.032). The results are shown in Table 4.

The occurrence of anastomotic leakage prolonged the hospital stay. The total hospital stay of patients with anastomotic leakage was 27.44 ± 11.21 days, and that of patients without anastomotic leakage was 11.34 ± 4.79 days. The postoperative hospital stay of patients with anastomotic leakage was 23.36 ± 10.53 days, and that of patients without anastomotic leakage was 8.67 ± 5.53 days. The results are shown in Table 3.

Anastomotic leakage is the most serious complication after the resection of esophageal cancer. In our study, the incidence of anastomotic leakage was 10.58%, lower than that reported in other studies (7–9). Patients who visit our hospital are generally patients with relatively complex conditions, including many patients with various basic diseases. Some basic diseases will affect the healing of the patient's postoperative anastomosis. For example, diabetes is a risk factor for postoperative anastomotic leakage, but previous studies showed controversial results (10–11). Because of the progress in esophageal diagnosis and treatment, the implementation of preoperative neoadjuvant chemotherapy and other measures has caused great difference for the surgical treatment of esophageal cancer patients. In addition, due to the application of minimally invasive technology in esophageal cancer resection, the indications of esophageal cancer surgery are gradually expanding. The application of minimally invasive technology has provided surgical opportunity for some patients with basic diseases, but not all of these patients can recover smoothly after surgery, and some patients will have complications.

We conducted this retrospective study to explore the risk factors of anastomotic leakage after cervical anastomosis for esophageal cancer. In addition, we selected all relevant operative covariates for logistic analysis to identify independent risk factors for leakage as an endpoint. Univariate analysis showed that diabetes, operation time, preoperative chemotherapy and BMI were independent risk factors for anastomotic leakage. Moreover, multivariate analysis showed that diabetes, operation time and BMI were independent predictors of cervical anastomotic leakage after esophageal cancer surgery.

As we all know, compared with the non-diabetes population, the mortality rate of the diabetes population is usually higher, and the major cause of death is the large vessel disease caused by diabetes. Previous studies mainly emphasized that the severity of diabetes is the main risk factor of death. Other studies suggest that as an important preoperative parameter, diabetes may damage the healing of anastomoses and lead to anastomotic leakage due to ischemia of substitute catheters caused by vascular system damage (12–13). So far, there is no consensus on the relationship between diabetes and the risk after esophagectomy.

Some studies reported that operation time is a risk factor for anastomotic leakage after colon cancer surgery (14–15). Our study found that the operation time was also a high-risk factor for anastomotic leakage after minimally invasive esophageal cancer surgery. To some extent, the length of the operation time is caused by the degree of difficulty of the operation. Many factors can cause the degree of difficulty of the operation, such as the degree of invasion of tumor tissue to surrounding tissues, tissue adhesion caused by preoperative neoadjuvant chemotherapy, patient obesity, surgical bleeding, etc. Therefore, operation time is a comprehensive evaluation indicator and an independent risk factor to predict the occurrence of anastomotic leakage after the operation.

BMI of 18.5–20 kg/m2 is related to the postoperative mortality. A lower BMI may lead to poor nutritional status to support the recovery of postoperative complications, but a higher BMI may lead to increased load of cardiopulmonary function and increase the postoperative mortality of patients. However, few studies investigated the relationship between BMI and anastomotic leakage (16–18). Our study found that the probability of anastomotic leakage increased when BMI was more than 24 kg/m2, which was obviously not caused by nutritional status because the development of postoperative enteral nutrition has greatly reduced the impact of patient’s own nutritional status on postoperative recovery. The improvement of the precision of minimally invasive surgery also has a requirement on the BMI of patients, and the higher BMI value increases the difficulty of surgery to a certain extent. The fabrication of tubular stomach and the size of cervical anastomotic space in patients with high BMI may be different from those in patients with low BMI. In addition, the relaxation of pylorus is essential to relieve the tension of tubular stomach; It is generally believed that the excessive tension of the tubular stomach is the direct cause of anastomotic leakage caused by operation. In patients with high BMI, the visceral fat content is relatively high, which increases the difficulty of pyloric lysis to a certain extent, and increases the tension of the tubular stomach. For patients with lower BMI, the reason for anastomotic leakage should be the nutritional status. Most of the anastomotic leakage in patients with lower BMI is late fistula. Patients with lower BMI may have problems with nutrition absorption, leading to poor healing ability of anastomotic leakage.

At present, the influence of neoadjuvant therapy on anastomotic leakage of esophageal cancer is controversial. Some studies have shown that new adjuvant therapy can lead to anastomotic leakage (19–20), while others have shown no relationship between them (21). Some studies even showed that preoperative radiotherapy and chemotherapy can reduce the incidence of leakage. The general health status of patients who choose to receive preoperative new assistance is better than that of ordinary patients. Therefore, although these patients receive preoperative new assistance, the probability of postoperative anastomotic leakage is still lower, and this may be due to a reduction in the scope of surgical resection in patients with neoadjuvant therapy, which may reduce injury and the risk of anastomotic leakage (3, 22). This study showed that the incidence of anastomotic leakage was higher in patients after neoadjuvant therapy. The anastomotic method used in this study was cervical anastomosis. Compared with intrathoracic anastomosis, cervical anastomosis requires higher blood circulation supply. The probability of microvascular circulation disorder at the neck anastomosis is higher. Patients receiving neoadjuvant chemotherapy before surgery may have blood microcirculation disorder around the neck anastomosis, thus increasing the risk of anastomotic leakage. In addition, the short-term nutritional decline caused by neoadjuvant chemotherapy may be one of the reasons for postoperative anastomotic leakage. Although multivariate analysis suggested that preoperative neoadjuvant chemotherapy was not an independent risk factor for postoperative cervical anastomotic leakage, we still considered it as a risk factor.

The postoperative hospital stay of patients with anastomotic fistula was significantly prolonged, but our results showed that there was no perioperative death of patients after operation, which is related to active drainage, accurate antibiotic application and active nutrition supplement. In addition, the application of minimally invasive surgical techniques has greatly reduced the incidence of cardiopulmonary complications such as postoperative atelectasis, pulmonary infection and heart failure, leading to reduced perioperative mortality.

This study showed that anastomotic leakage can significantly prolong hospital stay, but does not increase postoperative mortality. Patients with diabetes before operation, BMI greater than 24, and longer operation time may increase the probability of anastomotic leakage. Further studies with prospective multicenter design will be necessary to confirm the predictors of cervical anastomotic leakage and short-term postoperative recurrence after esophagectomy.

Availability of data and materials: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests: The authors have no relevant financial or non-financial interests to disclose.

Funding: This study was funded by National Natural Science Foundation of China (82103546) and Natural Science Foundation of Shandong Province (ZR2020QH212 and ZR2020QH199).

Human Ethics and Consent to Participate declarations: This retrospective study was approved by the institutional review board of the Qilu Hospital of Shandong University (Approval No. KYLL-202208-094, NCT06147180:2023/11/19). All patients provided informed consent.

Acknowledgments: None.

Author Contribution: Ming Lu: Conceptualization, Methodology, Software, Writing- Reviewing and Editing. Cong Wang: Data curation, Writing- Original draft preparation. Lin Li: Visualization, Investigation. Yang Yu and Ningju Zhu: Software, Validation. Hui Tian: Writing- Reviewing and Editing

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Table 1

Clinical and pathological characteristics and their correlation with intrathoracic anastomotic leakage.
Variable	Overall (n = 312)	Leak (n = 33)	Rate (%)	P
Gender				0.846
Male	209	23	11.00%
Female	103	10	9.71%
Age				0.462
≥ 65	134	12	8.96%
< 65	178	21	11.80%
Diabetes				0.001
Yes	63	14	22.22%
No	249	19	7.63%
Tumor location				0.142
Upper thoracic esophagus	23	2	8.70%
Upper-Middle thoracic esophagus	17	0	0%
Middle thoracic esophagus	124	17	13.71%
Middle- Lower thoracic esophagus	56	2	3.57%
Lower thoracic esophagus	92	12	13.04%
Pathological TNM stage				0.613
0	18	1	5.56%
I	69	8	11.59%
II	91	10	10.99%
III	111	11	9.91%
IV	23	3	13.04%
T stage				0.939
Tis	18	1	5.56%
T1	71	8	11.27%
T2	67	7	10.45%
T3	153	17	11.11%
T4	2	0	0%
N stage				0.843
N0	169	19	11.24%
N1	75	6	8.00%
N2	42	5	11.90%
N3	22	3	13.64%
Preoperative Chemotherapy				0.007
Yes	59	12	20.34%
No	253	21	8.30%
BMI				0.000
< 18.5	16	0	0%
≥ 18.5 and < 24	187	10	5.35%
≥ 24 and < 28	89	19	21.35%
≥ 28	19	4	21.05%
ASA				0.850
I	15	1	6.67%
II	275	30	10.91%
III	22	2	9.09%
Nerve invasion				0.475
Yes	18	1	5.56%
No	294	32	10.88%
Vascular invasion				0.356
Yes	56	4	7.14%
No	256	29	11.33%

Table 2

Operative details.
Variable	Overall	No leakage	leakage	P
Operation time	221.70 ± 36.35	219.75 ± 35.38	238.18 ± 40.69	0.006
Length of stay	14.22 ± 7.70	12.67 ± 5.53	27.36 ± 10.53	0.000
Hemoglobin content	140.38 ± 14.57	140.73 ± 14.19	137.33 ± 17.43	0.205
Neutrophil count	4.22 ± 2.68	4.16 ± 2.70	4.77 ± 2.45	0.216
Lymphocyte count	1.70 ± 0.65	1.68 ± 0.55	1.85 ± 1.20	0.156
Albumin content	42.35 ± 3.63	42.36 ± 3.65	42.26 ± 2.56	0.875
Surgical bleeding volume	120.26 ± 70.90	119.30 ± 73.96	128.33 ± 35.59	0.490

Table 3

The effects of intrathoracic anastomotic leakage on hospital stay.
Variables	No leakage	leakage	P
Postoperative hospital stay (days, mean ± SD)	8.67 ± 5.53	23.36 ± 10.53	0.000
Total hospital stay (days, mean ± SD)	11.34 ± 4.79	27.44 ± 11.21	0.000
a By Mann-Whitney U test.

Table 4

Factors associated with anastomotic leakage after anterior resection for rectal cancer by multivariate analysis
Variables	Exp (B)	95% C.I. for EXP(B)	p
Age	0.994	0.942–1.049	0.818
Smoking	1.583	0.676–3.704	0.290
Diabetes	2.637	1.087–6.393	0.032
Tumor location	0.733	0.514–1.046	0.087
Pathological TNM stage	0.962	0.551–1.680	0.892
T stage	1.014	0.483–2.128	0.970
N stage	0.991	0.425–2.311	0.983
Preoperative Chemotherapy	2.382	0.916–6.191	0.075
BMI	1.223	1.070–1.399	0.003
Operation time	1.012	1.001–1.024	0.033
Surgical bleeding volume	1.001	0.996–1.007	0.640
ASA	0.690	0.199–2.391	0.558
Hemoglobin content	0.984	0.957–1.011	0.247
Albumin content	1.008	0.895–1.035	0.897

No competing interests reported.

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You are reading this latest preprint version

Analysis of Risk factors of anastomotic leakage after minimally invasive esophagectomy with circular cervical anastomosis

Status:

Version 1

Abstract

OBJECTIVES

METHODS

RESULTS

CONCLUSIONS

Figures

INTRODUCTION

MATERIALS AND METHODS

Patients

Data collection

Surgical procedures

Management of anastomotic leakage

Statistical analysis

RESULTS

Study population characteristics

Anastomotic Leakage

DISCUSSION

Conclusions

Declarations

References

Tables

Additional Declarations

Status:

Version 1