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ORIGINAL ARTICLE
Year : 2018  |  Volume : 14  |  Issue : 4  |  Page : 789-794

Comparison of the short-term clinical outcome between open and minimally invasive esophagectomy by comprehensive complication index


1 Department of Thoracic Surgery, Provincial Hospital Affiliated to Shandong University, Jinan, P.R. China
2 Department of Institute of Oncology, Provincial Hospital Affiliated to Shandong University, Jinan, P.R. China
3 Department of Thoracic Surgery; Department of Institute of Oncology, Provincial Hospital Affiliated to Shandong University, Jinan, P.R. China
4 Department of Surgery, Provincial Hospital Affiliated to Shandong University, Jinan, P.R. China

Date of Web Publication27-Jun-2018

Correspondence Address:
Jiajun Du
Department of Thoracic Surgery, Provincial Hospital Affiliated to Shandong University; Institute of Oncology, Provincial Hospital Affiliated to Shandong University; Dr. Yibing Wang, Department of surgery, Provincial Hospital Affiliated to Shandong University, Jinan
P.R. China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jcrt.JCRT_48_18

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 > Abstract 


Objective: Esophagectomies are associated with high mortality and various complications. Previous studies reported on the short-term outcomes were heterogeneous and inconsistent in comparing minimally invasive esophagectomy (MIE) with traditional open esophagectomy (OE). The objective of this study is to compare the short-term outcomes between MIE and OE calculated using Comprehensive Complication Index (CCI) which incorporates all complication severities.
Materials and Methods: We did expertise-based randomized controlled trial from September 2014 to October 2015. A total of 144 patients with resectable cancer were randomly selected to be treated by OE or MIE. The CCI was calculated using the Clavien-Dindo classification grade of all postoperative complications collected. Demographic characteristics, preoperative clinical assessment, postoperative complications, and CCI of patients were compared between both groups.
Results: Among the 144 patients included in this study, 97 underwent OE and 47 underwent MIE. Demographics, preoperative clinical assessment, and inpatient mortality in both cohorts were almost identical. Eighty-four patients (86.6%) of OE group and 26 patients (55.3%) of MIE group suffered from complications. A significant difference was observed in blood transfusion (P = 0.04), moderate and severe pain (P < 0.01), and diarrhea (P = 0.03) between two groups. There was an obvious statistical significance of CCI between OE and MIE groups (P = 0.036).
Conclusions: The CCI is a promising scoring system that could be used to assess the severity of complications after esophagectomy. MIE could improve the short-term outcomes by reducing some mild and moderate complications.

Keywords: Comprehensive Complication Index, esophageal cancer, minimally invasive esophagectomy, open esophagectomy, postoperative complication


How to cite this article:
Ma G, Cao H, Wei R, Qu X, Wang L, Zhu L, Du J, Wang Y. Comparison of the short-term clinical outcome between open and minimally invasive esophagectomy by comprehensive complication index. J Can Res Ther 2018;14:789-94

How to cite this URL:
Ma G, Cao H, Wei R, Qu X, Wang L, Zhu L, Du J, Wang Y. Comparison of the short-term clinical outcome between open and minimally invasive esophagectomy by comprehensive complication index. J Can Res Ther [serial online] 2018 [cited 2020 Nov 30];14:789-94. Available from: https://www.cancerjournal.net/text.asp?2018/14/4/789/235088




 > Introduction Top


Esophageal cancer is one of the most common and aggressive human malignancies. The incidence of esophageal cancer continued to rise during the past 20 years. In China, the morbidity and mortality are much higher than in the Western world. It was predicted that there would be about 477,900 newly diagnosed esophageal cancer cases and 375,000 patients would die from it in 2015.[1] Esophageal cancer was the 3rd most commonly diagnosed cancers and 4th leading cause of cancer death in 2015 in China.[1] Various methods and techniques have been proposed for the treatment of esophageal cancer, yet there is no consensus on the best treatment. The main curative treatment for localized and resectable esophageal cancer is esophagectomy, a procedure that can be performed in different ways.

Minimally invasive esophagectomy (MIE), aiming to reduce the morbidity of postoperative complication, was first introduced into clinical practice in 1992.[2] Almost 20 years after the introduction of MIE, there is still no consensus whether the surgical outcomes and safety or its oncological adequacy are clearly superior to outcomes following conventional open surgery. A systematic review comparing MIE with open surgery showed that perioperative mortality, anastomotic leak, chyle leak, vocal cord damage, and pulmonary complications of the two surgery techniques are similar.[3] Since esophageal cancer varies widely in tumor size, location, lymph node metastasis, and the patient's general health status, which type of resection is appropriate for each patient is still a difficult decision. They also indicated that the lack of transparency on how patients were selected for inclusion might cause selection bias and influence the results of the data presented. These are why randomized controlled trials were seldom performed. There are several ongoing enrolled randomized trials for comparison of minimally invasive and open esophagectomy (OE),[4],[5],[6] but the results have not come out yet.

Although perioperative mortality has been reduced from approximately 16%–3.2% over the past years, esophagectomy is still a procedure accompanied by major complications and a significant risk of mortality.[7],[8],[9] A meta-analysis included 122 studies about complications after esophagectomy (17 randomized trials and 105 observational studies), showing that no single complication was reported in all papers, and more than 60% of papers did not define any of their measured complications.[10] A standardized system for defining and recording complications after esophagectomy is essential to compare between centers, allow data synthesis, inform clinical decision-making, and assess relevant treatment effects. The Esophageal Complications Consensus Group created a consensus on standardized methods for defining complications and quality measures that could be collected in institutional databases and national audits with the use of the Delphi survey.[11] A standardized list of complications was created to provide a template for recording individual complications associated with esophagectomy. The consensus of standardized definitions was also achieved by the second Delphi survey for four key complications: anastomotic leak, conduit necrosis, chyle leak, and recurrent nerve palsy.

Validated methods of measuring surgical outcomes include the Clavien-Dindo [12] and Accordion systems,[13] which are similar in classifying complications into different grades according to the severity. The Clavien-Dindo classification (CDC) was first published in 1992[14] and revised to form a new five-scale classification system 12 years later,[13] with the aim of presenting an objective, simple, reliable, and reproducible way of reporting negative events after surgery. This classification has been used in many centers as a tool for quality assessment in audits and everyday practice, and it is increasingly used in the surgical literature.[15],[16],[17],[18],[19]

The Comprehensive Complication Index (CCI) was first developed in 2013 by Slankamenac et al.,[20] aiming to integrates all the negative events with their respective severity. The CCI is calculated as the sum of all complications with different severities classified by CDC which may ignore all additional complications that are equal or less severe. The CCI values range from 0 to 100; a value of 0 reflects the absence of complications, while a CCI of 100 indicates that the patient has died due to the occurrence of the complications. Several kinds of literature had confirmed that the CCI was a better parameter to identify risks in surgical patient groups.[20],[21]

In an attempt to answer this question, we carried out this expertise-based randomized controlled trial to compare MIE with the traditional OE in patients with esophageal cancer, assessing short-term outcomes of postoperative morbidity calculated by CCI.


 > Materials and Methods Top


Study design and clinical data

The 144 consecutive patients scheduled for esophagectomy from September 2014 to October 2015 at Shandong Provincial Hospital affiliated to Shandong University, were randomly selected to treat by one of two teams of surgeons with a preference for either OE or MIE. The 144 patients did not include patients who accepted neoadjuvant chemotherapy and/or radiotherapy. Patients of MIE group accepted a combined thoracoscopic and laparoscopic approach while the conventional transthoracic esophagectomy was used in OE group. The team performed MIE as a first-choice operation was capable of converting to OE when necessary. All patients accepted patient-controlled analgesia pump for 2 days, and enteral nutrition was given from the 1st or 2nd day after surgery by a nasal-duodenal tube placed during operation. The data were collected for demographic and preoperative clinical assessment including age, gender, smoking index (SI), pulmonary function, Body Mass Index (BMI), the American Society of Anesthesiologists score (ASA score), tumor type and location. All patients enrolled provided written informed consent.

All of the postoperative complications were collected according to the standardized list of complications created by the Esophageal Complications Consensus Group.[11] The CDC of the complications, postoperative tumor, node, metastasis (TNM) stage, pain score, length of stay (LOS), postoperative stay (PS), and hospital charge were described in the existing database and were used for the analyses. CCI was calculated according to the CDC (available at www.assessurgery.com).[20] Relations between the CCI and LOS, PS, hospital charge were assessed.

The parameter of an 11-point Numerical Rating Scale was used to assess pain severity (NRS; 0 “no pain” to 10 “worst pain imaginable”). Postoperative pain was described as moderate and severe pain if postoperative pain score was equal to or higher than 4 in our study. The pain score was regularly recorded twice every postoperative day (POD) at a set time. However when the patient suffered from moderate and severe pain, the pain score was also recorded, and an extra analgesic would be administrated as well as a Grade I CDC complication was recorded. The average pain score (POD 1–7) was the average of every day's highest pain score from 1st to the 7th POD.

Statistical analysis

Continuous variables were summarized with mean and standard deviation and compared between groups using Student's t-test. Categorical data were summarized with frequencies and percentages and compared between groups with a Fisher's exact test. A significance threshold of a probability value <0.05 was used. Linear regression analysis was used to compare the relation of the CCI with the LOS, PS, hospital charge. The analyses were performed using the Statistical Package for Social Sciences software, version 20.0 (IBM SPSS, NY, USA).


 > Results Top


Characteristics of the patients

Ninety-seven of 144 patients underwent a traditional OE, and the other 47 patients underwent the MIE. Two patients who were first assigned to the minimally invasive group conversed to thoracotomy because local infiltration and intraoperative hemorrhage could not be controlled under the thoracoscopic procedure. Baseline demographics and clinicopathologic characteristics, including age, gender, SI, pulmonary function, BMI, ASA score, tumor type and location, and final pathological TNM stage of the two groups were comparable [Table 1]. None of these characteristics was with obvious statistical significance between the two groups.
Table 1: Demographic and clinicopathological characteristics of 144 patients who underwent open esophagectomy or minimally invasive esophagectomy

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Morbidity and mortality

Two patients died of respiratory failure in the OE group, and no patient died in the MIE group within 90 days after surgery. The postoperative mortality did not differ significantly between the two groups (2/97 [2.1%] in OE vs. 0/47 [0%] in MIE; P = 0.45). Complications occurred in 110 patients (76.4%), and a total of 232 complications were recorded in the two groups. The occurrence of individual complications is shown in [Table 2]. Eighty-four patients (86.6%) of OE group and 26 patients (55.3%) of MIE group suffered from complications. Sixty-nine (47.9%) patients were accompanied with Grade II or even higher grade complications classified by CDC, and 13 (9.0%) patients were accompanied with Grade III or even higher grade complications [Table 3]. The incidences of complications with different CDC grades between OE and MIE are as follows: Grade I (35.1% vs. 14.9%; P = 0.022), Grade II (43.3% vs. 29.8%; P = 0.083), and grade higher than II (8.2% vs. 10.6%; P = 0.425) [Table 3].
Table 2: Type of complications that occurred in the patients of each group

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Table 3: Clavien-Dindo classification grade of analyzed patients grouped by open esophagectomy and minimally invasive esophagectomy

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Moderate and severe pain, pulmonary infection, pleural effusion, blood transfusion, and diarrhea are the most common complications. The operating time was significantly longer in MIE than in OE group (mean [SD], 320 ± 47 min vs. 252 ± 77 min, respectively; P < 0.001). Although intraoperative blood loss did not differ significantly between the two groups (mean [SD], 242 ± 241 vs. 227 ± 93 ml min; P = 0.40), blood transfusion was significantly lower for patients who underwent MIE (22.7% in the OE group vs. 8.5% in the MIE group; P = 0.04). Other complications with significant difference between the two groups (OE and MIE) were moderate and severe pain (43.3% vs. 17%; P < 0.01) and diarrhea (17.5% vs. 4.3%; P = 0.03). The incidences of pulmonary infections and pleural effusions were numerically, but not significantly higher in the OE group. There was no significant difference with regard to other postoperative complications.

Relations between comprehensive complication index and Clavien-Dindo classification with all parameters

The correlation coefficient showed close relationship between CCI and CDC (r = 0.969, P < 0.001). A Pearson correlation test showed a moderate or strong correlation of CCI and CDC with all parameters (P< 0.001). A strong correlation coefficient was found between the CCI and in-hospital charge (r = 0.639). A moderate correlation coefficient was found between the CCI and the LOS (r = 0.456), the PS (r = 0.426). The correlation coefficient was also calculated between the CDC and the above parameters [Table 4]. There was a significantly stronger correlation between CCI and in-hospital charge than between CDC and in-hospital charge. The correlation of in-hospital charge with CCI is significantly stronger than with CDC (r = 0.639 vs. r = 0.578; P < 0.001). There was an obvious statistical significance of CCI between OE and MIE groups (mean [SD], 19.16 ± 16.72 vs. 13.07 ± 14.79; P = 0.036).
Table 4: The correlation coefficients of the Comprehensive Complication Index and the Clavien-Dindo classification within-hospital charge, length of stay and postoperative stay of 144 patients, expressed as r

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 > Discussion Top


In this article, we compared two groups of consecutive patients treated either by OE or MIE. These data suggest that MIE is a safe technique and has lower overall morbidity compared with OE. The mortality rates of MIE and OE were 2.1% (2/97) and 0% (0/47), respectively, in this study, without statistical difference. As reported in a recent meta-analysis, mortality varied from 0% to 6.7% in the MIE group, and 0%–9.8% in the OE group also showed no significant differences.[22]

Overall morbidity remains at a high level of approximately 76.4% of all patients. The overall morbidities of OE and MIE were 86.6% (84/97) and 55.3% (26/47), were both higher than ever reported.[23],[24],[25] Most of the mild complications and some moderate complications were not included in their studies since no consensus on complications collection for esophagectomy then. In our study, the moderate and severe pain and blood transfusion accounted for 42% in all complications, which were seldom included in previous studies. There were no differences in severe complications (equal to or higher than CDC Grade III) between the two groups, 8.2% (8/97) in OE group versus 10.6% (5/47) in MIE group.

Moderate and severe pain rate of OE and MIE (43.3% vs. 17%; P < 0.01), and average pain score (POD 1–7) of OE and MIE (mean [SD], 2.16 ± 0.58 vs. 1.88 ± 0.54, respectively; P = 0.007), were both higher in the OE group. The previous study has confirmed that an extra administration of postoperative mu agonists analgesics related to poor prognosis in NSCLC patients.[26] The use of minimally invasive approach can significantly alleviate incision pain, and the less use of analgesics may be related to better survival.

Other major advantages of a minimally invasive approach were significantly lower rates of blood transfusion and diarrhea. Improvement in these outcome measures has been seen both in MIE study [26] and other minimally invasive procedures, including thoracoscopic lobectomy and laparoscopic surgery.[27],[28]

Previous articles showed a lower incidence of pulmonary infections after MIE than OE.[23],[24],[29] However in our study, morbidity of pulmonary infection between the two groups was 35.1% (34/97) in OE group and 21.2% (10/47) in MIE group, without statistical significance. Considering a prolonged operating time of MIE group as risk factors for postoperative pulmonary complication, MIE may play an important role to reduce pulmonary complications.

The strength of the CDC relied on the principle of grading complications based on the therapy used to treat the complication.[12] CCI incorporates all complications that are weighted for their severity based on the CDC. That may explain why both the CDC and CCI were highly related with the in-hospital charge, and the relation between in-hospital charge and CCI was much stronger than with CDC (r = 0.639 vs. r = 0.578; P < 0.001). The values of the CCI range from 0 to 100 and could be a more comparable registry method for researchers instead of an ordinal value such as the CDC.[21] As well as our study, several other articles also confirmed that the CCI was a better parameter to identify risks in surgical patient groups.[20],[21]

Grade I complication only contributes 8.7 points of CCI if it occurs alone. When the patient was accompanied with multiple complications, the contribution of Grade I complication decreases accordingly. Thus, a low-grade complication is less important, if it occurs in combination with more severe complications. Our data showed that the incidences of complications with II or higher CDC grades between OE and MIE were without an obvious statistical difference. The high morbidity of Grade I complications in the OE group contributes to the main difference of CCI between OE and MIE groups (mean [SD], 19.16 ± 16.72 vs. 13.07 ± 14.79; P = 0.036).


 > Conclusions Top


MIE could reduce the incidence of some mild and moderate complications, such as postoperative pain, blood transfusion, and diarrhea. There was no difference in severe complications (equal to or higher than CDC Grade III) between groups. The study provides evidence for the superiority of the MIE over OE with regard to short-term outcomes assessed by CCI. Further follow-up may elucidate whether the minimally invasive procedure also has advantages in disease control and long-term survival.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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  [Table 1], [Table 2], [Table 3], [Table 4]



 

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