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DOI: 10.1055/a-1149-1741
Endoscopic vacuum therapy versus stenting for postoperative esophago-enteric anastomotic leakage: systematic review and meta-analysis
Abstract
Background Esophageal anastomotic leakage still represents a challenging complication after esophageal surgery. Endoscopically placed self-expandable metal stents (SEMS) are the treatment of choice, but since the introduction of endoscopic vacuum therapy (EVT) for esophageal leakage 10 years ago, increasing evidence has demonstrated that EVT might be a superior alternative. Therefore, we performed a systematic review and meta-analysis to compare the effectiveness and related morbidity of SEMS and EVT in the treatment of esophageal leak.
Methods We systematically searched for studies comparing SEMS and EVT to treat anastomotic leakage after esophageal surgery. Predefined end points including outcome, treatment success, endoscopy, treatment duration, hospitalization time, morbidity, and mortality were assessed and included in the meta-analysis.
Results Five retrospective studies including 274 patients matched the inclusion criteria. Compared with stenting, EVT was significantly associated with a higher rate of leak closure (odds ratio [OR] 3.14, 95 % confidence interval [CI] 1.23 to 7.98), more endoscopic device changes (pooled median difference of 3.09; 95 %CI 1.54 to 4.64]), a shorter duration of treatment (pooled median difference –11.90 days; 95 %CI –18.59 to –5.21 days), and a lower mortality rate (OR 0.39, 95 %CI 0.18 to 0.83). There were no significant differences in short-term and major complications.
Conclusions Owing to the retrospective quality of the studies with potential biases, the results of the meta-analysis must be interpreted with caution. However, the analysis indicates the potential benefit of EVT, which should be further investigated with standardized and prospectively collected data.
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Introduction
Esophageal anastomotic leakage remains the most feared complication of esophagogastric surgery owing to the high rate of fatal outcomes [1] [2] [3] [4]. In recent decades, surgical techniques and perioperative therapy have been extensively optimized, thus significantly decreasing surgery-related mortality and morbidity [5] [6] [7] [8] [9].
While the treatment of cervical anastomotic leakages can usually be managed by simple wound drainage, the optimal treatment strategy for intrathoracic and abdominal esophageal leakage remains controversial, ranging from conservative to radical surgical treatments [2] [10] [11] [12] [13]. In the case of early leakage or conduit necrosis, most authors recommend surgery as a primary approach [14] [15] [16] [17] [18]. In the past, surgical revision and repair, re-anastomosis or even resection of the conduit were the treatments of choice, even in cases of leakage in the first few days. More recently, nonsurgical, radiologic-interventional or endoscopic treatments for contained leakage are more commonly used, resulting in different treatment schemes [14] [15] [19] [20] [21].
In particular, the endoscopic approach with self-expandable metal stents (SEMS), which cover the leak and remain in position until healing, seems to be the standard treatment in the management of anastomotic leakage, with a success rate of approximately 83 % (range 50 % – 100 %) [22] [23] ([Fig. 1]). SEMS have been shown to be an appropriate treatment in cases of anastomotic leakage. A recent retrospective study by Plum et al. assessing 70 patients with anastomotic leakage after Ivor Lewis esophagectomy showed a sealing success rate of 70 %, with a better survival rate in the first year after surgery for patients with successful treatment [24]. Nevertheless, to control pleural infection and sepsis, concomitant percutaneous drainage of abscesses is strongly recommended.
Since its introduction in 2008 by Wedemeyer et al., endoscopic vacuum therapy (EVT) has also had an increasing role in the treatment of anastomotic leakage after esophagectomy ([Fig. 1]) [25]. Vacuum-assisted closure therapy is now a well-established technique, and is used to promote the healing of wounds by creating subatmospheric pressure through a polyurethane sponge, thereby aspirating wound secretions, stimulating the granulation process, and reducing bacterial proliferation [26]. In contrast to SEMS therapy, continuous fluid collection is one of the main advantages of EVT. By reducing the need for percutaneous or surgical drainage of fluid collections, EVT may also prevent the complications related to these procedures [27]. EVT exploits the healing potential of vacuum therapy by positioning the sponge endoscopically in or on the leak. The sponge is connected to a continuous source of negative pressure (up to –125 mmHg) through a nasogastric tube. The sponge is normally changed every 72–96 hours, although there is no evidence yet regarding the best changing interval [28]. Recent studies have shown a success rate of EVT ranging from 66 % to 100 % [29] [30].
The evidence for the different therapeutic approaches in the treatment of anastomotic leakage after esophagectomy is poor, as only a few retrospective studies with small patient numbers comparing EVT and SEMS have been published. Recently, Berlth et al. published a study with a large and homogeneous cohort of patients, which significantly increased the evidence supporting these therapies [31]. Other techniques, such as endoscopic clipping or suture techniques, have been reported in case series only. Therefore, the optimal strategy is still under debate. To improve the current evidence, we performed a systematic review and meta-analysis of the currently available literature comparing EVT with SEMS placement as treatments for intrathoracic or abdominal esophago-enteric leakage after esophagectomy, in order to assess the clinical effectiveness and related morbidity of these two treatments.
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Methods
Inclusion criteria
We considered prospective and retrospective studies of patients undergoing gastric or esophageal resection and intrathoracic/mediastinal esophago-enteric anastomosis. Eligible interventions were leakage therapy with EVT compared with endoscopic stenting.
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Outcomes
The primary outcome was the rate of successful leak closure. Secondary outcomes were mortality, ICU and hospitalization time (in days), complications, median duration of endoscopic therapy (in days), and number of endoscopic treatments (stent and sponge changes).
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Search strategy
A systematic review was performed according the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) checklist [32].
We searched for published and unpublished trials without language restrictions using the Cochrane central register of controlled trials (central) and MEDLINE (1 January 2008 to 8 February 2019). Searches were carried out using medical subject headings and free-text words in combination with the search strategy for randomized controlled trials.
The proposed search strategy for MEDLINE (Ovid interface), which was modified for other databases, was: 1. EVT OR vacuum OR sponge. 2. stent OR SEMS. 3. #1 AND #2.
In addition, we searched the reference lists of articles retrieved by the search and contacted experts in the field to obtain additional data. We also searched relevant journals and conference abstracts to address the issue of publication bias.
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Data collection and analysis
The titles and abstracts of the manuscripts were independently assessed by two investigators (M.T. and P.S.). We excluded studies that clearly did not meet the inclusion criteria and evaluated the full texts of all possibly relevant articles to determine eligibility. Disagreements were resolved by consultation with a third investigator (K.K.).
Independently, the following data were retrieved: authors, year of publication, country, inclusion and exclusion criteria, study methodology, number of treated patients in each group, age and sex of patients, underlying disease, type of resection and reconstruction, neoadjuvant therapy, intervention details, duration of endoscopic treatment, number of endoscopic sessions, risk of bias, and outcomes including endoscopy-related complications, closure rate, overall hospitalization, and in-hospital mortality. We corresponded with study investigators for further data on methods and results, as required.
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Study quality
The two investigators evaluated the risk of bias using the ROBINS-I score, validating each grade of confounding, selection, classification of and deviation from intervention, missing data, outcome measurement, and selection of reported results [33]. In cases of disagreement, investigators discussed the character of the study and reached an agreement.
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Statistical analysis
The treatment effect was measured with odds ratios (ORs) for dichotomous variables and median differences for continuous variables. The homogeneity of effect sizes among studies being pooled was assessed with the I2 statistic. A meta‐analysis was conducted regardless of the level of homogeneity. Dichotomous outcomes were pooled using the Mantel–Haenzsel method under a random‐effects model. Pooled-effect measures were calculated with 95 % confidence intervals (CIs). Estimation of pooled medians was performed using the quantile estimation method [34].
All statistical analyses were done with the statistical software package R [35] version 2.6.1, the R-packages metaphor [36] version 2.1 – 0, and metamedian [37] version 0.1.4. Sensitivity analyses were planned on the basis of trial quality and the methods of the meta‐analysis, but because of the small number of studies available for meta‐analysis, this was not performed.
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Results
Description of studies
A total of 320 publications were found using the search strategy. After removing 13 duplicate records, we screened the titles and abstracts of 307 records and discarded 266 records, as they did not meet the inclusion criteria. We obtained the full text of 41 articles for in‐depth review and excluded 36, leaving five retrospective studies to be included in this review [31, 38–41]. We checked the reference lists of included studies, key textbooks, and previous systematic reviews for potentially relevant references, but found no further relevant studies. We did not find any ongoing studies. The PRISMA flow diagram is presented in [Fig. 2].
Five retrospective studies, four from Germany and one from South Korea, were included in the final analysis. The studies included 274 patients with esophageal leakage in the analysis (range 18–111). Patient characteristics are summarized in [Table 1].
|
Study, initial treatment method [ref.] |
Patients, n |
Female, n (%) |
Age, median (range), years |
Oncologic resection, % |
Neoadjuvant therapy, % |
Etiology: surgical anastomotic leak, % |
(Sub-)total esophagectomy, % |
Reconstruction type esophagogastrostomy, % |
Cervical leakage, n (%) |
|
Brangewitz 2013 Germany [38] |
|||||||||
|
32 |
4 (13) |
63 (45–84) |
88 |
56 |
94 |
44 |
– |
|
|
39 |
9 (23) |
62 (32–78) |
74 |
15 |
79 |
69 |
– |
|
|
Schniewind 2013 Germany [41] |
|||||||||
|
17 |
– |
– |
– |
– |
100 |
100 |
– |
3 (18) |
|
12 |
– |
– |
– |
– |
100 |
100 |
– |
1 (8) |
|
Mennigen 2015 Germany [40] |
|||||||||
|
15 |
1 (7) |
56 (42–76) |
100 |
73 |
100 |
100 |
100 |
0 (0) |
|
30 |
9 (30) |
66 (40–92) |
93 |
43 |
100 |
100 |
100 |
0 (0) |
|
Hwang 2016 South Korea [39] |
|||||||||
|
7 |
2 (29) |
71 (63–78) |
100 |
– |
100 |
71 |
– |
0 (0) |
|
11 |
2 (18) |
67 (55–81) |
100 |
– |
100 |
36 |
– |
1 (9) |
|
Berlth 2018 Germany [31] |
|||||||||
|
34 |
5 (15) |
65 (43–84) |
100 |
53 |
100 |
74 |
74 |
0 (0) |
|
77 |
14 (18) |
64 (43–88) |
100 |
65 |
100 |
88 |
88 |
1 (1) |
EVT, endoscopic vacuum therapy; SEMS, self-expandable metal stent.
1 Percentages relate to the total number of patients in each initial treatment group per study.
All studies compared EVT with endoscopic stenting; one study also included surgical revision (Schniewind et al. [41]). All but one study [41] reported the primary outcome of healing rate after endoscopic therapy. Reported secondary outcomes were mortality, hospitalization time, complications, and median duration of endoscopic therapy.
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Quality of included studies
We performed ROBINS-I scoring to evaluate the risk of bias in the included retrospective studies [33] ([Table 2]). The overall risk of bias of the retrospective studies was low to moderate in four studies, but one study showed a serious risk of bias, mainly due to missing data. Because of the small number of included studies, no testing for publication bias for the primary outcome was performed as recommended by the Cochrane Collaboration.
|
Study [ref.] |
Study type |
Pre-intervention |
At intervention |
Post-intervention |
Overall |
||||
|
Confounding |
Selection |
Classification of intervention |
Deviation from intervention |
Missing data |
Measurement of outcomes |
Selection of reported results |
|||
|
Brangewitz et al. [38] |
Retrospective |
2 |
2 |
1 |
2 |
1 |
1 |
1 |
2 |
|
Schniewind et al. [41] |
Retrospective |
3 |
2 |
1 |
1 |
3 |
3 |
2 |
3 |
|
Mennigen et al. [40] |
Retrospective |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Hwang et al. [39] |
Retrospective |
1 |
1 |
1 |
1 |
2 |
1 |
2 |
2 |
|
Berith et al. [31] |
Retrospective |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
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Outcomes
Patient outcomes are summarized in [Table 3]. All studies reported results on the duration of hospitalization. The number of stents, treatment duration, closure, and in-hospital mortality rate were reported in four trials. Three studies reported short-term or major complications, and two studies reported on post-therapeutic stricture and intensive care unit (ICU) duration.
|
Study, initial treatment method [ref.] |
Patients, n |
Number of stents/sponges, median (range) |
Treatment duration, median (range), days |
Tracheal injuries, n (%) |
Stricture, n (%) |
Successful closure rate, n (%) |
Time in ICU, mean (SD) or median (range), days |
Hospitalization, mean (SD) or median (range), days |
In-hospital mortality, n (%) |
|
Brangewitz 2013 [38] |
|||||||||
|
32 |
7 (5–28) |
23 (9–86) |
1 (3) |
3 (9) |
27 (84) |
– |
Mean 48.5 (21–122) |
5 (16) |
|
39 |
3 (2–6) |
33 (9–132) |
0 (0) |
11 (28) |
21 (54) |
– |
Mean 41 (2–93) |
11 (28) |
|
Schniewind 2013 [41] |
|||||||||
|
17 |
– |
– |
– |
– |
– |
26 (SD 19) |
57 (SD 30) |
2 (12) |
|
12 |
– |
– |
– |
– |
– |
38 (SD 32) |
62 (SD 39) |
5 (42) |
|
Mennigen 2015 [40] |
|||||||||
|
15 |
6.5 (1–18) |
26.5 (3–75) |
– |
– |
14 (93) |
– |
58 (23–106) |
1 (7) |
|
30 |
1 (1–6) |
36 (1–156) |
– |
– |
19 (63) |
– |
53 (13–195 |
8 (27) |
|
Hwang 2016 [39] |
|||||||||
|
7 |
4.3 (2–10) |
27 (2–84) |
– |
– |
7 (100) |
– |
37.1 (13–128) |
– |
|
11 |
1.6 (1–4) |
19.5 (5–21) |
– |
– |
7 (64) |
– |
87.3 (17–366) |
– |
|
Berlth 2018 [31] |
|||||||||
|
34 |
3 (1–9) |
12 (3–58) |
0 (0) |
1 (3) |
24 (71) |
6 (0–60) |
37 (19–118) |
3 (9) |
|
77 |
1 (1–3) |
27 (1–152) |
5 (6) |
5 (7) |
49 (64) |
9 (0–295) |
38 (13–296) |
11 (14) |
ICU, intensive care unit; EVT, endoscopic vacuum therapy; SEMS, self-expandable metal stent.
* Percentages relate to the total number of patients in each initial treatment group per study.
EVT was significantly associated with a higher rate of leak closure compared with stenting (OR 3.14, 95 %CI 1.23 to 7.98) ([Fig. 3]).
The number of endoscopic device changes was significantly more frequent in the EVT group than in the SEMS group, with an estimated pooled mean difference of 3.09 (95 %CI 1.54 to 4.64) ([Fig. 4 a]). The duration of treatment was generally shorter for patients treated by EVT, with the exception of one study that showed a shorter treatment time for the SEMS group. The estimated pooled mean difference (–11.90 days) was nevertheless statistically significant (95 %CI –18.59 to –5.21) ([Fig. 4 b]).
The duration of overall hospitalization was comparable between the two groups, with an estimated pooled median difference of 2.81 days (95 %CI –6.20 to 11.82) ([Fig. 4 c]). Data on the duration of ICU stay were extractable in only two studies, with varying measures of central tendency making a meta-analysis unfeasible.
Short-term and major complications failed to show significant differences (OR 0.69, 95 %CI 0.23 to 2.10; and OR 0.37, 95 %CI 0.11 to 1.24, respectively), even though major complications showed a tendency in favor of EVT ([Fig. 5a ,b]).
In-hospital mortality was significantly elevated in the group of patients treated with SEMS (OR 0.39, 95 %CI 0.18 to 0.83) ([Fig. 5 c]).
None of the studies reported data on long-term survival, time to resume oral nutrition after anastomotic leakage, quality of life or treatment costs.
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Discussion
Anastomotic leakage is one of the major complications that makes esophageal surgery challenging, even for experienced surgeons. Together with pulmonary complications, leakage is the main factor responsible for increasing postoperative mortality and prolonging hospital stay [42] [43] [44]. The actual therapeutic gold standard of postoperative esophageal leakage is the placement of SEMS [22], although promising results have also been published with EVT [45]. Whereas many studies can be found in the literature indicating the effectiveness of these techniques, prospective studies between the two treatments are still lacking. The presented systematic literature search identified five retrospective comparative studies with 274 patients in total (range 18–111, median 45 patients) that assessed the two different endoscopic therapies [31] [38] [39] [40] [41].
Our meta-analysis showed that EVT was associated with a higher rate of leak closure compared with SEMS placement. One important problem that led to limited comparability was the variable or absent (in most studies) definition of healing or leak closure, commonly described as the resolution of leakage-related symptoms and endoscopic or radiologic controls showing closure.
Analysis of the data on treatment duration showed that treatment with EVT was shorter compared with SEMS placement. It must be pointed out that the stents usually remain, in the case of successful sealing, for 4–6 weeks until a follow-up endoscopy with stent removal or stent change is performed. In contrast to this, EVT is repeated every 3–5 days until closure can be seen. Accordingly, the exact time point of leak closure is, in the case of SEMS therapy, usually not known, so this comparison might not be appropriate. A more adequate outcome parameter to measure the success of therapy might be the resolution of leakage-associated symptoms, the absence of further therapeutic interventions or the start of oral nutrition. Unfortunately, none of the studies presented these data. In concordance with this hypothesis, the comparison of hospitalization time failed to show a significant difference between the two treatments.
It is well known that both of these therapies have their typical complications such as hemorrhage, perforation, dislocation etc., but major complications seem to be quite rare and were not significantly different, suggesting that these are mainly related to the leak itself rather than the type of treatment. In particular, the negative pressure of EVT was not associated with the onset of bronchoesophageal fistula (two cases in the SEMS group and one case in the EVT group) [46].
One of the most important confounding factors in our analysis was the heterogeneity of the patients. As pointed out by Berlth et al., the complexity of the case (in terms of the circumferential extent of the leak) necessarily affects the outcome of the treatment [31]. As EVT is a relatively new technique, it could be assumed that the first experiences of the studies we included in our analysis were performed in cases in which a favorable outcome was expected, thus influencing the results. Although hypothetical, this might have resulted in a lower in-hospital mortality rate for EVT compared with SEMS.
Moreover, patients developing an esophageal leak present both different grades of leak and different comorbidities, which influence the outcome of treatment. In addition, whereas the SEMS procedure is quite standardized and reproducible, there are many variables associated with EVT that may be different between institutions, such as magnitude of negative pressure, extra- and intraluminal placement, and the time interval between sponge changes. Of the studies we included in our analysis, Schniewind et al. used a negative pressure of 70–80 mmHg, with different intervals between one change of the sponge and the other [41]. The other studies all reported using a negative pressure of 125 mmHg, but the intervals for sponge change ranged from 3 to 7 days [31] [38] [39] [40].
In our analysis, EVT was associated with a higher number of endoscopic device changes. On the one hand, this means more periprocedural stress for patients with the risks of recurrent sedation; on the other hand, this treatment requirement offers the possibility of performing endoscopic lavage and debridement with every change, which has been shown to reduce pleural inflammation and leakage-associated mortality [47]. Another important aspect for the comparison that has to be kept in mind is the economic aspect: owing to the higher number of endoscopies performed for EVT, the cost of this treatment modality is twice that of SEMS treatment [48]. None of the included studies presented data regarding the cost of treatment, which is an important factor in times of limited financial resources.
A recently published meta-analysis by Rausa et al. showed a significantly higher success rate for ETV in healing esophageal leaks, a lower incidence of major complication, and a lower in-hospital mortality rate compared with SEMS [49]. However, the statistical analysis was performed in a significantly smaller cohort of patients, as the data published by Berlth et al. [31], who reported on their experience with 111 patients, were not included. The Berlth study included the largest number of patients to date. Moreover, and in contrast to the other studies, it included only patients who underwent highly standardized upper gastrointestinal surgery for malignancies and also classified the leaks in each treatment group, with a consequent limitation of confounding factors.
The results of the current review should be interpreted carefully, taking into account the risk of bias in the included primary studies. Important methodological weaknesses were identified in some of the studies. The risk of bias was difficult to assess in some studies because of a lack of information in the study reports about the methodology and/or follow-up. As characterized by retrospective studies, no blinding of outcome assessment was performed. A reporting or publication bias cannot be precluded, as the comparison of medical products might be associated with commercial interests and nonsignificant results might affect the publication acceptance.
In conclusion, EVT appeared to have a significantly higher success rate in healing esophageal leaks, a shorter duration of treatment, and a lower in-hospital mortality rate compared with SEMS. No difference in length of hospital stay was calculated. The type of treatment did not seem to affect the incidence of major or short-term complications. However, owing to the limitations of the underlying trials, a clear recommendation without restrictions cannot be made for the treatment of esophageal anastomotic leakage. We highly recommend more robust prospective randomized comparative trials with standardized treatment and outcome parameters to further evaluate these two treatments. Therefore, prospective investigations or multicenter registries with standardized treatment algorithms should be performed to further investigate the promising results of EVT.
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Competing interests
The authors declare that they have no conflicts of interest.
Acknowledgments
We would like to thank Klaus-Dieter Papke, scientific librarian, for his assistance in conducting the systematic search of the literature.
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- 39 Hwang JJ, Jeong YS, Park YS. et al. Comparison of endoscopic vacuum therapy and endoscopic stent implantation with self-expandable metal stent in treating postsurgical gastroesophageal leakage. Medicine (Baltimore) 2016; 95: e3416
- 40 Mennigen R, Harting C, Lindner K. et al. Comparison of endoscopic vacuum therapy versus stent for anastomotic leak after esophagectomy. J Gastrointest Surg 2015; 19: 1229-1235
- 41 Schniewind B, Schafmayer C, Voehrs G. et al. Endoscopic endoluminal vacuum therapy is superior to other regimens in managing anastomotic leakage after esophagectomy: a comparative retrospective study. Surg Endosc 2013; 27: 3883-3890
- 42 Goense L, Meziani J, Ruurda JP. et al. Impact of postoperative complications on outcomes after oesophagectomy for cancer. Br J Surg 2019; 106: 111-119
- 43 Booka E, Takeuchi H, Suda K. et al. Meta-analysis of the impact of postoperative complications on survival after oesophagectomy for cancer. BJS Open 2018; 2: 276-284
- 44 Low DE, Alderson D, Cecconello I. et al. International consensus on standardization of data collection for complications associated with esophagectomy: Esophagectomy Complications Consensus Group (ECCG). Ann Surg 2015; 262: 286-294
- 45 Kahler G. Anastomotic leakage after upper gastrointestinal surgery: endoscopic treatment. Visc Med 2017; 33: 202-206
- 46 Lambertz R, Holscher AH, Bludau M. et al. Management of tracheo- or bronchoesophageal fistula after Ivor-Lewis esophagectomy. World J Surg 2016; 40: 1680-1687
- 47 Weidenhagen R, Hartl WH, Gruetzner KU. et al. Anastomotic leakage after esophageal resection: new treatment options by endoluminal vacuum therapy. Ann Thorac Surg 2010; 90: 1674-1681
- 48 Baltin C, Kron F, Urbanski A. et al. The economic burden of endoscopic treatment for anastomotic leaks following oncological Ivor Lewis esophagectomy. PLoS One 2019; 14: e0221406
- 49 Rausa E, Asti E, Aiolfi A. et al. Comparison of endoscopic vacuum therapy versus endoscopic stenting for esophageal leaks: systematic review and meta-analysis. Dis Esophagus 2018; 31
Corresponding author
Publication History
Received: 26 September 2019
Accepted: 10 March 2020
Article published online:
21 April 2020
© Georg Thieme Verlag KG
Stuttgart · New York
-
References
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- 45 Kahler G. Anastomotic leakage after upper gastrointestinal surgery: endoscopic treatment. Visc Med 2017; 33: 202-206
- 46 Lambertz R, Holscher AH, Bludau M. et al. Management of tracheo- or bronchoesophageal fistula after Ivor-Lewis esophagectomy. World J Surg 2016; 40: 1680-1687
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