Endoluminal vacuum-assisted closure therapy for oesophageal fistulas at a single vietnamese center

Introduction

Perforation or oesophageal fistula results from the continuous loss of oesophageal walls and leads to communication between the lumen of the esophagus and extraesophageal organs (1,2). They can occur spontaneously, as in patients with Boerhaave syndrome, either as a complication of surgery (after oesophagectomy) or an accident during a laparoscopic procedure. Fistula and perforation of the esophagus have caused significant life-threatening complications, with a mortality rate of 13.2% (3,4). Treatment strategies include nonsurgical techniques, such as thoracic drainage, gastric drainage, antibiotics, and intravenous nutrition; endoscopic techniques, such as stenting and the use of forceps; endoscopic aspiration in situ, and open surgery. Although surgery is considered the standard treatment, some studies have associated less invasive options with improved outcomes (5,6). Endoluminal vacuum-assisted closure (E-Vac) was first successfully used in 2008 by Weidenhagen and colleagues to close the anastomosis fistula after rectal resection and sigmoid resection (7,8). That same year, Wedemeyer and colleagues used E-Vac to treat connecting anastomosis fistulas in two patients who had undergone oesophagectomy (9). Since then, the use of E-Vac to treat postoperative oesophageal fistulas in patients with upper gastrointestinal (GI) cancer has been increasing (10). However, there are no specific recommendations regarding applying E-Vac to treat oesophageal leakage (11-13).

This study aimed to evaluate the indications, clinical success rates, and complications of this promising minimally invasive technique. These were the first E-Vac surgeries ever performed at our facility. Our report on this technique’s early results and challenges will provide colleagues worldwide with invaluable insight. This research can be useful for education and clinical practice purposes. We present this article in accordance with the STROBE reporting checklist (available at https://ales.amegroups.com/article/view/10.21037/ales-24-32/rc).

Methods

We performed a retrospective observational study of all patients who underwent surgery to treat oesophageal leakage and perforation at Vietduc University Hospital. One GI surgeon with over ten years of experience performed all the laparoscopic oesophagectomies.

Inclusion criteria were patients who experienced spontaneous oesophageal perforation due to endoscopic intervention or anastomosis fistula after esophagectomy and mild or moderate infection.

Exclusion criteria were patients without severe infections, septic shock, or respiratory failure. In addition, patients underwent other routine tests, such as kidney and liver function evaluations.

Data collection

Routine preoperative evaluations, including blood tests, abdominal and chest computed tomography (CT) scans, upper GI endoscopy, were performed to define the size and location of the fistula clearly. The demographics and preoperative data included age, gender, area of puncture or fistula, puncture size, lesion classification, number of sponge replacements, duration of treatment, success rate, and complications of oral stenosis after treatment.

E-Vac procedure

The patient underwent a comprehensive physical examination involving a systemic assessment of the degree of infection, malnutrition, and respiratory failure. Computed tomography of the chest or abdomen was performed to evaluate the condition of the abscess around the puncture site (Figure 1). An endoscopy was performed to assess the perforation condition, including the location, size, and nature of the puncture (Figure 2).

Figure 1 Chest computed tomography. (A) Axial slice and (B) horizontal slice with esophageal perforation lesion as a white arrowhead; right pleural effusion and posterior mediastinal fluid collection. The thin arrow in (A) represents the sign of contrast material escaping through the site of esophageal perforation.

Figure 2 Endoscopic image of the digestive tract. Gastric tube perforation in a male patient, 56 years old, after esophagectomy (T2N0M0) due to esophageal cancer on day 9. (A) Esophageal tube perforation (white arrow) and (B) endoscopic sponge placement technique (yellow arrow).

The principle of E-Vac is to reduce the number of bacteria in the foci of infection, reduce the extent of surgery, and reduce tissue oedema. The suction pressure is continuously maintained at approximately 120 mmHg for 5 to 7 days (Figure 3); after that, the patient undergoes endoscopy to re-evaluate the suction system, reassess the lesion, and usually replace the sponge pad (Figure 4). The procedure can be performed in the operating room, endoscopy suite, or at the bedside. For patients with upper GI defects, anaesthesia with endotracheal intubation is recommended for safe airway management during the passage of the sponge. However, during exchanges, deep sedation may be preferred for certain patients. Deep sedation is likely safe for patients with lower GI tract defects depending on other clinical factors. Once the patient is adequately sedated, endoscopic evaluation is required to identify and characterize the wall defect and to evaluate the contaminated cavity. Once adequately evaluated, endoscopic irrigation and debridement are recommended (Figure 5). To choose the correct sponge size, the cavity is meticulously evaluated (with or without fluoroscopy); estimation can be based on the size of the endoscope or the endoscopist’s observation. Then, the endoscope is removed, and the sponge system is prepared.

Figure 3 Endoluminal vacuum-assisted closure therapy for oesophageal leaks and fistulas. (A) Endoscopic exploration; (B,C) sponge placement via overtube; (D) channeling the tube through the nose; (E,F) starting suction via vacuum pump. EVT, endoluminal vacuum-assisted therapy.

Figure 4 Prepare to place sponges and continuous negative pressure suction drains.

Figure 5 Endoscopy of the digestive tract after treatment in the (A) first week and (B) second week.

The endoscopic procedure for placing negative pressure suction at the site of closure of the oesophageal fistula consists of the following steps: as soon as the location of the leak is identified under endoscopy, the pump is used to remove fluid from the cavity, and the gastric catheter is inserted through the nostril and removed through the mouth, after which a sponge with an opening is attached to the tip of the gastric catheter. The gastric catheter size was 16 Fr. The central part of the sponge is placed precisely at the site of the endoscopic leak. This catheter is connected to a vacuum machine that produces a continuous negative pressure of 75 mmHg. The tube is marked and taped to the nostrils to monitor and prevent dislocation from the site. During therapy, the sponge is inspected every 6 hours to detect leaks and dislocations from the site. The sponge is removed after 4 to 6 days under gastroscopy. Once removed, the fistula and gastric catheter are endoscopically evaluated to check for leakage or ischaemia. Endoscopy, radiography with contrast, or computed tomography is performed again to assess the presence or absence of late leakage, and meticulous evaluation of the cavity (with or without fluoroscopy) is performed to choose the correct sponge size; estimation of the sponge size can be based on the size of the endoscope or the endoscopist’s observation according to the following clinical course (Figure 6).

Figure 6 Endoscopy of the digestive tract after treatment in the third week.

Postoperative follow-up

Patients are followed up at 1 month, 3 months, 6 months, 1 year, 2 years, and 5 years. The evaluation criteria include systemic condition, degree of choking, endoscopy of the esophagus, and chest computed tomography. For patients with oesophageal cancer, we plan to administer chemotherapy and radiation treatment after surgery.

Definitions

Diagnosis of esophageal perforation, perforation location, perforation size based on esophageal endoscopy and chest computed tomography. In addition, Boerhaave syndrome is diagnosed based on signs of severe cough, left chest pain, and shortness of breath combined with signs of perforation. Foreign body causing esophageal perforation is identified during endoscopy; inflammatory esophageal perforation: signs of perforation + anatomical disease are chronic inflammation. Based on computed tomography, the perforation site is located in the upper, middle, and lower of the esophagus when comparing the perforation with the thoracic aortic, pulmonary vein, and gastric cardia.

Statistical analyses

Categorical data are summarized as the number and percentage of patients. The mean and standard deviation (SD) are used for continuous variables. All the statistical analyses were performed using SPSS 20.0 software (SPSS Inc., Chicago, IL, USA). All patients were informed about the procedure, risks, and advantages of the E-Vac procedure.

Ethical statement

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by The Institutional Ethics Committee of Vietduc University Hospital (No. 2023.TH09) on September 15, 2023. Individual consent for this retrospective analysis was waived.

Results

Between June 2021 and February 2023, 11 patients were diagnosed with oesophageal fistula, and perforations were endoscopically evaluated prior to negative pressure aspiration at the site of oesophageal fistula closure at Viet Duc Hospital. The mean age of the patients in the study group was 59.1 (range, 41–70) years. The male/female ratio was 10/1. The rates of post-oesophagectomy perforation, Boerhaave syndrome, foreign-body oesophageal perforation, and inflammatory perforation were 18.2%, 36.4%, 27.3%, and 18.2%, respectively. The percentages of perforations in the lower 1/3, middle 1/3, and upper 1/3 were 54.5%, 27.3%, and 18.2%, respectively. The percentages of individuals with perforations ≤2 and >2 cm in size were 72.7% and 27.3%, respectively (Table 1).

The number of sponges used per patient was 5.1 (range, 3–9). The mean sponge replacement time was 4.5±0.5 (range, 4–5) days. The mean length of hospital stay was 25.6±9.4 (range, 14–45) days. Post-treatment success and failure outcomes were 81.8% and 18.2%, respectively. The complication and mortality rates were 9.1% and 9.1%, respectively (Table 2).

According to documents in the medical literature, E-Vac is an effective treatment method for perforated esophageal injuries with an overall success rate of 70–100%; treatment time ranges from 11–36 days (Table 3).

Discussion

E-Vac represents a clinical endoscopic evolution of vacuum-assisted closure therapy, a well-established treatment for open wounds (14,16). No standardized indications for its use have been established since it is still a relatively new technique (15). All patients with acute or chronic GI defects were candidates for E-Vac. Endoscopic evaluation is always required before treatment to identify the wall defect, characterize the leak or fistula tract, and evaluate the contaminated cavity. More significant defects, including perforations, leaks, and fistulas, which are typically associated with fluid collection, are the most common indications for E-Vac, and studies have shown high rates of healing associated with this technique. When a minor defect is associated with a contaminated cavity, dilation of the defect to access the cavity is needed to place the sponge extraluminally. Additionally, minor defects less than 10 mm in length without an associated cavity can be managed with intraluminal placement of the sponge (17).

E-Vac is suitable for oesophageal, gastric, small bowel, biliopancreatic, and colorectal defects throughout the GI tract. According to established data, the most common indications are defects in the oesophagus (perforations, leaks, and fistulas after anastomoses), stomach (mainly after bariatric surgery), and colorectal areas (anastomotic leaks and fistulas). Additionally, recent data on the early use of E-Vac in patients with anastomotic ischemia following oesophagectomy have shown favourable results. E-Vac is an effective treatment for ischaemia of the blind end of the jejunal loop after Roux-en-Y gastrectomy (17).

The application of E-Vac is widely indicated for cases of oesophageal leakage due to various causes; the purpose of this therapy is to suck fluid out of the wound to reduce the bacterial load in the wound and stimulate the tissues to heal to produce healthy granular tissue (18). Newton’s author compiled many studies showing that mouth leakage after surgery is the most common indication. The sponge was replaced for approximately 3–4 days until the cavity was small enough to heal (18,19). Bodo Schniewind stopped therapy when the diameter of the wound cavity was less than 2 cm (20). In our case series, the mean replacement time was 4.5 days and the healing time was 25.6 days. The healing time varied and depended on patient characteristics and lesion status. However, the mean was 18 days, and the number of sponge changes per patient was 5.4. The success rate in our study was similar to that reported by other authors (81.8%) (18). In one study comparing metal or plastic stents with E-Vac for leakage treatment in the thoracic junction, the overall closure rate in the E-Vac group (84.4%) was significantly higher than that in the stent group (53.8%) (21). The mortality rate in our study was 9.1%, and the overall mortality rate associated with E-Vac (0–26%) was lower than the mortality rate associated with surgery (>40%) (18). In addition to oral stenosis, which can be easily corrected with laparoscopic angioplasty (1 patient in our study), unpleasant sensations associated with gastric catheters and discomfort caused by repeated sponge replacement procedures, the complication of E-Vac that raises the most concern is massive bleeding. However, light bleeding can sometimes occur during sponge removal due to granular tissue entering the E-Vac sponge; heavy bleeding may result from the development of a fistula between the cavity and the aorta (or aortic branches), as well as after the formation and rupture of pseudoaneurysms involving blood vessels or heart chambers. The weakening, erosion, leakage, and pseudobulging of such large vascular structures are due to the ongoing inflammatory process and erosion of these structures; changing sponges more frequently can reduce the risk of this serious complication.

Our study has certain limitations. Sample size is the biggest problem with this study. Additionally, the study is limited because it only includes esophageal defects. We will continue to pay attention to this issue in the future.

Conclusions

E-Vac is a novel alternative for treating postoperative oral fistula and oesophageal perforation caused by other conditions. Randomized clinical trials comparing E-Vac with surgery and other minimally invasive techniques are needed to determine its indications and effectiveness.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://ales.amegroups.com/article/view/10.21037/ales-24-32/rc

Data Sharing Statement: Available at https://ales.amegroups.com/article/view/10.21037/ales-24-32/dss

Peer Review File: Available at https://ales.amegroups.com/article/view/10.21037/ales-24-32/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://ales.amegroups.com/article/view/10.21037/ales-24-32/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by The Institutional Ethics Committee of Vietduc University Hospital (No. 2023.TH09) on September 15, 2023. Individual consent for this retrospective analysis was waived.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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