The Role of Open-Pore Film Drainage Systems in Endoscopic Vacuum Therapy: Current Status and Review of the Literature

Abstract

Background

Endoscopic vacuum therapy (EVT) is an increasingly popular endoscopic technique used for the treatment of wall defects in the gastrointestinal tract. Open-pore film drainage (OFD) systems are a new addition to the armamentarium of EVT and have shown encouraging results in a wide spectrum of applications. The aim of this review is to summarize the current literature on the applications of OFD systems in the gastrointestinal tract.

Summary

Open-pore film drainage (OFD) systems have been used for the treatment of several defects of the gastrointestinal tract. The small size and easy placement of these devices make them very useful, particularly for the treatment of defects that are small in size or difficult to reach. OFDs have been successfully used for both perforations and anastomotic leaks in various locations, with most reports focusing on the treatment of duodenal defects, although successful applications in the esophagus, stomach, and colon have also been reported. Lately, the role of OFDs in preemptive EVT has also been explored.

Key Messages

OFD systems are easy to use, particularly for small defects and challenging localizations. The current literature, consisting mainly of small case series and case reports, shows encouraging results, but further prospective studies are needed to explore and verify the indications and technical aspects of this innovative method.

Introduction

Endoscopic vacuum therapy (EVT) is a minimally invasive and effective technique for the treatment of wall defects in the gastrointestinal tract. It was initially described in 2003 for the treatment of anastomotic leaks in the rectum, and in 2008 the first reports of its use in the upper gastrointestinal tract were published [1–3]. The technique as described in these initial reports consisted of the endoscopic placement of a polyurethane sponge attached to a flexible, plastic drain tube through the defect of the gastrointestinal wall and into the adjacent extraluminal cavity (intracavitary EVT), which was then connected to an external negative pressure unit. Later reports described an alternative placement of the sponge inside the lumen, in front of the defect (intraluminal EVT) [4, 5]. Open-pore film drainage (OFD) was introduced in 2015 as an alternative to the polyurethane sponge in an attempt to facilitate EVT in difficult and distant locations and enable intracavitary EVT through smaller defects [6, 7]. This narrative review summarizes the current literature on the use of OFD for the treatment of gastrointestinal wall defects, focusing on its technical aspects and clinical applications.

Basic Principles of EVT and Limitations of the Polyurethane Sponge

The effects of negative pressure on wound healing were initially described by plastic surgeons and used for the treatment of secondary healing wounds [8]. It has been shown that the application of negative pressure improves the drainage of toxic wound secretions, increases vascularization, facilitates the formation of granular tissue, and causes macrodeformation and eventually shrinking of the wound [8–10]. To achieve this, a polyurethane sponge is placed in the secondary healing wound and sealed with an airtight foil. The system is then connected to a suction pump with a plastic tube [8]. When EVT was initially introduced for the treatment of gastrointestinal defects, the same polyurethane sponge was attached at the end of a thin drain tube and then endoscopically placed in front of or through the defect. Both in intracavitary and intraluminal EVT, the negative pressure applied to the sponge would cause the cavity or lumen to collapse around it and seal the system without the need for an airtight seal [1, 4, 11]. The sponge has to be changed regularly, usually 2–3 times per week, until the defect is completely closed or the remaining cavity is small, covered with healthy granular tissue, and has adequate drainage to the lumen [11–15]. EVT has shown very good results when used for the treatment of a wide range of defects in the entire gastrointestinal tract, with success rates sometimes exceeding those of surgical treatment and with considerably less morbidity and mortality, leading some authors to describe it as the “new gold standard” in the treatment of those patients [16].

In the initial reports, the sponge-drain tube system was handmade, usually using a macroporus, low-density sponge made for external vacuum therapy and a drain tube or nasogastric tube; it was then inserted with the help of an endoscopic forceps under direct endoscopic view [1, 5]. This technique, also known as the “piggyback method,” is cheap, applicable to a wide range of defects since the device can be modeled accordingly, and is still being used in many centers [12, 17]. However, parallel insertion of the endoscope and sponge can be technically challenging, especially in narrow areas like the esophagus, and can cause friction and potentially injuries. Apart from that, the endoscopic view may be obscured by the bulky sponge, thus making accurate insertion through the defect more difficult. Therefore, an alternative technique was developed, according to which an overtube is inserted under endoscopic view with its tip at the area where the sponge has to be deployed; the endoscope is then removed, and the sponge is inserted through the overtube with the help of a pusher. Currently, there is one commercially available EVT system based on this principle (EndoSponge/EsoSponge, B. Braun Melsungen AG, Melsungen, Germany), which has been successfully used in several published studies [5, 18, 19]. The use of the overtube during insertion of the sponge protects delicate structures, like the pharynx, the upper esophageal sphincter, and the esophageal wall, and its tip can be placed through the defect, allowing easy and direct insertion of the sponge into the cavity [20]. Nevertheless, the overtube may limit the maneuverability of the endoscope, and the defect has to be large enough to allow for insertion of the overtube in case of intracavitary EVT.

Special caution is required in the case of intraluminal EVT since polyurethane sponge-based systems can cause a complete occlusion of the lumen. In these cases, an additional or integrated feeding tube is required to allow for enteral nutrition [20, 21]. A further disadvantage of the sponge, especially relevant in intracavitary EVT adjacent to delicate structures, is the tissue ingrowth through the pores of the sponge, causing a strong adherence to the wound tissue. This can make its removal challenging, especially after a longer interval and in already debrided cavities, and there are some rare reports of serious and potentially fatal bleeding during sponge removal [12, 18, 20, 22–24].

Technical Aspects and Advantages of OFD

The concept of open-pore film drainage was introduced by Gunnar Loske et al. [6, 25] as an alternative to the common sponge used for EVT in the upper gastrointestinal tract. At the moment, there is no commercially available OFD system, and it therefore has to be prepared individually before every application. To prepare the OFD, a drainage tube or nasogastric tube and a very thin open-pore, double-layered drainage film (Suprasorb CNP, Drainage Film, Lohmann & Rauscher International GmbH & Co. KG, Rengsdorf, Germany) are used. The film, initially developed for abdominal negative pressure therapy, consists of two perforated membranes with a small interspace, which does not collapse when vacuum is applied but instead transmits the negative pressure along its entire surface. To date, only one commercially available film has been used for this purpose in published reports. A wide variety of tubes can be used, including nasogastric tubes, dual-lumen devices with integrated feeding tubes, and surgical drains of different sizes, and the choice depends on the size, geometry, and localization of the defect. The film is tightly wrapped around the distal, perforated end of the tube and fixed in place with a suture [7]. An additional loop can be formed with the suture at the distal tip of the tube, which can be grasped with the endoscopic forceps to facilitate its placement (shown in Fig. 1). For applications in the upper gastrointestinal tract, the OFD is inserted through the nostrils like a normal nasogastric tube, and the distal part is placed in the area of the defect under endoscopic control. In the case of intracavitary EVT, the tip of the drain or the loop can be grasped with an endoscopic forceps and inserted through the defect in the adjacent cavity. A standard negative pressure pump is connected to the external end of the tube, and the negative pressure is evenly distributed on the entire surface of the film-wrapped, distal part [7]. The pressure settings are similar to those of any other type of EVT and depend on the localization and type of the defect. Similarly to polyurethane sponge-based systems, the pores of the OFD might be occluded by secretions or debris, thus reducing its ability to evenly apply the negative pressure; therefore, regular system changes 1–2 times per week are recommended. The open-pore film seems to adhere less to the tissue in comparison to polyurethane sponges, thus allowing for prolonged system change intervals; however, the data available at the moment are not sufficient for an evidence-based recommendation.

Fig. 1.

OFD materials. a Materials necessary for the preparation of the OFD: nasogastric tube, open-pore film, needle holder, scissors, suture. b–d Step-by-step preparation of the OFD by wrapping the open-pore film around the tip of the nasogastric tube and stitching it in place with the suture.

If the OFD is placed intraluminally, a double-lumen tube consisting of a long, distal feeding tube and a shorter and wider gastric decompression tube can be used instead. The open-pore film is wrapped and fixed around the distal, perforated part of the gastric decompression tube. This part is placed in front of the defect, and only the gastric decompression tube is connected to the negative pressure pump, while the distal part is placed deep in the duodenum or jejunum to facilitate simultaneous enteral feeding without the need for an additional feeding tube [26, 27].

Recently, an alternative pull-through technique was described for the placement of OFDs in extraluminal spaces previously treated with percutaneous drains. This report also highlights the use of OFDs after initial sponge-EVT as the defect decreases in size, in the form of a step-down approach [27, 28].

The main advantage of OFD is its small size in comparison to bulky polyurethane sponges, which makes its placement in distal locations, such as the duodenum, or through small defects easier [6, 25]. If placed intracavitary, the homogenous application of the negative pressure induces the formation of granular tissue, but the smooth surface of the film prevents tissue ingrowth and adherence of the device to the wall, thus facilitating its removal and potentially reducing the risk of bleeding complications [29]. Therefore, unlike the sponge-based systems, the OFD may be placed in close proximity to vulnerable organs, such as the intestine or pleura. Because of this minimal tissue adherence, the OFD might be left in place for longer intervals of up to 8 days, thus reducing the number of endoscopic procedures necessary [30].

Clinical Applications and Outcomes of OFD

The placement of polyurethane sponge drains in the duodenum is particularly challenging. The passage of the pylorus with the sponge parallel to the endoscope with the “piggyback method” can be technically demanding, and the commercially available overtubes are too short and cannot reach the duodenum. Therefore, the first and probably most common use of OFDs is in the treatment of duodenal defects, as shown in Figure 2 [25, 28, 31–33]. The OFD can be easily forwarded into the stomach and then guided through the pylorus with an endoscopic forceps, like a standard enteral feeding tube. The feasibility and efficacy of this treatment have been demonstrated in small case series for various duodenal defects, including perforated duodenal diverticula, iatrogenic perforations after ERCP or endoscopic mucosal resection, and anastomotic leaks, and it has been a game changer for the minimally invasive treatment of these challenging cases [25, 31–34]. A recent experimental study also showed the high drainage capacity of the OFD, a feature particularly important in the duodenum, where the presence of bile and pancreatic secretions can have a negative effect on tissue healing [35].

Fig. 2.

OFD application in the duodenum. a Iatrogenic perforation in the descending part of the duodenum during endoscopic retrograde cholangiopancreatography (ERCP), opposite from the ampulla of Vater. b Placement of the OFT in the duodenum with the grasping forceps. c Complete healing of the defect.

In addition to the duodenal applications, the small diameter and easy placement of the OFD as well as the possibility of simultaneous enteral feeding when using a double-lumen tube can be useful for the treatment of various defects in the upper gastrointestinal tract, especially for small defects and locations that are difficult to reach. In the last 8 years, OFDs have been successfully used for the treatment for spontaneous and iatrogenic esophageal perforations and anastomotic leaks after oncologic and bariatric surgery (shown in Fig. 3) [6, 7, 21, 30, 36–38].

Fig. 3.

OFD application in the esophagus. a Anastomotic leak after Iwor-Lewis esophagectomy. b Intracavitary placement of the OFD. c OFD in situ during the second EVT cycled. d Healed anastomosis with complete obliteration of the cavity.

Reported applications in the lower gastrointestinal tract are scarcer. In 2019, Wallstabe et al. [39] reported the successful intracavitary EVT of an anastomotic leak after left hemicolectomy in a morbidly obese patient with the use of OFD. In the colon, and especially in the absence of a protective ostomy, intraluminal EVT is problematic because of the occlusion of the lumen and the risk of sponge dislocation, and an intracavitary regime is always preferable. The advantage of OFD in such cases is that it allows the intracavitary placement of the device even through very small defects, as shown in Figure 4. However, current evidence on OFD applications in the colon is weak, and further studies are necessary to pinpoint both the best indications and the technical aspects. In the case of fistulas, the thin drain can be passed through long and complex canals, especially with the use of a pull-through technique, and this method has been successfully used for the treatment of rectal, rectovaginal, and parastomal fistulas [40–44].

Fig. 4.

a OFD application in the colon. b, c Rectal stump leak with visible suture material and a fistula to the abdominal cavity. d OFD placed through the defect in the fistula.

Apart from its applications in the gastrointestinal tract, the small size and easy application of OFD also make it attractive for the treatment of similar defects in other areas. Loeck et al. [45] reported the use of OFDs in the treatment of various defects after head and neck surgery, whereas isolated reports describe its use for defects of the uterus and bladder [46, 47].

The Role of OFD in Preemptive EVT

Preemptive EVT is an emerging trend, focusing on the prevention of anastomotic leaks after esophageal surgery in high-risk patients. In 2017, Neumann et al. [48] suggested a scheduled endoscopic control of the anastomosis a few days after esophagectomy with initiation of EVT if signs of ischemia were present, even in the absence of an evident leak. Later studies started EVT intraoperatively after completion of the anastomosis and reported anastomotic leaks of 5–7.5%, which are at the lower end of the range usually reported, although still based on small case series [49, 50].

In 2017, Loske introduced the theory that acid, and especially bile reflux, is a major risk factor for anastomotic leaks after Iwor-Lewis esophagectomy and thus suggested the preemptive use of a double-lumen tube with a 25 cm-long OFD segment placed in the gastric conduit and a long enteral feeding tube placed deep in the duodenum. This device is easy to place intraoperatively, even without the use of an endoscope; it enables adequate drainage of the acid and bile reflux, thus protecting the anastomosis; and it allows simultaneous enteral feeding of the patient (shown in Fig. 5). The device was left in situ for 5 days, and then the anastomosis was controlled endoscopically. If signs of necrosis or ischemia were present, the treatment was continued [27]. The first published series of 24 cases of this “preemptive active reflux drainage (PARD)” showed encouraging results, with no reported anastomotic leaks [51].

Fig. 5.

Preemptive OFD application in the esophagus. a The proximal end of the OFD placed distal to the anastomosis. b The OFD extends through the entire gastric sleeve. c The distal end of the OFD placed directly proximal to the pylorus and the enteric feeding tube is advanced in the jejunum. (notice the green color of the OFD due to the biliary secretions absorbed).

Conclusions

OFD is a new and attractive alternative to the classic polyurethane sponges for EVT and can be used for various indications and localizations. The small size and easy placement of the device make it particularly useful for defects that are small or difficult to reach. A wide range of clinical applications have been described; however, they are mainly in case reports and small case series, so the currently available evidence is weak. Further prospective studies are necessary to compare OFD with other EVT devices and determine the most appropriate indications and patient groups for this treatment.

Conflicts of Interest Statement

Gunnar Loske is a consultant for Lohmann & Rauscher GmbH & Co. KG. Konstantinos Kouladouros and Dörte Wichmann have no conflicts of interest.

Funding Sources

There is no grant support and no internal or external funding for this article.

Author Contributions

All authors contributed equally to the review of the literature, the preparation, and the revision of the manuscript.

Funding Statement

There is no grant support and no internal or external funding for this article.