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Cost-effective modified endoscopic vacuum therapy for the treatment of gastrointestinal transmural defects: step-by-step process of manufacturing and its advantages

Open AccessPublished:September 04, 2021DOI:https://doi.org/10.1016/j.vgie.2021.08.002

      Video

      (mp4, (75.94 MB)

      Cost-effective modified endoscopic vacuum therapy for GI transmural defects. Step-by-step process of manufacturing and potential advantages.

      • 1.
        Cut half gauze to the ideal size to cover only the fenestrated portion of the nasogastric tube (NGT).
      • 2.
        Wrap the gauze around the fenestrated portion of the NGT. The assistance of another person is important in this process.
      • 3.
        Cut the antimicrobial incise drape to match the size of the fenestrated portion of the NGT. Note that the incise drape is a very strong adhesive; therefore, 3 people are usually required to assemble it properly.
      • 4.
        Next, the suture is used to fix the gauze and drape to the NGT. Perform fixation of the modified sponge in 3 places. The first knot is in the proximal portion, just below the last fenestra of the NGT, as a marker of where the vacuum system starts. The second knot is at the distal end, to avoid migration of the modified sponge. The third knot is in the middle of the modified sponge, which is essential to serve as a guide during endoscopic placement. For example, in cases of defects without collection in which the sponge will be placed in an intraluminal position, it is ideal to place the vacuum system in the middle of the defect; in cases of intracavitary placement, it will work as a guide to how much of the modified sponge will be inside the collection.
      • 5.
        Finally, use a needle to make innumerable punctures in the modified sponge system to obtain adequate aspiration. An 18G needle is recommended because, in addition to having an adequate diameter, it is very sharp, which facilitates perforation of the modified sponge system.
      • 6.
        After creation of the modified endoscopic vacuum therapy, the functionality test is performed. Turn on the wall suction system, connect the distal end of the NGT to the tube of the canister connected on the wall, and place the NGT inside a bowl with a liquid solution. The aspiration of a large amount of liquid indicates proper functioning of the modified endoscopic vacuum therapy system.
      • 7.
        The device is then ready to be positioned endoscopically in the patient. After proper positioning, connect the NGT to the suction tube to avoid migration of the device upon removal of the scope.
      • 8.
        In addition to the cost-effective device as described, in our practice we also use wall suction to reduce costs associated with the use of the vacuum machine.
      • 9.
        Use the antimicrobial incise drape to seal the connection between the NGT and the suction tube to avoid leakage within the connection.
      • 10.
        Last, owing to instability of the negative wall pressure, a 20F intravenous catheter is connected to the tube to maintain a negative pressure between –75 and –150 mmHg, as confirmed by laboratory studies performed by our group.

      Abbreviations:

      EVT (endoscopic vacuum therapy), NGT (nasogastric tube), SEMS (self-expandable metal stent)

      Background

      GI transmural defects may be classified into 3 distinct categories: perforations, leaks, and fistulas. Each represents a therapeutic challenge directly affecting morbidity, mortality, and quality of life and is associated with significant healthcare costs.
      • de Moura D.T.H.
      • Sachdev A.H.
      • Thompson C.C.
      Endoscopic full-thickness defects and closure techniques.
      ,
      • Bemelman W.A.
      • Baron T.H.
      Endoscopic management of transmural defects, including leaks, perforations, and fistulae.
      Endoscopic therapy has become the first-line therapy in most cases,
      • de Moura D.T.H.
      • de Moura B.F.B.H.
      • Manfredi M.A.
      • et al.
      Role of endoscopic vacuum therapy in the management of gastrointestinal transmural defects.
      ,
      • Rogalski P.
      • Swidnicka-Siergiejko A.
      • Wasielica-Berger J.
      • et al.
      Endoscopic management of leaks and fistulas after bariatric surgery: a systematic review and meta-analysis.
      with available treatment modalities that include closure techniques such as glues/tissue sealants, cap-mounted clips, and endoscopic suturing; cover techniques such as self-expandable metal stents (SEMSs) and cardiac septal defect occluder devices; and endoscopic draining approaches such as septotomy, endoscopic internal drainage with double-pigtail stents, and endoscopic vacuum therapy (EVT).
      • Baptista A.
      • Hourneaux De Moura D.T.
      • Jirapinyo P.
      • et al.
      Efficacy of the cardiac septal occluder in the treatment of post-bariatric surgery leaks and fistulas.
      • Donatelli G.
      • Spota A.
      • Cereatti F.
      • et al.
      Endoscopic internal drainage for the management of leak, fistula, and collection after sleeve gastrectomy: our experience in 617 consecutive patients.
      • Hourneaux de Moura D.T.
      • Jirapinyo P.
      • Hathorn K.E.
      • et al.
      Use of a cardiac septal occluder in the treatment of a chronic GI fistula: what should we know before off-label use in the GI tract?.
      • Haito-Chavez Y.
      • Kumbhari V.
      • Ngamruengphong S.
      • et al.
      Septotomy: an adjunct endoscopic treatment for post-sleeve gastrectomy fistulas.
      Unlike other endoscopic techniques, EVT has several mechanisms of action to promote healing, including microdeformation, macrodeformation, changes in perfusion, exudate control, and bacterial clearance.
      • de Moura D.T.H.
      • de Moura B.F.B.H.
      • Manfredi M.A.
      • et al.
      Role of endoscopic vacuum therapy in the management of gastrointestinal transmural defects.
      Current indications for EVT are broad, including acute, early, late, and chronic GI defects, such as esophageal, gastric, small-bowel, biliopancreatic, and colorectal defects. For these reasons, EVT has become the preferred technique for management of transmural defects, especially in Europe and Brazil.
      • de Moura D.T.H.
      • Brunaldi V.O.
      • Minata M.
      • et al.
      Endoscopic vacuum therapy for a large esophageal perforation after bariatric stent placement.
      • Loske G.
      • Müller C.T.
      Tips and tricks for endoscopic negative pressure therapy.
      • de Moura D.T.H.
      • do Monte Junior E.S.
      • Hathorn K.E.
      Modified endoscopic vacuum therapy in the management of a duodenal transmural defect.
      • Kuehn F.
      • Loske G.
      • Schiffmann L.
      • et al.
      Endoscopic vacuum therapy for various defects of the upper gastrointestinal tract.
      • de Moura D.T.H.
      • do Monte Junior E.S.
      • Hathorn K.E.
      • et al.
      The use of novel modified endoscopic vacuum therapies in the management of a transmural rectal wall defect.
      Polyurethane foam is traditionally used to perform EVT. However, some challenges have been reported, including difficulty with placement and removal, prolonged procedure times, need for multiple EVT system exchanges, and tissue ingrowth, which may increase the risk of bleeding. To overcome these limitations, the use of an open-pore film was recently reported, providing potential benefits over the polyurethane foam, such as easy placement and longer intervals between EVT systems exchanges.
      • Loske G.
      • Schorsch T.
      • Rucktaeschel F.
      • et al.
      Open-pore film drainage (OFD): a new multipurpose tool for endoscopic negative pressure therapy (ENPT).
      However, the high cost of this novel EVT system may limit the widespread use of this technique.

      Video case presentation

      In Video 1 (available online at www.giejournal.org), we highlight a cost-effective modified EVT technique for the management of transmural defects and the tools needed to perform the procedure successfully (Fig. 1).
      • de Moura D.T.H.
      • de Moura B.F.B.H.
      • Manfredi M.A.
      • et al.
      Role of endoscopic vacuum therapy in the management of gastrointestinal transmural defects.
      With this novel approach, the modified sponge is constructed using a nasogastric tube (NGT), gauze, and antimicrobial incise drape. We demonstrate the step-by-step process of manufacturing the cost-effective modified EVT system in detail (Figs. 2 and 3) and describe this approach’s advantages in the management of 3 patients with GI transmural defects, including upper and lower defects.
      Figure thumbnail gr1
      Figure 1Tools for manufacturing cost-effective modified endoscopic vacuum therapy.
      Figure thumbnail gr2
      Figure 2Diagram describing the step-by-step manufacturing of the modified endoscopic vacuum therapy. NGT, Nasogastric tube.
      Figure thumbnail gr3
      Figure 3Step-by-step manufacture of the cost-effective modified endoscopic vacuum therapy. A, Wrap gauze around the fenestrated portion of the nasogastric tube. B, Wrap the antimicrobial incise drape around the fenestrated portion of the nasogastric tube. C, Fixation of the modified sponge with sutures. D, Perforation of the modified sponge. E, Functionality test. F, Sealing the connection of the tubes. G, A 20-gauge intravenous catheter connected to the tube to maintain a continuous negative pressure between –75 and –150 mmHg. H, Final aspect.
      The first case involved a 60-year-old woman with a history of achalasia, who underwent a Heller myotomy with partial fundoplication. On the third postoperative day, she presented with an esophageal leak, and a surgical suture repair with pleural and mediastinal drainage was performed (Fig. 4). Index EGD was performed with CO2 insufflation on postoperative day 8 and revealed multiple esophageal transmural defects. At this time, modified EVT was performed using an 18F NGT. Ten days after initial EVT placement, the patient's clinical condition improved and an EVT exchange was performed. During this endoscopy, an external drain was identified and then removed to allow adequate negative pressure. In addition, septotomy was performed to allow for communication of all orifices and improve overall drainage. A nasoenteral feeding tube was then placed to improve nutrition. On postoperative day 28 (10 days after the first EVT exchange), a second EVT exchange was performed after foreign body (suture) removal. Finally, 1 month after the index endoscopy (3 EVT placements and 2 EVT exchanges), the esophageal defect was completely healed.
      Figure thumbnail gr4
      Figure 4A, Esophageal leaks after Heller myotomy. B, Final appearance after endoscopic treatment.
      The second case involved a 56-year-old man with class II obesity who presented to our institution with a leak 3 weeks after laparoscopic conversion from Roux-en-Y gastric bypass to sleeve gastrectomy. There was evidence of a small collection adjacent to the staple line at the proximal stomach (angle of His). EGD was performed using an underwater technique without air or CO2 insufflation to avoid disruption of the collection because the patient did not have external drainage. For this case, the patient was treated with the modified EVT using a widely available triple-lumen tube to allow for nutrition and drainage via a single tube through the nares, reducing patient discomfort and improving treatment compliance.
      • de Moura D.T.H.
      • do Monte Junior E.S.
      • Hathorn K.E.
      Modified endoscopic vacuum therapy in the management of a duodenal transmural defect.
      After 2 weeks, there was complete resolution of the leak with no need for EVT system exchange (Fig. 5).
      Figure thumbnail gr5
      Figure 5A, Postbariatric esophageal leak. B, Complete closure after modified endoscopic vacuum therapy treatment.
      The last case involved a 72-year-old woman with a history of an early colocutaneous fistula after a left hemicolectomy due to acute diverticulitis. On postoperative day 28, she underwent a colon resection with diverting ileostomy and external drain placement. Colonoscopy was performed approximately 2 weeks after the revisional surgery owing to development of purulent rectal discharge. At this time, a leak was identified adjacent to the colorectal anastomosis with a large infected collection (Fig. 6). The previously placed external drain inside the collection was removed and a compressive dressing was placed to allow for negative pressure promoted by the modified EVT system that was introduced in an intracavitary position during the procedure. Weekly EVT system exchanges were performed to reduce the size of the modified sponge as the collection healed. After 4 weeks of treatment (a total of 4 EVTs), there was significant reduction of the collection and granulation tissue without signs of infection. Therefore, EVT was concluded. The patient remained clinically stable and was discharged 3 days later. At 1-month follow-up, CT scan revealed complete resolution of the collection, and colonoscopy showed complete repair of the wall defect.
      Figure thumbnail gr6
      Figure 6A, Leak at the colorectal anastomosis. B, Intracavitary modified endoscopic vacuum therapy. C, Removal of the external drain. D, Reduction of the collection with granulation tissue and no signs of infection. E, Fluoroscopy showing reduction of the collection. F, Complete repair of the wall defect.

      Discussion

      Among the advantages of this modified EVT device are lower cost, easy insertion through the nares (in upper GI defects) or through the rectum (in lower GI defects), reduced procedure time, longer interval between EVT system exchanges, and less tissue ingrowth, resulting in fewer adverse events such as bleeding.
      • de Moura D.T.H.
      • do Monte Junior E.S.
      • Hathorn K.E.
      Modified endoscopic vacuum therapy in the management of a duodenal transmural defect.
      ,
      • de Moura D.T.H.
      • do Monte Junior E.S.
      • Hathorn K.E.
      • et al.
      The use of novel modified endoscopic vacuum therapies in the management of a transmural rectal wall defect.
      Based on the individual defect characteristics and the presence of an associated collection, the sponge system may be placed intraluminal or intracavitary. It is recommended to place the EVT system inside the cavity when an associated collection is diagnosed.
      • de Moura D.T.H.
      • Sachdev A.H.
      • Thompson C.C.
      Endoscopic full-thickness defects and closure techniques.
      The output volume depends on whether the vacuum therapy is intracavitary or intraluminal, if there is active infection with purulent content, and if the patient is on an oral liquid diet. The decision to conclude therapy should be based on clinical status, endoscopic findings, and imaging studies.
      Despite several benefits associated with the EVT approach, other alternatives and possible disadvantages related to EVT use, such as patient discomfort and longer hospital stay, should be discussed before a decision is made. Overall, other modalities such as SEMs are considered a more traditional method with more widespread adoption and clinical experience. Interestingly, in our experience and according to recent studies, the use of conventional esophageal SEMSs and specific customized SEMSs for sleeve gastrectomy has been associated with a high rate of adverse events such as gastroesophageal reflux symptoms, pain, nausea and vomiting, and stent migration.
      • Okazaki O.
      • Bernardo W.M.
      • Brunaldi V.O.
      • et al.
      Efficacy and safety of stents in the treatment of fistula after bariatric surgery: a systematic review and meta-analysis.
      • Hamid H.K.S.
      • Emile S.H.
      • Saber A.A.
      • et al.
      Customized bariatric stents for sleeve gastrectomy leak: are they superior to conventional esophageal stents? A systematic review and proportion meta-analysis.
      • de Moura D.T.H.
      • de Moura E.G.H.
      • Neto M.G.
      • et al.
      Outcomes of a novel bariatric stent in the management of sleeve gastrectomy leaks: a multicenter study.
      In addition, a recent meta-analysis comparing stent versus EVT in upper GI defects showed higher rates of successful closure, a reduction in treatment duration, and lower mortality rates—all favoring the EVT group.

      do Monte Junior ES, de Moura DTH, Ribeiro IB, et al. Endoscopic vacuum therapy versus endoscopic stenting for upper gastrointestinal transmural defects: systematic review and meta-analysis. Dig Endosc. Epub 2020 Aug 16.

      It is critical to understand that patients with transmural defects, especially those with leaks, remain challenging, and an individualized approach is required. All therapies have potential advantages and disadvantages, and treatment decisions must be individualized.
      • Sachdev A.H.
      • Iqbal S.
      • Ribeiro I.B.
      • et al.
      Use of omental patch and endoscopic closure technique as an alternative to surgery after endoscopic full thickness resection of gastric intestinal stromal tumors: a series of cases.
      • Barrichello Junior S.A.
      • Ribeiro I.B.
      • Fittipaldi-Fernandez R.J.
      • et al.
      Exclusively endoscopic approach to treating gastric perforation caused by an intragastric balloon: case series and literature review.
      • Cereatti F.
      • Grassia R.
      • Drago A.
      • et al.
      Endoscopic management of gastrointestinal leaks and fistulae: what option do we have?.

      de Moura DTH, Boghossian MB, Hirsch BS, et al. Long-term endoscopic follow-up after closure of a post-bariatric surgery fistula with a cardiac septal defect occluder. Endoscopy. Epub 2021 Aug 16.

      Boghossian MB, Funari MP, do Monte Junior ES, et al. Endoscopic septotomy for fistula after bariatric surgery. Endoscopy. Epub 2021 Feb 19.

      • de Moura E.G.
      • Silva G.L.
      • de Moura E.T.
      • et al.
      Esophageal perforation after epicardial ablation: an endoscopic approach.
      Until now, there has been a relative lack of data to support any technique as a criterion standard method, and often more than 1 intervention is required. Ultimately, a multidisciplinary approach remains essential, and personal and local experience should be considered when choosing the best treatment strategy.

      Conclusion

      This modified EVT system appears to be a feasible, safe, and effective alternative for the management of transmural GI defects. In our experience, this technique is associated with high technical and clinical success rates with no adverse events. The modified EVT is easily inserted and increases the interval between the EVT system exchanges. This cost-effective technique may expand EVT use by providing less-invasive treatment to more patients around the world, especially in developing countries.

      Disclosure

      Dr Thompson is a consultant for USGI Medical, Apollo Endosurgery, Boston Scientific, Covidien/Medtronic, Fractyl, GI Dynamics, and Olympus/Spiration; does research support for USGI Medical, Aspire Bariatrics, Apollo Endosurgery, GI Dynamics, Olympus/Spiration, and Spatz; is a general partner with BlueFlame Healthcare Venture Fund; is a board member of EnVision Endoscopy; is an advisory board member of Fractyl; and has ownership interest in GI Windows. Dr Guimarães Hourneaux de Moura is a consultant for Boston Scientific and Olympus. All other authors disclosed no financial relationships.

      Supplementary data

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