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

Abstract

https://www.videogie.org/cms/asset/95c0acf3-09f5-476b-b8fb-d707f579a411/mmc1.mp4Loading ...(mp4, 75.94 MB) Download video 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. 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.1de Moura D.T.H. Sachdev A.H. Thompson C.C. Endoscopic full-thickness defects and closure techniques.Curr Treat Options Gastroenterol. 2018; 16: 386-405Crossref PubMed Google Scholar,2Bemelman W.A. Baron T.H. Endoscopic management of transmural defects, including leaks, perforations, and fistulae.Gastroenterology. 2018; 154: 1938-1946.e1Abstract Full Text Full Text PDF PubMed Scopus (27) Google Scholar Endoscopic therapy has become the first-line therapy in most cases,3de 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.World J Gastrointest Endosc. 2019; 11: 329-344Crossref PubMed Google Scholar,4Rogalski P. Swidnicka-Siergiejko A. Wasielica-Berger J. et al.Endoscopic management of leaks and fistulas after bariatric surgery: a systematic review and meta-analysis.Surg Endosc. 2021; 35: 1067-1087Crossref PubMed Scopus (14) Google Scholar 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).5Baptista 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.Gastrointest Endosc. 2019; 89: 671-679Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar, 6Donatelli 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.Surg Obes Relat Dis. 2021; 17: 1432-1439Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar, 7Hourneaux 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?.VideoGIE. 2018; 4: 114-117Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar, 8Haito-Chavez Y. Kumbhari V. Ngamruengphong S. et al.Septotomy: an adjunct endoscopic treatment for post-sleeve gastrectomy fistulas.Gastrointest Endosc. 2016; 83: 456-457Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar Unlike other endoscopic techniques, EVT has several mechanisms of action to promote healing, including microdeformation, macrodeformation, changes in perfusion, exudate control, and bacterial clearance.3de 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.World J Gastrointest Endosc. 2019; 11: 329-344Crossref PubMed Google Scholar 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.9de Moura D.T.H. Brunaldi V.O. Minata M. et al.Endoscopic vacuum therapy for a large esophageal perforation after bariatric stent placement.VideoGIE. 2018; 3: 346-348Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar, 10Loske G. Müller C.T. Tips and tricks for endoscopic negative pressure therapy.Chirurg. 2019; 90: 7-14Crossref PubMed Scopus (22) Google Scholar, 11de Moura D.T.H. do Monte Junior E.S. Hathorn K.E. Modified endoscopic vacuum therapy in the management of a duodenal transmural defect.Endoscopy. 2021; 53: E17-E18Crossref PubMed Scopus (3) Google Scholar, 12Kuehn F. Loske G. Schiffmann L. et al.Endoscopic vacuum therapy for various defects of the upper gastrointestinal tract.Surg Endosc. 2017; 31: 3449-3458Crossref PubMed Scopus (62) Google Scholar, 13de 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.Endoscopy. 2021; 53: E27-E28Crossref PubMed Scopus (2) Google Scholar 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.14Loske G. Schorsch T. Rucktaeschel F. et al.Open-pore film drainage (OFD): a new multipurpose tool for endoscopic negative pressure therapy (ENPT).Endosc Int Open. 2018; 6: E865-E871Crossref PubMed Google Scholar However, the high cost of this novel EVT system may limit the widespread use of this technique. 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).3de 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.World J Gastrointest Endosc. 2019; 11: 329-344Crossref PubMed Google Scholar 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 2Diagram describing the step-by-step manufacturing of the modified endoscopic vacuum therapy. NGT, Nasogastric tube.View Large Image Figure ViewerDownload Hi-res image Download (PPT)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.View Large Image Figure ViewerDownload Hi-res image Download (PPT) 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. 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.11de Moura D.T.H. do Monte Junior E.S. Hathorn K.E. Modified endoscopic vacuum therapy in the management of a duodenal transmural defect.Endoscopy. 2021; 53: E17-E18Crossref PubMed Scopus (3) Google Scholar After 2 weeks, there was complete resolution of the leak with no need for EVT system exchange (Fig. 5). 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. 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.11de Moura D.T.H. do Monte Junior E.S. Hathorn K.E. Modified endoscopic vacuum therapy in the management of a duodenal transmural defect.Endoscopy. 2021; 53: E17-E18Crossref PubMed Scopus (3) Google Scholar,13de 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.Endoscopy. 2021; 53: E27-E28Crossref PubMed Scopus (2) Google Scholar 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.1de Moura D.T.H. Sachdev A.H. Thompson C.C. Endoscopic full-thickness defects and closure techniques.Curr Treat Options Gastroenterol. 2018; 16: 386-405Crossref PubMed Google Scholar 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.15Okazaki 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.Obes Surg. 2018; 28: 1788-1796Crossref PubMed Scopus (49) Google Scholar, 16Hamid 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.Surg Endosc. 2021; 35: 1025-1038Crossref PubMed Scopus (6) Google Scholar, 17de 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.Surg Obes Relat Dis. 2019; 15: 1241-1251Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar 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.18do 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.Google Scholar 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.19Sachdev 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.World J Clin Cases. 2020; 8: 120-125Crossref PubMed Scopus (2) Google Scholar, 20Barrichello 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.Endosc Int Open. 2018; 6: E1322-E1329Crossref PubMed Google Scholar, 21Cereatti F. Grassia R. Drago A. et al.Endoscopic management of gastrointestinal leaks and fistulae: what option do we have?.World J Gastroenterol. 2020; 26: 4198-4217Crossref PubMed Google Scholar, 22de 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.Google Scholar, 23Boghossian MB, Funari MP, do Monte Junior ES, et al. Endoscopic septotomy for fistula after bariatric surgery. Endoscopy. Epub 2021 Feb 19.Google Scholar, 24de Moura E.G. Silva G.L. de Moura E.T. et al.Esophageal perforation after epicardial ablation: an endoscopic approach.Endoscopy. 2015; 47: E592-E593Crossref PubMed Scopus (7) Google Scholar 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. 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.

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