Dataset Information

Vacuum-stent: A combination of endoscopic vacuum therapy and an intraluminal stent for treatment of esophageal transmural defects.

ABSTRACT:

Introduction

Endoscopic vacuum therapy (EVT) has gained a greater role in management of transmural defects in the upper gastrointestinal (GI) tract, including anastomotic leakage and esophageal perforation (e.g. Boerhaave syndrome and iatrogenic causes). The vacuum-stent is a new treatment modality, combining the benefits of EVT and an intraluminal stent.

Patients and methods

This prospective case series describes the first ten cases of a transmural defect in the upper GI tract treated with a vacuum-stent in a tertiary referral center. All patients signed informed consent for prospective registration of relevant data on treatment and outcomes in a specially designed database. Outcome parameters were successful closure of the defect, number of endoscopies, duration of treatment and adverse events.

Results

In total, ten patients treated with a vacuum-stent were included. Eight patients had anastomotic leakage after esophageal resection, of whom six were treated with vacuum-sponge and vacuum-stent, and two with vacuum-stent only. One patient had Boerhaave syndrome, treated with vacuum-sponge and vacuum-stent, and one had an iatrogenic perforation during pneumodilation for achalasia, treated with vacuum-stent only. Success rate was 100%, requiring a median of 5 (IQR 3-12) EVT-related endoscopies with a treatment course of median 18 (IQR 12-59) days. One patient developed an esophageal stricture, but no other vacuum-stent related adverse events were observed.

Conclusion

The vacuum-stent, which combines benefits of EVT and an intraluminal stent, shows great feasibility and efficacy in treatment of transmural defects in the upper GI tract. Future studies should point out whether this device can prevent major (re-)surgery in these patients.

SUBMITTER: Pattynama LMD

PROVIDER: S-EPMC10010284 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

Vacuum-stent: A combination of endoscopic vacuum therapy and an intraluminal stent for treatment of esophageal transmural defects.

Pattynama Lisanne M D LMD Eshuis Wietse J WJ van Berge Henegouwen Mark I MI Bergman Jacques J G H M JJGHM Pouw Roos E RE

Frontiers in surgery 20230222

<h4>Introduction</h4>Endoscopic vacuum therapy (EVT) has gained a greater role in management of transmural defects in the upper gastrointestinal (GI) tract, including anastomotic leakage and esophageal perforation (e.g. Boerhaave syndrome and iatrogenic causes). The vacuum-stent is a new treatment modality, combining the benefits of EVT and an intraluminal stent.<h4>Patients and methods</h4>This prospective case series describes the first ten cases of a transmural defect in the upper GI tract tr ...[more]

PMID: 36923375

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Project description:Video 1Cost-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.

Project description:BackgroundIntrathoracic anastomotic leaks represent a major complication after Ivor Lewis esophagectomy. There are two promising endoscopic treatment strategies in the case of leaks: the placement of self-expanding metal stents (SEMS) or endoscopic vacuum therapy (EVT). Up to date, there is no prospective data concerning the optimal endoscopic treatment strategy. This is a protocol description for the ESOLEAK trial, which is a first small phase 2 randomized trial evaluating the quality of life after treatment of anastomotic leaks by either SEMS placement or EVT.MethodsThis phase 2 randomized trial will be conducted at two German tertiary medical centers and include a total of 40 patients within 2 years. Adult patients with histologically confirmed esophageal cancer, who have undergone Ivor Lewis esophagectomy and show an esophagogastric anastomotic leak on endoscopy or present with typical clinical signs linked to an anastomotic leak, will be included in our study taking into consideration the exclusion criteria. After endoscopic verification of the anastomotic leak, patients will be randomized in a 1:1 ratio into two treatment groups. The intervention group will receive EVT whereas the control group will be treated with SEMS. The primary endpoint of this study is the subjective quality of life assessed by the patient using a systematic and validated questionnaire (EORTC QLQ C30, EORTC QLQ-OES18 questionnaire). Important secondary endpoints are healing rate, period of hospitalization, treatment-related complications, and overall mortality.DiscussionThe latest meta-analysis comparing implantation of SEMS with EVT in the treatment of esophageal anastomotic leaks suggested a higher success rate for EVT. The ESOLEAK trial is the first study comparing both treatments in a prospective manner. The aim of the trial is to find suitable endpoints for the treatment of anastomotic leaks as well as to enable an adequate sample size calculation and evaluate the feasibility of future interventional trials. Due to the exploratory design of this pilot study, the sample size is too small to answer the question, whether EVT or SEMS implantation represents the superior treatment strategy.Trial registrationClinicalTrials.gov NCT03962244 . Registered on May 23, 2019. DRKS-ID DRKS00007941.

Dataset Information

Vacuum-stent: A combination of endoscopic vacuum therapy and an intraluminal stent for treatment of esophageal transmural defects.

Introduction

Patients and methods

Results

Conclusion

Publications

Vacuum-stent: A combination of endoscopic vacuum therapy and an intraluminal stent for treatment of esophageal transmural defects.

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