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The goal of this observational study is to learn about the best indications and techniques regarding endoscopic vacuum therapy (EVT) in patients with a transmural defect in the upper gastrointestinal (GI) tract (e.g. anastomotic leakage, Boerhaave syndrome, iatrogenic perforation, other). The main questions it aims to answer are:
Transmural defects in the upper gastrointestinal (GI) tract are defined as a disruption or injury extending through all layers of the oesophageal or gastric wall. These defects can result from various causes, including anastomotic leakage (AL) after oesophago-gastric surgery, iatrogenic perforation, Boerhaave syndrome, or trauma. Transmural defects in the upper GI tract are associated with serious consequences, such as leakage of saliva, gastric contents, and bile into the mediastinum, triggering an inflammatory response. Untreated or inadequately managed mediastinitis can lead to serious morbidity, sepsis, and mortality. Therefore, timely diagnosis and treatment of these defects is crucial. There are several treatment options for transmural defects in the upper GI tract. Conservative management involves a nil by mouth protocol, antibiotics, and (percutaneous) drainage. Endoscopic treatments include self-expandable metallic stents (SEMS), through-the-scope clips, over-the-scope clips, suturing with overstitch, and most recently, endoscopic vacuum therapy (EVT). Historically, SEMS has been the most used treatment option for transmural defects in the upper GI tract. However, persisting leakage and complications such as dislocation of the stent are not uncommon. Besides that, not all defects are suitable for stenting and additional percutaneous drainage is often necessary, but not always possible. Surgical treatment, such as a re-anastomosis or resection of the gastric conduit with construction of a cervical esophagostomy is generally required in severely septic patients. The choice of treatment depends on factors such as the location and size of the leakage, severity of symptoms, and presence of conduit ischemia or necrosis. In the past decade, EVT has been established as an effective and safe endoscopic treatment option, and it was found to be superior in terms of success rate in AL healing compared to other treatments. However, the implementation of EVT in clinical practice might be hindered by multiple challenges and questions regarding indications and techniques. This study aims to answer remaining questions and bundle expertise, to be able to determine the best indications and techniques of EVT, to reach the full potential of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anastomotic leakage after gastrointestinal surgery | No interventions will be administered, as this is an observational study. |
| |
| Esophageal perforation (Boerhaave syndrome, iatrogenic, trauma, other) | No interventions will be administered, as this is an observational study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Collection of data from electronic health record |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate | Successful treatment of EVT for the upper GI defect: closure confirmed via endoscopy | 1-3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 30-day and in-hospital mortality, relation to EVT | 6 months (due to possible prolonged hospital stay) |
| Adverse events | (Severe) adverse events related to EVT |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with EVT for a transmural defect in the upper GI tract, including anastomotic leakage, Boerhaave syndrome, iatrogenic perforations, trauma, etc.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roos Pouw, MD, PhD | Contact | +3120 4444444 | r.e.pouw@amsterdamumc.nl | |
| Lisanne Pattynama, MD | Contact | +3120 4444444 | l.m.pattynama@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Roos Pouw, MD, PhD | Amsterdam University Medical Center, location VU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam University Medical Centers, location VUmc | Recruiting | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37253387 | Derived | Pattynama LMD, Pouw RE, Henegouwen MIVB, Daams F, Gisbertz SS, Bergman JJGHM, Eshuis WJ. Endoscopic vacuum therapy for anastomotic leakage after upper gastrointestinal surgery. Endoscopy. 2023 Nov;55(11):1019-1025. doi: 10.1055/a-2102-1691. Epub 2023 May 30. | |
| 36828030 | Derived | Luttikhold J, Pattynama LMD, Seewald S, Groth S, Morell BK, Gutschow CA, Ida S, Nilsson M, Eshuis WJ, Pouw RE. Endoscopic vacuum therapy for esophageal perforation: a multicenter retrospective cohort study. Endoscopy. 2023 Sep;55(9):859-864. doi: 10.1055/a-2042-6707. Epub 2023 Feb 24. |
| Label | URL |
|---|---|
| Pattynama, L. M. D. et al (2024). Multi-modality management of defects in the gastrointestinal tract: Where the endoscope meets the scalpel: Endoscopic vacuum therapy in the upper gastrointestinal tract | View source |
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| 6 months |
| Treatment cycles | Including number of EVT-related endoscopies, number of used sponges/VACStents | 6 months |
| Duration of treatment | Including duration of treatment in days, hospital stay in days, ICU stay in days | 6 months |
| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| D004939 | Esophageal Perforation |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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