Endoscopic Vacuum TherapyNCT05606822
Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract
An observational study of Endoscopic Vacuum Therapy and Anastomotic Leak, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Vacuum Therapy, Anastomotic Leak, Esophageal Perforation
- What is being tested?
- Observational
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2021to 1 Oct 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients treated with EVT for a transmural defect in the upper GI tract, including anastomotic leakage, Boerhaave syndrome, iatrogenic perforations, trauma, etc.
Who may be able to join
- Treated with EVT for anastomotic leakage after esophago-gastric surgery
- Signed informed consent form
- 18 years or older
Who cannot join
- No signed informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Centers, location VUmc
Amsterdam
Roos Pouw, MD, PhD, r.e.pouw@amsterdamumc.nl
Lisanne Pattynama, MD
About this study
Official title: Endoscopic Vacuum Therapy for Anastomotic Leakage After Upper Gastrointestinal Surgery / Endoscopic Vacuum Therapy for Esophageal Perforation: A Multicenter Retrospective Cohort Study
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:
- What is the success rate of EVT for transmural defects in the upper GI tract?
- What are the best indications for EVT in the upper GI tract? (e.g. etiology, patient characteristics, defect characteristics)
- What are the best techniques for EVT in the upper GI tract? (e.g. EsoSponge, VACStent, vacuum pressure, intraluminal/intracavitary) Participants will be asked for informed consent to retrospectively and prospectively collect data on EVT.
Read the detailed description
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.
- Conditions
- Endoscopic Vacuum Therapy, Anastomotic Leak, Esophageal Perforation, Esophageal Perforation, Traumatic, EsoSponge, VACStent
- Being tested
- Observational
- Medical subject headings
- Anastomotic Leak, Esophageal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Collection of data from electronic health record
| Study group | Role | What they receive |
|---|---|---|
| Anastomotic leakage after gastrointestinal surgery | No interventions will be administered, as this is an observational study. Receives: Other: Observational | |
| Esophageal perforation (Boerhaave syndrome, iatrogenic, trauma, other) | No interventions will be administered, as this is an observational study. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Successful treatment of EVT for the upper GI defect: closure confirmed via endoscopy
Measured: 1-3 years
Secondary outcomes (4)
Mortality
30-day and in-hospital mortality, relation to EVT
Measured: 6 months (due to possible prolonged hospital stay)
Adverse events
(Severe) adverse events related to EVT
Measured: 6 months
Treatment cycles
Including number of EVT-related endoscopies, number of used sponges/VACStents
Measured: 6 months
Duration of treatment
Including duration of treatment in days, hospital stay in days, ICU stay in days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Oct 2021
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Vacuum TherapyStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roos Pouw, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Roos Pouw, MD, PhD, Principal investigator, Amsterdam University Medical Center, location VU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606822
- Sponsor's protocol ID
- 2021.0457
- Status last verified
- Jul 2024
- First submitted
- 26 Oct 2022
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37253387Luttikhold 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.
PubMed 36828030
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Vacuum Therapy for Anastomotic Leakage After Upper Gastrointestinal Surgery / Endoscopic Vacuum Therapy for Esophageal Perforation: A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05606822
- Acronym / sponsor ID
- 2021.0457
- Conditions
- Endoscopic Vacuum Therapy, Anastomotic Leak, Esophageal Perforation, Esophageal Perforation, Traumatic, EsoSponge, VACStent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the success rate of EVT for transmural defects in the upper GI tract?
- What are the best indications for EVT in the upper GI tract? (e.g. etiology, patient characteristics, defect characteristics)
- What are the best techniques for EVT in the upper GI tract? (e.g. EsoSponge, VACStent, vacuum pressure, intraluminal/intracavitary) Participants will be asked for informed consent to retrospectively and prospectively collect data on EVT.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anastomotic leakage after gastrointestinal surgery | – | Other: ObservationalNo interventions will be administered, as this is an observational study. |
| Esophageal perforation (Boerhaave syndrome, iatrogenic, trauma, other) | – | Other: ObservationalNo interventions will be administered, as this is an observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated with EVT for a transmural defect in the upper GI tract, including anastomotic leakage, Boerhaave syndrome, iatrogenic perforations, trauma, etc.
Key inclusion criteria (3 listed)
- Treated with EVT for anastomotic leakage after esophago-gastric surgery
- Signed informed consent form
- 18 years or older
Key exclusion criteria (1 listed)
- No signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalCollection of data from electronic health record | Other | Anastomotic leakage after gastrointestinal surgery, Esophageal perforation (Boerhaave syndrome, iatrogenic, trauma, other) |
Primary outcome
Success rate
Time frame: 1-3 years
Successful treatment of EVT for the upper GI defect: closure confirmed via endoscopy
4 secondary outcomes
Mortality
Time frame: 6 months (due to possible prolonged hospital stay)
Adverse events
Time frame: 6 months
Treatment cycles
Time frame: 6 months
Duration of treatment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Derived from this study: PubMed 37253387Pattynama 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.
- Derived from this study: PubMed 36828030Luttikhold 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.
- 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 tractLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roos Pouw, MD, PhD principal investigator
Amsterdam University Medical Center, location VU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Vacuum Therapy and Anastomotic Leak, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roos Pouw, MD, PhD (+3120 4444444, r.e.pouw@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 1-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05606822, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.