NCT05606822

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Oct 2021Oct 2030

Study Start

First participant enrolled

October 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

9 years

First QC Date

October 26, 2022

Last Update Submit

July 19, 2024

Conditions

Endoscopic Vacuum TherapyAnastomotic LeakEsophageal PerforationEsophageal Perforation, TraumaticEsoSpongeVACStent

Outcome Measures

Primary Outcomes (1)

  • Success rate

    Successful treatment of EVT for the upper GI defect: closure confirmed via endoscopy

    1-3 years

Secondary Outcomes (4)

  • Mortality

    6 months (due to possible prolonged hospital stay)

  • Adverse events

    6 months

  • Treatment cycles

    6 months

  • Duration of treatment

    6 months

Study Arms (2)

Anastomotic leakage after gastrointestinal surgery

No interventions will be administered, as this is an observational study.

Other: Observational

Esophageal perforation (Boerhaave syndrome, iatrogenic, trauma, other)

No interventions will be administered, as this is an observational study.

Other: Observational

Interventions

ObservationalOTHER

Collection of data from electronic health record

Anastomotic leakage after gastrointestinal surgeryEsophageal perforation (Boerhaave syndrome, iatrogenic, trauma, other)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated with EVT for a transmural defect in the upper GI tract, including anastomotic leakage, Boerhaave syndrome, iatrogenic perforations, trauma, etc.

You may qualify if:

  • Treated with EVT for anastomotic leakage after esophago-gastric surgery
  • Signed informed consent form
  • years or older

You may not qualify if:

  • No signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Medical Centers, location VUmc

Amsterdam, Netherlands

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37253387DERIVED

  • 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.

    PMID: 36828030DERIVED

Related Links

MeSH Terms

Conditions

Anastomotic LeakEsophageal Perforation

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Roos Pouw, MD, PhD

    Amsterdam University Medical Center, location VU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roos Pouw, MD, PhD

CONTACT

+3120 4444444r.e.pouw@amsterdamumc.nl

Lisanne Pattynama, MD

CONTACT

+3120 4444444l.m.pattynama@amsterdamumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, Doctor of Medicine, Doctor of Philosophy

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 7, 2022

Study Start

October 1, 2021

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations

NL(1)