Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

NCT ID: NCT05606822

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2030-10-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Anastomotic leakage after gastrointestinal surgery

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

Observational

Intervention Type: OTHER

Collection of data from electronic health record

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

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

Observational

Intervention Type: OTHER

Collection of data from electronic health record

Interventions

Observational

Collection of data from electronic health record

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• No signed informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Roos Pouw

Principle Investigator, Doctor of Medicine, Doctor of Philosophy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roos Pouw, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam University Medical Center, location VU

Locations

Amsterdam University Medical Centers, location VUmc

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Roos Pouw, MD, PhD

Role: CONTACT

r.e.pouw@amsterdamumc.nl

+3120 4444444

Lisanne Pattynama, MD

Role: CONTACT

l.m.pattynama@amsterdamumc.nl

+3120 4444444

Facility Contacts

Roos Pouw, MD, PhD

Role: primary

r.e.pouw@amsterdamumc.nl

References

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.

Reference Type: DERIVED

PMID: 37253387 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36828030 (View on PubMed)

Related Links

https://doi.org/10.1016/j.bpg.2024.101901

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

Other Identifiers

2021.0457

Identifier Type: -

Identifier Source: org_study_id