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Endoscopic Negative Pressure Therapy After Oncological Gastrectomies

NCT04362605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-04-27

No results posted yet for this study

Summary

Background and study aims: Management of esophago-jejunal anastomotic leackages (EJAL) after gastric resections is challenging. Endoscopic negative pressure therapy (ENPT) is an emerging effective tool for treatment of gastrointestinal and anastomotic leaks. We use ENPT for EJAL after oncological gastric resections as first line therapy since 2018. The aim of the study was to present our results with this strategy by a case series.

Patients and methods: Eight patients were treated with ENPT for EJAL after oncological gastric resections between 01.2018 and 12.2019. A retrospective analysis of patient's and therapy related data was performed.

Results: Time of detection was 6.25 ± 2.54 days after surgery. After 15.63 ± 9.92 days of ENPT, 6.43 ± 3.66 endoscopies and 38.75 ± 17.35 days of hospitalization, endoscopic treatment with ENPT combined with minimal-surgery for sepsis-control was effective in seven of eight patients. In one patients treatment was changed to Stent-based therapy combined with further surgical interventions.

Conclusions: ENPT is one step in the complication management of patients with anastomotic insufficiencies after oncological gastric resections. It can be recommended in combination with minimal invasive surgery for sepsis-control. Success of ENPT for EJAL seams to be dependent on the age and size of the insufficiency and the clinical situation of the patient.

Conditions

  • Anastomotic Leak Esophagus

Interventions

PROCEDURE

Endoscopic Negative Pressure Therapy

In patients with suspected insufficiency of the esophagojejunostomy first an index endoscopy under general anesthesia with endotracheal intubation was indicated. Standard gastroscopes with outer diameter of 9.8mm were used with carbon dioxide insufflation. Definition of a anastomotic leak were endoscopic or radiological dehiscences at the esophagojejunostomy with extravasation of fluids and gas. In cases of insufficiencies start of endoluminal ENPT were indicated. Decision criteria for placement of OPD or OFD were the defect size, radiological findings and clinical situation of the patient. A CT scan in patients with suspected EJAL was done in all cases. For endoluminal ENPT, the open-pore drainage system is placed within the lumen of the digestive tract at the entrance to the cavity.

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-12-31
Completion
2020-01-20

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04362605 on ClinicalTrials.gov