Endoscopic Negative Pressure Therapy After Oncological Gastrectomies

NCT04362605 | Completed

• 1 other identifier: UTuebingen
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

endoscopic negative pressure therapy

Outcome Measures

Primary Outcomes (1)

• mortality rate

  death by anastomotic leak

  30 days after surgery

Study Arms (1)

intervenional group

EXPERIMENTAL

ENPT

Procedure: Endoscopic Negative Pressure Therapy

Interventions

Endoscopic Negative Pressure Therapy PROCEDURE

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.

Also known as: Endoscopic Vacuum Therapy, Endoscopic Vacuum Assisted Closure

intervenional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• anastomotic leak after oncological gastrectomy

You may not qualify if:

• all other patients

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital of Tuebingen

Tübingen, 72076, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients after gastrectomy who suffer from anastomotic leak

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: April 27, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 20, 2020
• Last Updated: April 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)