Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04362605 |
| Other study ID # |
UTuebingen |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
January 20, 2020 |
Study information
| Verified date |
February 2020 |
| Source |
University Hospital Tuebingen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Endoscopic negative pressure therapy (ENPT):
OPD: The commercially available Eso-SPONGE® System (B. Braun Melsungen AG, Melsungen,
Germany) was used for endoluminal vacuum therapy. For positioning the OPD in loop-technique a
loop (MersileneTM, Polyester, 4 Ph. Eur., Ethicon®, Norderstedt, Germany) is fixed at the
distal end of the drainage, gripped with an endoscopic grasper and placed under endoscopic
view. Endoscopic placement took place via oral intubation of the esophagus with finally
oro-nasal redirection and fixation with plasters.
OFD: The OFD for endoluminal therapy is handmade, as previously described, by wrapping a thin
open-pore double-layered drainage film (Suprasorb® CNP, Drainage Film; Lohmann & Rauscher
International GmbH & Co.KG, Rengsdorf, Germany) on the distal end of a small caliber redon
drain, a gastric tube or the gastric segment of a naso-jejunal feeding tube (Freka®
Trelumina, Fresenius Kabi Deutschland GmbH, Bad Homburg Germany). Sutures (MersileneTM,
Polyester, 4 Ph. Eur., Ethicon®, Norderstedt, Germany) were used for the fixation of the
drainage film around the tube. Drain insertion took place via nasal positioning and
endoscopic guiding with grasper. Venting tubes in tri-lumen enteral feeding tubes has to be
closed for ENPT.
Controlled Negative Pressure: A continuous vacuum of -125 mmHg is generated by electronic
vacuum devices (KCI V.A.C. Ulta or V.A.C. Freedom; KCI USA Inc., San Antonio, TX, USA).
Procedural informations: In patients with suspected EJAL 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.
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.
Re-endoscopy was performed after 3-7 days. In the case of persisting leak or in the case of
uncertainty, the new ENPT system was re-inserted and treatment was continued. In patients
with OPD change interval was 3-4 days, in patients treated with OFD interval was longer up to
7 days. Success was defined as complete closure of the perforation.
In patients with a good clinical situation with endoluminale placed OFD swallow of liquids is
allowed.
Database:
An analysis was performed using SPSS v. 24.0.0.1 (IBM, Armonk, NY, USA). Data were presented
as means ± SD.
Results Eight patients (4 females and 4 males with a mean age of 61.39 ± 12.92 years) were
treated with ENPT for EJL. Patient's characteristics are presented in Table 2.
Mean time point of diagnosis the EJAL was day 6.25 ± 2.54 after resection. Three patients
were treated at the ICU at the time of diagnosis of the EJAL. Symptoms that caused suspicion
of EJAL were respiratory insufficiency, conspicuous secretion via drains, fever, and elevated
inflammatory markers. All patients were treated and observed on ICU after detection an start
of ENPT.
Findings of the index endoscopy varied strongly. Circumscribed insufficiencies, large
leakages with secretion of putrid fluids or fibrin coated anastomosis with exposed clamps
were seen. In Figure 1 and 2 examples of endoscopic finding during the index endoscopy are
presented.
First treatment mode in all patients with EJAL was endoluminale ENPT. In five patients ENPT
was performed with OPD and in three patients with OFD. In one obese patient with a complete
anastomotic avulsion ENPT was changed to SEMS-therapy. Treatment characteristics are
summarized in Table 3.
In order to achieve sepsis control additional surgery was indicated in seven of eight
patients. Number of needed re-operations varied strongly.
Enteral feeding was established in all patients. Enteral feeding was ensured by nutrition
tubes combined with ENPT through OFD in five patients and via needle catheter jejunostomy in
three patients.
In seven patients treated with ENPT for EJAL therapy combined with surgery for sepsis control
was successful. In five final endoscopic reports any dehiscences or insufficiencies were
characterized and in two reports small and clean insufficiencies with good wound granulation
were described.
A later endoscopic intervention of a post-treatment stenosis of the anastomosis was not
detected in the analyzed patients.
Conclusion ENPT is a promising tool for treating EJAL. Furthermore, comparative studies
between ENPT and other endoscopic treatment options for EJAL are needed to determine the best
management options and indications for combined surgical interventions.
We recommend ENPT in endoluminal position in patients who suffered from EJAL combined with
additional surgery if required to treat pleural or abdominal septic collections.
