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Anastomotic Leak EsophagusNCT04362605

Endoscopic Negative Pressure Therapy After Oncological Gastrectomies

A study testing Endoscopic Negative Pressure Therapy in people with Anastomotic Leak Esophagus, run by University Hospital Tuebingen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anastomotic Leak Esophagus
What is being tested?
Endoscopic Negative Pressure Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteGermany
Study dates
1 Jan 2018to 20 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • anastomotic leak after oncological gastrectomy

Who cannot join

  • all other patients

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • University Hospital of Tuebingen

    Tübingen, 72076

Other trials in Germany

About this study

Official title: Case Series of Combined Endoscopic Negative Pressure Therapy and Surgical Treatment of Anastomotic Insufficiencies After Oncological Gastrectomies

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.

Read more

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.

Read the detailed 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.

Being tested
Endoscopic Negative Pressure Therapy
Keywords
endoscopic negative pressure therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Negative Pressure TherapyProcedure or surgery

    Also called Endoscopic Vacuum Therapy, Endoscopic Vacuum Assisted Closure

    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.

Study groups in NCT04362605
Study groupRoleWhat they receive
intervenional groupExperimentalENPT
Receives: Procedure: Endoscopic Negative Pressure Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality rate

    death by anastomotic leak

    Measured: 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2020
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 2019
  4. Study completion20 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Patients after gastrectomy who suffer from anastomotic leak
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04362605
Sponsor's protocol ID
UTuebingen
Status last verified
Feb 2020
First submitted
25 Feb 2020
Last updated
27 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic Negative Pressure Therapy in people with Anastomotic Leak Esophagus, run by University Hospital Tuebingen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mortality rate (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.

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