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.
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.
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.
- Conditions
- Anastomotic Leak Esophagus
- 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 group | Role | What they receive |
|---|---|---|
| intervenional group | Experimental | ENPT Receives: Procedure: Endoscopic Negative Pressure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted27 Apr 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic Leak EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Series of Combined Endoscopic Negative Pressure Therapy and Surgical Treatment of Anastomotic Insufficiencies After Oncological Gastrectomies
- ClinicalTrials.gov ID
- NCT04362605
- Acronym / sponsor ID
- UTuebingen
- Conditions
- Anastomotic Leak Esophagus
- Keywords
- endoscopic negative pressure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients after gastrectomy who suffer from anastomotic leak
| Arm | Type | Receives |
|---|---|---|
| intervenional group | Experimental | Procedure: Endoscopic Negative Pressure TherapyENPT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- anastomotic leak after oncological gastrectomy
Key exclusion criteria (1 listed)
- all other patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Negative Pressure TherapyAlso: Endoscopic Vacuum Therapy, Endoscopic Vacuum Assisted ClosureIn 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. | Procedure or surgery | intervenional group |
Primary outcome
mortality rate
Time frame: 30 days after surgery
death by anastomotic leak
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.