Leaks, AnastomoticEsoLeakNCT03962244
Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy
An observational study of Leaks, Anastomotic, run by University Hospital of Cologne at 2 sites in Germany.
Trial summary
Exploratory study of the efficiency of endoscopic stenting versus endoscopic vacuum therapy in patients with intrathoracic esophago-gastric anastomotic leakage after oncological resection of the esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leaks, Anastomotic
- What is being tested?
- EsoSponge and Self-Expanding Metal Stent
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- 1 May 2021to 31 Dec 2023
- Phase
- Observational
- 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
Study population: Patient with an intrathoracic esophago-gastric anastomotic leak after oncologic esophagectomy (Ivor-Lewis).
Who may be able to join
- Histologically confirmed oesophageal carcinoma or similarly operated neoplasia (e.g., GIST, NET, subepithelial tumors)
- Esophagectomy with an intrathoracic esophago-gastric anastomosis
- Radiologically or endoscopically diagnosed esophago-gastric anastomotic leakage
- Clinical symptoms / symptoms due to insufficiency or increase in signs of inflammation, most likely as a result of anastomotic leakage
- Age ≥18 years
- To empower the patient to understand the scope of the study and its consequences or information, to consent to it and to sign the educational documents.
- Written declaration of consent of the patient to be included. If the patient is unable to sign by hand, a witness must confirm the oral examination by signature.
Who cannot join
- Macroscopically incompletely resected tumor (R2), palliative resection
- Endoscopically verified necrosis or critical ischemia of the anastomotic region of the interponate
- Size of insufficiency more than 50% of circumference
- Impossibility of radiological interventional insertion of a drainage
- Early anastomotic leak (≤ 48 hours postoperatively), late insufficiencies (> 4 weeks)
- Therapeutic anticoagulation
- Severe septic shock that indicates surgical therapy
- Pregnant and lactating women
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
SeungHun Chon, MD, +49 221 478 4864, seung-hun.chon@uk-koeln.de
Seung-Hun Chon, MD
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg
Michael Tachezy, MD, mtachezy@uke.de
About this study
Official title: Endoscopic Management of ESOphago-gastric Anastomotic LEAKages (EsoLeak): Stent Therapy Versus Endoscopic Vacuum Therapy
Exploratory study of the efficiency of endoscopic stenting versus endoscopic vacuum therapy in patients with intrathoracic esophago-gastric anastomotic leakage after oncological resection of the esophagus.
Read the detailed description
We analyze the outcome of using self-expanding metal stents (SEMS) and endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy.
- Conditions
- Leaks, Anastomotic
- Being tested
- EsoSponge, Self-Expanding Metal Stent
- Keywords
- Esophagectomy, Esophageal Cancer, Vacuum therapy, Stents
- Medical subject headings
- Anastomotic Leak, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsoSpongeDevice
Also called Negative pressure wound therapy
Endoscopically placed an EsoSponge for Negative pressure wound therapy in the area of the esophagogastric anastomotic leaks
Self-Expanding Metal StentDevice
Also called SEMS, stent
Endoscopically placed self-expanding-metal-stent (SEMS) for negative pressure wound therapy in the area of the esophagogastric anastomotic leaks
| Study group | Role | What they receive |
|---|---|---|
| SEMS Group | The outcome of using self-expanding metal stents (SEMS) in the treatment of postoperative leakage after esophagogastrostomy Receives: Device: Self-Expanding Metal Stent | |
| EVT Group | The outcome of using endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy Receives: Device: EsoSponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction of treatment assessed by EORTC QLQ - OES18
Assessing the quality of life of patients during the treatment of stent and EVT with a questionnaire by EORTC QLQ - OES18. This Questionnaire was developed to assess the quality of life of cancer patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 May 2021 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Leaks, AnastomoticStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Seung-Hun Chon, University Hospital of Cologne
- Investigators
- Seung-Hun Chon, MD, Principal investigator, University Hospital of CologneMichael Tachezy, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf (UKE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962244
- Sponsor's protocol ID
- 19-1201
- Acronym
- EsoLeak
- Status last verified
- Apr 2021
- First submitted
- 21 May 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bartella I, Mallmann C, Burger M, Toex U, Goeser T, Bruns C, Chon SH. Stent-over-sponge (SOS): a rescue option in patients with complex postoperative anastomotic leaks after esophagectomy. Endoscopy. 2019 Aug;51(8):E227-E228. doi: 10.1055/a-0885-9659. Epub 2019 May 2. No abstract available.
PubMed 31049889Berlth F, Bludau M, Plum PS, Herbold T, Christ H, Alakus H, Kleinert R, Bruns CJ, Holscher AH, Chon SH. Self-Expanding Metal Stents Versus Endoscopic Vacuum Therapy in Anastomotic Leak Treatment After Oncologic Gastroesophageal Surgery. J Gastrointest Surg. 2019 Jan;23(1):67-75. doi: 10.1007/s11605-018-4000-x. Epub 2018 Oct 29.
PubMed 30374816Grimminger PP, Goense L, Gockel I, Bergeat D, Bertheuil N, Chandramohan SM, Chen KN, Chon SH, Denis C, Goh KL, Gronnier C, Liu JF, Meunier B, Nafteux P, Pirchi ED, Schiesser M, Thieme R, Wu A, Wu PC, Buttar N, Chang AC. Diagnosis, assessment, and management of surgical complications following esophagectomy. Ann N Y Acad Sci. 2018 Dec;1434(1):254-273. doi: 10.1111/nyas.13920. Epub 2018 Jul 8.
PubMed 29984413Chon SH, Toex U, Plum PS, Fuchs C, Kleinert R, Bruns C, Goeser T. Successful closure of a gastropulmonary fistula after esophagectomy using the Apollo Overstitch and endoscopic vacuum therapy. Endoscopy. 2018 Jul;50(7):E149-E150. doi: 10.1055/a-0592-6384. Epub 2018 Apr 13. No abstract available.
PubMed 29653446Bludau M, Fuchs HF, Herbold T, Maus MKH, Alakus H, Popp F, Leers JM, Bruns CJ, Holscher AH, Schroder W, Chon SH. Results of endoscopic vacuum-assisted closure device for treatment of upper GI leaks. Surg Endosc. 2018 Apr;32(4):1906-1914. doi: 10.1007/s00464-017-5883-4. Epub 2017 Dec 7.
PubMed 29218673Mandarino FV, Barchi A, Leone L, Fanti L, Azzolini F, Viale E, Esposito D, Salmeri N, Puccetti F, Barbieri L, Cossu A, Treppiedi E, Elmore U, Rosati R, Danese S. Endoscopic vacuum therapy versus self-expandable metal stent for treatment of anastomotic leaks < 30 mm following oncologic Ivor-Lewis esophagectomy: a matched case-control study. Surg Endosc. 2023 Sep;37(9):7039-7050. doi: 10.1007/s00464-023-10213-8. Epub 2023 Jun 23.
PubMed 37353654Tachezy M, Chon SH, Rieck I, Kantowski M, Christ H, Karstens K, Gebauer F, Goeser T, Rosch T, Izbicki JR, Bruns CJ. Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial. Trials. 2021 Jun 2;22(1):377. doi: 10.1186/s13063-021-05315-4.
PubMed 34078426
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Management of ESOphago-gastric Anastomotic LEAKages (EsoLeak): Stent Therapy Versus Endoscopic Vacuum Therapy
- ClinicalTrials.gov ID
- NCT03962244
- Acronym / sponsor ID
- EsoLeak / 19-1201
- Conditions
- Leaks, Anastomotic
- Keywords
- Esophagectomy, Esophageal Cancer, Vacuum therapy, Stents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 May 2019 (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.
Exploratory study of the efficiency of endoscopic stenting versus endoscopic vacuum therapy in patients with intrathoracic esophago-gastric anastomotic leakage after oncological resection of the esophagus.
Detailed description
We analyze the outcome of using self-expanding metal stents (SEMS) and endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEMS Group | – | Device: Self-Expanding Metal StentThe outcome of using self-expanding metal stents (SEMS) in the treatment of postoperative leakage after esophagogastrostomy |
| EVT Group | – | Device: EsoSpongeThe outcome of using endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with an intrathoracic esophago-gastric anastomotic leak after oncologic esophagectomy (Ivor-Lewis).
Key inclusion criteria (7 listed)
- Histologically confirmed oesophageal carcinoma or similarly operated neoplasia (e.g., GIST, NET, subepithelial tumors)
- Esophagectomy with an intrathoracic esophago-gastric anastomosis
- Radiologically or endoscopically diagnosed esophago-gastric anastomotic leakage
- Clinical symptoms / symptoms due to insufficiency or increase in signs of inflammation, most likely as a result of anastomotic leakage
- Age ≥18 years
Key exclusion criteria (8 listed)
- Macroscopically incompletely resected tumor (R2), palliative resection
- Endoscopically verified necrosis or critical ischemia of the anastomotic region of the interponate
- Size of insufficiency more than 50% of circumference
- Impossibility of radiological interventional insertion of a drainage
- Early anastomotic leak (≤ 48 hours postoperatively), late insufficiencies (> 4 weeks)
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 |
|---|---|---|
| EsoSpongeAlso: Negative pressure wound therapyEndoscopically placed an EsoSponge for Negative pressure wound therapy in the area of the esophagogastric anastomotic leaks | Device | EVT Group |
| Self-Expanding Metal StentAlso: SEMS, stentEndoscopically placed self-expanding-metal-stent (SEMS) for negative pressure wound therapy in the area of the esophagogastric anastomotic leaks | Device | SEMS Group |
Primary outcome
Satisfaction of treatment assessed by EORTC QLQ - OES18
Time frame: 6 months
Assessing the quality of life of patients during the treatment of stent and EVT with a questionnaire by EORTC QLQ - OES18. This Questionnaire was developed to assess the quality of life of cancer patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Results publication: PubMed 31049889Bartella I, Mallmann C, Burger M, Toex U, Goeser T, Bruns C, Chon SH. Stent-over-sponge (SOS): a rescue option in patients with complex postoperative anastomotic leaks after esophagectomy. Endoscopy. 2019 Aug;51(8):E227-E228. doi: 10.1055/a-0885-9659. Epub 2019 May 2. No abstract available.
- Results publication: PubMed 30374816Berlth F, Bludau M, Plum PS, Herbold T, Christ H, Alakus H, Kleinert R, Bruns CJ, Holscher AH, Chon SH. Self-Expanding Metal Stents Versus Endoscopic Vacuum Therapy in Anastomotic Leak Treatment After Oncologic Gastroesophageal Surgery. J Gastrointest Surg. 2019 Jan;23(1):67-75. doi: 10.1007/s11605-018-4000-x. Epub 2018 Oct 29.
- Results publication: PubMed 29984413Grimminger PP, Goense L, Gockel I, Bergeat D, Bertheuil N, Chandramohan SM, Chen KN, Chon SH, Denis C, Goh KL, Gronnier C, Liu JF, Meunier B, Nafteux P, Pirchi ED, Schiesser M, Thieme R, Wu A, Wu PC, Buttar N, Chang AC. Diagnosis, assessment, and management of surgical complications following esophagectomy. Ann N Y Acad Sci. 2018 Dec;1434(1):254-273. doi: 10.1111/nyas.13920. Epub 2018 Jul 8.
- Results publication: PubMed 29653446Chon SH, Toex U, Plum PS, Fuchs C, Kleinert R, Bruns C, Goeser T. Successful closure of a gastropulmonary fistula after esophagectomy using the Apollo Overstitch and endoscopic vacuum therapy. Endoscopy. 2018 Jul;50(7):E149-E150. doi: 10.1055/a-0592-6384. Epub 2018 Apr 13. No abstract available.
- Results publication: PubMed 29218673Bludau M, Fuchs HF, Herbold T, Maus MKH, Alakus H, Popp F, Leers JM, Bruns CJ, Holscher AH, Schroder W, Chon SH. Results of endoscopic vacuum-assisted closure device for treatment of upper GI leaks. Surg Endosc. 2018 Apr;32(4):1906-1914. doi: 10.1007/s00464-017-5883-4. Epub 2017 Dec 7.
- Derived from this study: PubMed 37353654Mandarino FV, Barchi A, Leone L, Fanti L, Azzolini F, Viale E, Esposito D, Salmeri N, Puccetti F, Barbieri L, Cossu A, Treppiedi E, Elmore U, Rosati R, Danese S. Endoscopic vacuum therapy versus self-expandable metal stent for treatment of anastomotic leaks < 30 mm following oncologic Ivor-Lewis esophagectomy: a matched case-control study. Surg Endosc. 2023 Sep;37(9):7039-7050. doi: 10.1007/s00464-023-10213-8. Epub 2023 Jun 23.
- Derived from this study: PubMed 34078426Tachezy M, Chon SH, Rieck I, Kantowski M, Christ H, Karstens K, Gebauer F, Goeser T, Rosch T, Izbicki JR, Bruns CJ. Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial. Trials. 2021 Jun 2;22(1):377. doi: 10.1186/s13063-021-05315-4.
- Individual participant dataSharing planned: Undecided
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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.
Seung-Hun Chon, MD principal investigator
University Hospital of Cologne
Michael Tachezy, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf (UKE)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leaks, Anastomotic, run by University Hospital of Cologne at 2 sites 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-Hun Chon, MD (+49221478 4864, seung-hun.chon@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of treatment assessed by EORTC QLQ - OES18 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03962244, which also lists 7 linked publications.
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 29 Apr 2021.