Esophageal StenosisPhase 1/2ESOGRAFTNCT06662370
Esophageal Replacement With a Decellularized Human Esophagus Graft
A Phase 1/2 study testing Replacement of the esophagus with a decellularized human esophagus graft in people with Esophageal Stenosis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The aim of the study is to analyze over a 12 month-period, the safety and the efficacy of a circumferentiel oesophageal replacement of the esophagus by a decelularized human esophagus, in 24 patient with a short esophageal stenosis refractory to endoscopic dilatations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esophageal Stenosis
- What is being tested?
- Replacement of the esophagus with a decellularized human esophagus graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Jan 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 65
- Caustic, traumatic, anastomotic, post-operative, radiation-induced or post-endoscopic (mucosal resection, submucosal dissection) benign esophageal stricture refractory to endoscopic dilatation.
- For women: effective contraception for the entire duration of the study (from signature of consent to end of follow-up)
- Affiliated or beneficiary of a social security scheme.
- Free written consent signed by the participant and the investigator.
Who cannot join
- Weight loss > 10% of body weight over last 3 months
- Stenosis > 5 cm in length
- Multiple strictures
- Esophageal mouth stenosis
- Anterior surgery close to the operative zone
- Complete anterior omentectomy
Show all 24Show fewer
- Tumour stenosis or progressive tumour pathology
- Non-stabilized psychiatric disorders
- Participation in another interventional study
- Pregnant or breast-feeding women
- Women of childbearing age without effective contraceptive measures:
- All women of childbearing age must have a negative pregnancy test prior to treatment and must agree to maintain highly effective contraception using contraceptive measures from the date of consent until 12 months due to the risks associated with anesthesia during endoscopy
- Uncontrolled sepsis
- Related to the transplant procedure
- ASA score ≥ 3,
- Severe respiratory insufficiency (FEV1 < 1 L),
- Decompensated hepatic cirrhosis or presence of esophageal varices,
- Chronic renal insufficiency (creatinine > 1.25 N),
- Myocardial infarction less than 6 months old or progressive heart disease,
- WHO general condition > 2,
- Weight loss >20% not recovered after renutrition.
- Contraindication to general anaesthesia, analgesics and antibiotics.
- Conditions requiring long-term immunosuppressive or corticosteroid treatment.
- Patients under curatorship or guardianship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Remplacement de l'œsophage Par Une Greffe d'œsophage Humain décellularisé
The aim of the study is to analyze over a 12 month-period, the safety and the efficacy of a circumferentiel oesophageal replacement of the esophagus by a decelularized human esophagus, in 24 patient with a short esophageal stenosis refractory to endoscopic dilatations.
- Conditions
- Esophageal Stenosis
- Being tested
- Replacement of the esophagus with a decellularized human esophagus graft
- Keywords
- Tissue engineering, Esophageal replacement, Esophageal stenosis, Caustic injury, Radiotherapy, Anastomotic stenosis, Esophageal stent
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replacement of the esophagus with a decellularized human esophagus graftOther
The Decellularized Human Esophagus (DHE) will be surgically implanted under general anesthesia via right or left thoracotomy or cervicotomy, depending on the location of the stenosis, to replace the esophageal defect created by resection of the stenosis. An omentoplasty is performed laparoscopically beforehand to provide secondary coverage of the graft area. A temporary esophageal stent is placed endoscopically to cover the DHE and the two anastomoses for a period of 3 months, to prevent the development of an anastomotic fistula and stenosis of the graft area.
| Study group | Role | What they receive |
|---|---|---|
| Esophagus replacement | Experimental | Not described Receives: Other: Replacement of the esophagus with a decellularized human esophagus graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity/mortality
Safety criterion : morbidity/mortality defined by :
Refractory stenosis, leaking, sepsis, stent migration, death, complete rupture of anastomoses, uncontrolled mediastinal sepsis requiring removal of the substitute and/or esophagectomy, delamination of the tissue graft, tracheobronchial wound intra-operatively or oesotracheal fistula postoperatively, upper digestive obstruction after stent removal preventing any attempt to dilate the graft zone, or upper digestive obstruction after stent removal preventing any attempt to dilate the graft zone
Measured: At 3 months after surgery
Nutritional autonomy
Efficacy criterion: nutritional autonomy at 12 months after esophageal replacement defined as stable weight with exclusive oral nutrition and without esophageal stenting for at least 3 months, and without persistent symptomatic scar stenosis after 5 endoscopic dilatation sessions
Measured: At 12 months after esophageal replacement
Secondary outcomes (14)
Safety of the procedure
The morbidity and mortality of the procedure will be defined by the occurrence of a complication such as leakage, sepsis, recurrent paralysis, esophageal stricture refractory to dilatation, anastomotic fistula, sepsis, esophageal perforation, cardio-respiratory complication (pneumopathy, pleural effusion, pulmonary embolism, AC/FA, infarction), death, tissue graft disintegration, postoperative tracheobronchial wound or oesotracheal fistula, or upper digestive obstruction after stent removal preventing any attempt to dilate the graft zone), for 12 months from the date of surgery.
Measured: At 12 months after esophageal replacement
Presence of complete re-epithelialization, and integration into the native esophagus
Assessed by endoscopy
Measured: At 3 months after surgery
Presence of complete re-epithelialization, and integration into the native esophagus
Assessed by CT scan with gel ingestion and intravenous contrast injection
Measured: At 12 months after surgery
Normal bolus transit
Assessed by barium deglutition
Measured: At 6 months after surgery
Normal bolus transit
Assessed by barium deglutition
Measured: At 12 months after surgery
Esophageal manometry
Measured: At 12 months after surgery
Percentage of procedures interrupted for logistical reasons
Logistical reasons are defined as :
- An incident during transport from the Human Tissue Bank to the operating room, resulting in the loss of the graft
- Accidental rupture of graft packaging, with risk of loss of sterility
- An incident occurring during the graft thawing procedure
Measured: Up to 14 months
Overall survival and Safety of procedure
Patient survival at 12 months regardless of cause of death
Measured: At 12 months after surgery
Impact of procedure on quality of life
EORTC QLQ-OG25 module Score varying between 25 and 100, the higher the score the more severe the symptoms
Measured: At 6 months after surgery
Impact of procedure on quality of life
EORTC QLQ-OG25 module Score varying between 25 and 100, the higher the score the more severe the symptoms
Measured: At 12 months after surgery
Impact of procedure on quality of life
SF12V2 modules It is a 12 items score varying from to 0 to 100. The higher the score, the better the quality of life
Measured: At 6 months after surgery
Impact of procedure on quality of life
SF12V2 modules It is a 12 items score varying from to 0 to 100. The higher the score, the better the quality of life
Measured: At 12 months after surgery
Estimating the cost of the procedure for one patient
-Direct medical costs of the procedure: constitution (tissue engineering), storage and transport of the esophageal stent, hospital stay for graft surgery, emergency room visits, scheduled or unscheduled re-hospitalizations, follow-up in hospital consultations, scheduled or unscheduled outpatient physician visits, outpatient biological procedures, outpatient medical imaging, drug prescriptions, transport and coordination time by the expert team.
Measured: At 12 months
Estimating the cost of the procedure for target population
-Simulation using trial data of costs for all patients with esophageal transplant indication
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StenosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, non-comparative, phase I/II, single-arm, multicenter trial
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662370
- Sponsor's protocol ID
- APHP220793
- Acronym
- ESOGRAFT
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remplacement de l'œsophage Par Une Greffe d'œsophage Humain décellularisé
- ClinicalTrials.gov ID
- NCT06662370
- Acronym / sponsor ID
- ESOGRAFT / APHP220793
- Conditions
- Esophageal Stenosis
- Keywords
- Tissue engineering, Esophageal replacement, Esophageal stenosis, Caustic injury, Radiotherapy, Anastomotic stenosis, Esophageal stent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 28 Oct 2024 (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.
The aim of the study is to analyze over a 12 month-period, the safety and the efficacy of a circumferentiel oesophageal replacement of the esophagus by a decelularized human esophagus, in 24 patient with a short esophageal stenosis refractory to endoscopic dilatations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, non-comparative, phase I/II, single-arm, multicenter trial
| Arm | Type | Receives |
|---|---|---|
| Esophagus replacement | Experimental | Other: Replacement of the esophagus with a decellularized human esophagus graft |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 to 65
- Caustic, traumatic, anastomotic, post-operative, radiation-induced or post-endoscopic (mucosal resection, submucosal dissection) benign esophageal stricture refractory to endoscopic dilatation.
- For women: effective contraception for the entire duration of the study (from signature of consent to end of follow-up)
- Affiliated or beneficiary of a social security scheme.
- Free written consent signed by the participant and the investigator.
Key exclusion criteria (24 listed)
- Weight loss > 10% of body weight over last 3 months
- Stenosis > 5 cm in length
- Multiple strictures
- Esophageal mouth stenosis
- Anterior surgery close to the operative zone
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 |
|---|---|---|
| Replacement of the esophagus with a decellularized human esophagus graftThe Decellularized Human Esophagus (DHE) will be surgically implanted under general anesthesia via right or left thoracotomy or cervicotomy, depending on the location of the stenosis, to replace the esophageal defect created by resection of the stenosis. An omentoplasty is performed laparoscopically beforehand to provide secondary coverage of the graft area. A temporary esophageal stent is placed endoscopically to cover the DHE and the two anastomoses for a period of 3 months, to prevent the development of an anastomotic fistula and stenosis of the graft area. | Other | Esophagus replacement |
Primary outcome
Morbidity/mortality
Time frame: At 3 months after surgery
Safety criterion : morbidity/mortality defined by : Refractory stenosis, leaking, sepsis, stent migration, death, complete rupture of anastomoses, uncontrolled mediastinal sepsis requiring removal of the substitute and/or esophagectomy, delamination of the tissue graft, tracheobronchial wound intra-operatively or oesotracheal fistula postoperatively, upper digestive obstruction after stent removal preventing any attempt to dilate the graft zone, or upper digestive obstruction after stent removal preventing any attempt to dilate the graft zone
Nutritional autonomy
Time frame: At 12 months after esophageal replacement
Efficacy criterion: nutritional autonomy at 12 months after esophageal replacement defined as stable weight with exclusive oral nutrition and without esophageal stenting for at least 3 months, and without persistent symptomatic scar stenosis after 5 endoscopic dilatation sessions
14 secondary outcomes
Safety of the procedure
Time frame: At 12 months after esophageal replacement
Presence of complete re-epithelialization, and integration into the native esophagus
Time frame: At 3 months after surgery
Presence of complete re-epithelialization, and integration into the native esophagus
Time frame: At 12 months after surgery
Normal bolus transit
Time frame: At 6 months after surgery
Normal bolus transit
Time frame: At 12 months after surgery
Esophageal manometry
Time frame: At 12 months after surgery
Percentage of procedures interrupted for logistical reasons
Time frame: Up to 14 months
Overall survival and Safety of procedure
Time frame: At 12 months after surgery
Impact of procedure on quality of life
Time frame: At 6 months after surgery
Impact of procedure on quality of life
Time frame: At 12 months after surgery
Impact of procedure on quality of life
Time frame: At 6 months after surgery
Impact of procedure on quality of life
Time frame: At 12 months after surgery
Estimating the cost of the procedure for one patient
Time frame: At 12 months
Estimating the cost of the procedure for target population
Time frame: At 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Esophageal Stenosis
Enrolling by invitation
Adipose-derived Stem Cells in Treatment of Esophageal Strictures
Esophageal Stenosis Acquired
Recruiting
Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
Dysphagia, Esophageal Stricture
Not yet recruiting
Treatment of Dysphagia in Patients With Dystrophic Epidermolysis Bullosa With Budesonide: a Retrospective Bicentric Study Nice - Paris St Louis / Necker (EBUDE Study)
Recessive Dystrophic Epidermolysis Bullosa, Dysphagia
Not yet recruiting
Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.
Esophageal Stricture
Recruiting
Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study
Esophageal Atresia With Tracheo-esophageal Fistula, Esophageal Atresia
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Replacement of the esophagus with a decellularized human esophagus graft in people with Esophageal Stenosis, run by Assistance Publique - Hôpitaux de Paris.
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 5 inclusion and 24 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: opening soon, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Cattan, MD PhD (+33142499116 ext. +33, pierre.cattan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity/mortality (time frame: At 3 months after surgery). The study lists 2 primary outcomes in all. 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 28 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.