A Phase 1/2 interventional study of Replacement of the esophagus with a decellularized human esophagus graft in Esophageal Stenosis, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 1/2, Interventional, and Other
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.
50 studies on the registry are indexed under Esophageal Stenosis; 11 are open to participants now.
This study's planned enrollment of 24 is close to the median of 24 across 41 interventional studies indexed under Esophageal Stenosis.
Browse Esophageal Stenosis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Related to the transplant procedure
Other: Replacement of the esophagus with a decellularized human esophagus graft
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.
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
Time frame: 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
Time frame: At 12 months after esophageal replacement
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.
Time frame: At 12 months after esophageal replacement
Presence of complete re-epithelialization, and integration into the native esophagus
Assessed by endoscopy
Time frame: 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
Time frame: At 12 months after surgery
Normal bolus transit
Assessed by barium deglutition
Time frame: At 6 months after surgery
Normal bolus transit
Assessed by barium deglutition
Time frame: At 12 months after surgery
Esophageal manometry
Time frame: 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
Time frame: Up to 14 months
Overall survival and Safety of procedure
Patient survival at 12 months regardless of cause of death
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: At 12 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris