Esophageal Replacement With a Decellularized Human Esophagus Graft

Phase 1

Not yet recruiting

• Conditions: Esophageal Stenosis

• Registration Number: NCT06662370
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Study Start: 2024-11-01
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Morbidity/mortality	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	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

Secondary Outcome Measures

Name	Time	Method
Safety of the procedure	At 12 months after esophageal replacement	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.
Presence of complete re-epithelialization, and integration into the native esophagus	At 12 months after surgery	Assessed by CT scan with gel ingestion and intravenous contrast injection
Normal bolus transit	At 12 months after surgery	Assessed by barium deglutition
Esophageal manometry	At 12 months after surgery
Percentage of procedures interrupted for logistical reasons	Up to 14 months	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
Overall survival and Safety of procedure	At 12 months after surgery	Patient survival at 12 months regardless of cause of death
Impact of procedure on quality of life	At 12 months after surgery	SF12V2 modules It is a 12 items score varying from to 0 to 100. The higher the score, the better the quality of life
Estimating the cost of the procedure for one patient	At 12 months	-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.
Estimating the cost of the procedure for target population	At 12 months	-Simulation using trial data of costs for all patients with esophageal transplant indication