Esophageal Replacement With a Decellularized Human Esophagus Graft

Phase 2Not Yet RecruitingNCT06662370

Assistance Publique - Hôpitaux de Paris24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Esophageal Stenosis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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. 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Pierre Cattan, MD PhD

CONTACT

+33142499116 pierre.cattan@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

+33142499742 jerome.lambert@u-paris.fr

Data from ClinicalTrials.gov

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