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NCT Number: NCT06662370

Esophageal Replacement With a Decellularized Human Esophagus Graft

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.

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Key information

Conditions

Esophageal Stenosis Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Replacement of the esophagus with a decellularized human esophagus graft

Other

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Safety of the procedure

    Time frame: 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.

  2. Presence of complete re-epithelialization, and integration into the native esophagus

    Time frame: At 3 months after surgery

    Assessed by endoscopy

  3. Presence of complete re-epithelialization, and integration into the native esophagus

    Time frame: At 12 months after surgery

    Assessed by CT scan with gel ingestion and intravenous contrast injection

  4. Normal bolus transit

    Time frame: At 6 months after surgery

    Assessed by barium deglutition

  5. Normal bolus transit

    Time frame: At 12 months after surgery

    Assessed by barium deglutition

  6. Esophageal manometry

    Time frame: At 12 months after surgery

  7. Percentage of procedures interrupted for logistical reasons

    Time frame: 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

  8. Overall survival and Safety of procedure

    Time frame: At 12 months after surgery

    Patient survival at 12 months regardless of cause of death

  9. Impact of procedure on quality of life

    Time frame: At 6 months after surgery

    EORTC QLQ-OG25 module Score varying between 25 and 100, the higher the score the more severe the symptoms

  10. Impact of procedure on quality of life

    Time frame: At 12 months after surgery

    EORTC QLQ-OG25 module Score varying between 25 and 100, the higher the score the more severe the symptoms

  11. Impact of procedure on quality of life

    Time frame: At 6 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

  12. Impact of procedure on quality of life

    Time frame: 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

  13. Estimating the cost of the procedure for one patient

    Time frame: 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.

  14. Estimating the cost of the procedure for target population

    Time frame: At 12 months

    -Simulation using trial data of costs for all patients with esophageal transplant indication

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Lambert, MD PhD

CONTACT

[email protected]

+33142499742 ext. +33

Pierre Cattan, MD PhD

CONTACT

[email protected]

+33142499116 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Remplacement de l'œsophage Par Une Greffe d'œsophage Humain décellularisé

Acronym: ESOGRAFT

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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