Status:
COMPLETED
Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Barrett's Esophagus
Intestinal Dysplasia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
ESD (Endoscopic Sub-mucosal Dissection)is the first-intent method to treat superficial neoplasms of the digestive tract at it allows an en-bloc R0 resection. Following marking of the lesion margins, E...
Eligibility Criteria
Inclusion
- in the esophagus: squamous cell carcinoma (well differentiated G1) or high grade dysplasia or neoplasia on barrett esophagus with high grade dysplasia or adenocarcinoma confirmed by two different pathologists, with only superficial tissue (mucosal invasion (T1m) and no lymph nodes on EUS endoscopy radial and mini probe), larger than 15 mm of diameter, with an extension of less than 10 cm high and less than two thirds of the esophageal circumference
- in the stomach: superficial adenocarcinoma or high grade dysplasia (well differentiated G1) with no depth invasion of the sub mucosa in EUS endoscopy and no lymph nodes according to the recommendations of the Japanese gastric cancer association, and with a diameter of more than 15 mm
- in the colon and the rectum: sessile serrated adenomas, adenomas or superficial adenocarcinoma (well differentiated G1), larger than 15 mm, corresponding to non granular Lateral spreading tumor (NG-LST) or granular (G-LST) with a focal Kudo V zone in the lesion, with a circumferential extension of less than two thirds and with only a superficial extension (no sub mucosal invasion and no lymph nodes in EUS endoscopy of the rectum).
- Consent form signed
- Anesthesiology risk limited with ASA score 1 or 2
- Patients over 18 years old
- Affiliation to social safety system
Exclusion
- other lesions of the digestive tract
- high anesthetic risk (ASA score \> 2)
- previous treatment of the lesion (radiotherapy, endoscopy, surgery, chemotherapy…)
- other malignant disease locally advanced or with metastasis
- hemostasis disorders
- pregnancy or breast feeding
- participation in another clinical trial
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01913223
Start Date
June 1 2012
End Date
July 1 2014
Last Update
May 28 2019
Active Locations (1)
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1
Hôpital Edouard Herriot
Lyon, France