Clinical trial: Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial (NCT01913223)

Eligibility criteria:
Inclusion Criteria:

          -  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 Criteria:

          -  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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment