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NCT Number: NCT01913223

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

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, ESD comprises 3 steps: 1) liquid injection into the sub-mucosal space 2) circumferential (complete or partial) incision and 3) dissection of the submucosa. Several tools are necessary to perform ESD with the standard technique. Development of water jet with bi functional (injection and cutting) catheter allows time and significant reduction of perforation risk (due to multiple changes of instruments). For this purpose, Nestis introduced the Enki 2 pulsed jet technology with high pressure system to inject efficiently and at any time viscous solutions in direct viewing and retroflexion. Preliminary pig studies indicate that injection of glycerol, hyaluronate and hydroxyethlstarch with Enki 2 are possible. In addition, preclinical studies on living pig colon models using saline solutions have demonstrated that perforation rates and operating times are significantly reduced compared to a standard electrosurgical knife. The present clinical study is being performed to confirm this system capability to perform ESD in humans.

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Dysplasia Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Dysplasia Intestinal Neoplasms Neoplasms Neoplasms by Site Precancerous Conditions Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Edouard Herriot

Lyon, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Nestis® jet injector system with a bi-functional catheter

Device

Primary outcomes

  1. Safety outcome

    Time frame: At 1 month

    Safety is measured in term of perforation rate and bleeding rate with immediate complication or delayed one after the procedure, at one month complications are not linked to the ESD procedure

Secondary outcomes

  1. Effectiveness of the procedure in terms of complete neoplasia resections

    Time frame: less than one month to get the pathology examination report

    Procedure is successful when the resection is complete with no residual tissue on the margins in depth and in the lateral part of the lesions.

  2. Effectiveness of the procedure in terms of complete neoplasia resections

    Time frame: three month

    no macroscopic nor microscopic local recurrence during follow up endoscopy

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial.

Acronym: NESTIS

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 1, 2013
Registry last updated
May 28, 2019

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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