Skip to main content
OpenTrials
Completed

NCT Number: NCT02749201

Transmitted Light Tissue Thickness Analysis (TiLTT)

To assess gastric wall thickness using transmitted light intensity.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

About this study

The most common surgical procedure for weight loss is the sleeve gastrectomy. The laparoscopic sleeve gastrectomy (LSG) involves the linear stapling of the stomach using a stapling device [e.g. Echelon (Ethicon Somerset NJ)] fired multiple times along the length of the stomach thereby excising 80-90% of the stomach leaving the patient with a "sleeve" of stomach rather than the normal anatomical pouch. The gastric wall varies in thickness and thus there are a varied staple sizes available for this use. Staple sizes range from 2.0mm-5.0mm in height. In standard surgical practice the surgeon chooses the size of staple cartridge for each subsequent firing based on his experience and estimations about the thickness of the stomach tissue in any given region. The drawback of this technique is that it is highly inaccurate. If the surgeon's estimation is in error, the staple height chosen may be either too tall or too short leading to bleeding or leakage from between the staples or malformed/unformed staples leading to staple line failure. Any of these errors can lead to devastating complications such as hemorrhage, leak, sepsis and death. To date there is no objective way to measure the thickness of the tissue being stapled and thus staple choice relies entirely on surgeon estimation which is inherently inaccurate. The investigators hypothesize that a light source placed in the stomach lumen will transmit light through the gastric wall. The amount of light transmitted, i.e. visible to an imaging device arrayed external to the stomach, will be directly proportionate to the thickness of the stomach. This study will take advantage of the fact that during routine procedures in the sleeve gastrectomy procedure a lighted tube is placed into the gastric lumen via the mouth. This device is called the Gastrisail and has 10 separate LED lights arrayed along its length. This allows for the measurement of transmitted light intensity through the gastric wall at 10 individual locations along the length f the stomach. In addition this study will take advantage of the fact that during standard practice in a sleeve gastrectomy a section of the stomach corresponding to the location of the lights is excised and sent for pathological evaluation. This will allow us to measure the actual thickness of the stomach at 10 points corresponding to he locations of the transmitted light intensity. For this measurement The investigators will use a standardized and validated measurement tool/calipers. Now with two sets of numbers the investigators plan to correlate the degree of transmitted light intensity with actual thickness measurements and thereby reach an algorithm which will allow the transmitted light intensity data alone to predict gastric wall thickness. This will provide the surgeon with an entirely non-invasive objective measure of gastric wall thickness and hopefully improve his/her choice of staple size during these surgical procedures thus improving safety.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has provided informed consent
  • Subject is between the ages of 18 and 80 years of age
  • Subject is scheduled for and undergoes primary sleeve gastrectomy

Exclusion criteria

  • Revisional Bariatric Surgery

Treatment and study plan

Gastrisail

Device

Light Intensity and gastric wall thickness assessment

Primary outcomes

  1. Number of Patients With Transmitted Light Intensity to Gastric Wall Thickness)

    Time frame: intraoperative

    Number of patients with transmitted light intensity to gastric wall thickness between the groups

Sponsors and collaborators

Lead sponsor

Maimonides Medical Center

Other

Collaborators

  • Medtronic

Registry information

Acronym: TiLLT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2016
Registry last updated
Jun 23, 2021

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.

Published trials that share one or more normalized conditions with this study.