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Carbon Dioxide Versus Air Insufflation for the Application of Argon Plasma to Reduce the Gastrojejunal Anastomosis

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ClinicalTrials.gov Identifier: NCT03264027
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Luiz Gustavo de Quadros, MD, Kaiser Clinic and Hospital

Tracking Information
First Submitted Date  ICMJE July 3, 2017
First Posted Date  ICMJE August 28, 2017
Last Update Posted Date May 28, 2019
Actual Study Start Date  ICMJE January 6, 2017
Estimated Primary Completion Date January 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2017)
Change in Pain Visual Analogue Scale [ Time Frame: Before surgery, and after eight weeks of the first endoscopic session. The outcome will be the substraction of the initial value and the final value of pain. ]
A visual scale to assess self-reported pain going from 0 to 10.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2017)
  • Change in diameter of the gastrojejunal anastomosis [ Time Frame: Before surgery, and after eight weeks of the first endoscopic session. ]
    Analysis and measurement in millimeters of the anastomosis will be achieved using Raptor foreign body forceps (Endoscopy Group US, Inc., Mentor - Ohio, USA).
  • Weight reduction [ Time Frame: Before surgery, and after eight weeks of the first endoscopic session. ]
    The final weight measured in kilograms after eight weeks of the initial surgery will be subtracted from the weight at the start of the trial
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carbon Dioxide Versus Air Insufflation for the Application of Argon Plasma to Reduce the Gastrojejunal Anastomosis
Official Title  ICMJE A Multicenter Randomized Clinical Trial of Carbon Dioxide (CO2) Versus Air Insufflation for the Application of Argon Plasma to Reduce the Gastrojejunal Anastomosis in Individuals With Weight Regain After Bypass Surgery.
Brief Summary The objective of this randomized clinical trial is to compare pain levels during and after insufflation with carbon dioxide or in subjects that will undergo endoscopic fulguration with argon to reduce the diameter of the gastrojejunal anastomosis. The investigators hypothesize that carbon dioxide will be superior in causing less pain and leading to less discomfort.
Detailed Description

Laparoscopic gastric bypass surgery is one of the strategies oriented towards weight reduction in obese patients. Although in the short term it has a high degree of success, weight regain is common in the long term, in part due to the dilatation of the anastomosis that allows food to pass without barriers and hinders the purpose of bypass surgery. Fulguration with argon is an endoscopic technique that reduces the diameter of the anastomosis, offering resistance to food passage and improving patient outcomes.

Although carbon dioxide is the current standard for laparoscopic surgery, its use for fulguration with argon as compared to ambient air has not been investigated in the setting of the stenosis of a dilated anastomosis following gastric bypass surgery. stenosis. Therefore, to investigate pain during and after this procedure, investigators will conduct a randomized clinical trial comparing carbon dioxide and ambient air.

The secondary aims will be to measure the diameter of the gastrojejunal anastomosis during three endoscopic sessions and in a final control examination eight weeks after the third session; to determine whether the patient loses weight or not by the final control objective after three sessions of endoscopic fulguration with argon; to analyze if the method employed is able to reduce body weight to the minimum weight achieved after bariatric surgery;and to investigate whether there is a correlation between the percentage reduction in anastomotic diameter and the percentage loss of regained weight.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Both the participant and the outcome assessor will be blinded to the study intervention.
Primary Purpose: Treatment
Condition  ICMJE
  • Dilatation of Anastomosis
  • Bypass Complication
  • Obesity
Intervention  ICMJE
  • Drug: Carbon dioxide
    Carbon dioxide will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.
    Other Name: Carbon dioxide insufflation
  • Drug: Ambient air
    Ambient air will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.
    Other Name: Ambient air insuflattion
  • Drug: Argon fulguration
    The dilatated anastomosis from the gastric bypass surgery will be reduced in diameter using fulguration with argon. Patient in both groups will be placed in the left lateral decubitus position, with anesthesia being performed exclusively using propofol; adequate cardiopulmonary monitoring will be carried out during the entire procedure. After sedation, endoscopy will be performed with an Olympus CV-180 endoscope (Olympus, Tokyo, Japan) and analysis and measurement of the anastomosis will be achieved using Raptor foreign body forceps (Endoscopy Group US, Inc., Mentor - Ohio, USA). The images will be transferred to an Olympus EvisExera II processor connected to a computer with the ZScan 5 program (Goiânia, GO, Brazil).
    Other Name: Argon
Study Arms  ICMJE
  • Experimental: Carbon dioxide
    Argon fulguration will be performed using CO2 for insufflation. After using a disposable endoscopic catheter, argon plasma (Argon 2) (MAE, Ribeirão Preto, Brazil) will be applied in a 1-cm band around the entire circumference of the gastrojejunal anastomosis at an intensity of 90 W and a flow rate of 2 L/min.
    Interventions:
    • Drug: Carbon dioxide
    • Drug: Argon fulguration
  • Active Comparator: Ambient air
    Argon fulguration will be performed using ambient air for insufflation. After using a disposable endoscopic catheter, argon plasma (Argon 2) (MAE, Ribeirão Preto, Brazil) will be applied in a 1-cm band around the entire circumference of the gastrojejunal anastomosis at an intensity of 90 W and a flow rate of 2 L/min.
    Interventions:
    • Drug: Ambient air
    • Drug: Argon fulguration
Publications * Baretta GA, Alhinho HC, Matias JE, Marchesini JB, de Lima JH, Empinotti C, Campos JM. Argon plasma coagulation of gastrojejunal anastomosis for weight regain after gastric bypass. Obes Surg. 2015 Jan;25(1):72-9. doi: 10.1007/s11695-014-1363-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 12, 2020
Estimated Primary Completion Date January 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Regain of at least 10.0% of the minimum weight reached after the gastric bypass;
  • Ability to understand study procedures;
  • Signed the informed written consent form;
  • Possible to complete all the stages of the study.

Exclusion Criteria:

  • Presence of very tight restrictive ring preventing the advancement of the endoscopy device;
  • Stenosis of the anastomosis preventing the progression of the endoscopy device before the end of the three endoscopic sessions;
  • History of liver diseases such as cirrhosis or chronic active hepatitis;
  • Patients who required anticoagulant therapy with the exception of antiplatelet agents;
  • Pregnant women or those intending to become pregnant within 12 months after fulguration with argon;
  • Participant in another ongoing clinical research;
  • Recent history of neoplasia (less than 5 years);
  • Alcoholism or drug use;
  • HIV positive;
  • Unbalanced or uncontrollable psychiatric disorders;
  • Anemia or severe nutritional deficiencies;
  • Allergy to anesthetic compounds;
  • Impossibility to return within defined periods for consultations and endoscopic sessions of fulguration with argon;
  • Inability to follow nutritional guidelines after each endoscopic session;
  • Inability to understand study procedures;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Luiz G Quadros, MD 5517981388737 gustavo_quadros@hotmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03264027
Other Study ID Numbers  ICMJE kaiserargongjanastomosis
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Luiz Gustavo de Quadros, MD, Kaiser Clinic and Hospital
Study Sponsor  ICMJE Kaiser Clinic and Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luiz G Quadros, MD Kaiser Clinic and Hospital
PRS Account Kaiser Clinic and Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP