Dilatation of AnastomosisNCT03264027
Carbon Dioxide Versus Air Insufflation for the Application of Argon Plasma to Reduce the Gastrojejunal Anastomosis
A study testing Carbon dioxide, Ambient air and Argon fulguration in people with Dilatation of Anastomosis and Bypass Complication, run by Kaiser Clinic and Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dilatation of Anastomosis, Bypass Complication, Obesity
- What is being tested?
- Carbon dioxide, Ambient air and Argon fulguration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jan 2017to 12 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Kaiser Clinic and Day Hospital
São José Do Rio Prêto, São Paulo, 15015-110
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Dilatation of Anastomosis, Bypass Complication, Obesity
- Being tested
- Carbon dioxide, Ambient air, Argon fulguration
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxideDrug
Also called Carbon dioxide insufflation
Carbon dioxide will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.
Ambient airDrug
Also called Ambient air insuflattion
Ambient air will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.
Argon fulgurationDrug
Also called Argon
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).
| Study group | Role | What they receive |
|---|---|---|
| Carbon dioxide | Experimental | 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. Receives: Drug: Carbon dioxide; Drug: Argon fulguration |
| Ambient air | Active comparator | 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. Receives: Drug: Ambient air; Drug: Argon fulguration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Visual Analogue Scale
A visual scale to assess self-reported pain going from 0 to 10.
Measured: 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.
Secondary outcomes (2)
Change in diameter of the gastrojejunal anastomosis
Analysis and measurement in millimeters of the anastomosis will be achieved using Raptor foreign body forceps (Endoscopy Group US, Inc., Mentor - Ohio, USA).
Measured: Before surgery, and after eight weeks of the first endoscopic session.
Weight reduction
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
Measured: Before surgery, and after eight weeks of the first endoscopic session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start6 Jan 2017
- Primary completion12 Jan 2020
- Study completion12 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dilatation of AnastomosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Clinic and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Gustavo de Quadros, MD, Kaiser Clinic and Hospital
- Investigators
- Luiz G Quadros, MD, Principal investigator, Kaiser Clinic and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264027
- Sponsor's protocol ID
- kaiserargongjanastomosis
- Status last verified
- Aug 2022
- First submitted
- 3 Jul 2017
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25005812
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03264027
- Acronym / sponsor ID
- kaiserargongjanastomosis
- Conditions
- Dilatation of Anastomosis, Bypass Complication, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kaiser Clinic and HospitalUniversity, hospital or other
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 12 Jan 2020 (actual)
- Study completion
- 12 Jan 2020 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon dioxide | Experimental | Drug: Carbon dioxide, Drug: Argon fulgurationArgon 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. |
| Ambient air | Active comparator | Drug: Ambient air, Drug: Argon fulgurationArgon 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon dioxideAlso: Carbon dioxide insufflationCarbon dioxide will be used as an insufflating gas during argon fulguration of the dilatated anastomosis. | Drug | Carbon dioxide |
| Ambient airAlso: Ambient air insuflattionAmbient air will be used as an insufflating gas during argon fulguration of the dilatated anastomosis. | Drug | Ambient air |
| Argon fulgurationAlso: ArgonThe 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). | Drug | Ambient air, Carbon dioxide |
Primary outcome
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.
2 secondary outcomes
Change in diameter of the gastrojejunal anastomosis
Time frame: Before surgery, and after eight weeks of the first endoscopic session.
Weight reduction
Time frame: Before surgery, and after eight weeks of the first endoscopic session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Background: PubMed 25005812Baretta 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz G Quadros, MD principal investigator
Kaiser Clinic and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon dioxide, Ambient air and Argon fulguration in people with Dilatation of Anastomosis and Bypass Complication, run by Kaiser Clinic and Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03264027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.