Bile RefluxNCT03097887
Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures
A study testing Omega Loop Gastric Bypass, Bilitec 2000™ and V-Loc in people with Bile Reflux, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does it increase after the procedure? Second, does performing an OLGB with or without anti-reflux sutures make a difference in (biliary) reflux exposures of the distal esophagus?… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Bile Reflux
- What is being tested?
- Omega Loop Gastric Bypass, Bilitec 2000™ and V-Loc
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2019to 1 Jul 2021
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 70 years
- Body Mass Index ≥ 35.0 kg/m2
- Exclusion of psychological, endocrinological and anesthesiological contraindications
- Willingness to be assigned to either of the two groups
- Follow-up anticipation
- Willingness to attend all follow-up visits
- Written informed consent
Who cannot join
- recent or ongoing cardiovascular event within the last 6 months (myocardial infarction, acute coronary syndrome, angioplasty or coronary bypass operation, insult),
- pulmonary embolism or thrombophlebitis within the last 6 months, other bariatric procedures, e.g. gastric banding, Sleeve Gastrectomy, etc., cancer of various origins (exceptions: basal cell carcinoma or carcinoma in situ, disease-free over the last 5 years),
- significant anemia or coagulopathy,
- serum creatinin ≥ 1.5 mg/dl.,
- serum bilirubin or phosphatase elevated or ALT above 3 times the upper limit, stomach, biliopancreatic operations, splenectomy or colon resections, gastric or duodenal ulcer within the last 6 months,
- intraabdominal sepsis (except uncomplicated appendicitis or diverticulitis over 6 months prior to the study),
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- organ transplantations,
- anamnestic HIV infection, active TBC, active malaria, chronic Hepatitis B or C, liver cirrhosis,
- alcohol or drug addiction (except caffeine, nicotine) in history,
- acute psychiatric disease interfering with the proposed trial,
- other chronic disease which might interfere with the participation.
- Also, patients who are pregnant or plan a pregnancy within the following two years as well as patients who have been included in another study, will be excluded.
- Note: Exclusion can be performed by a study coordinator at any time.
- Hiatal hernia is not considered an exclusion criterion in this study.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna
Vienna, State of Vienna, 1090
Daniel Moritz Felsenreich, Dr., 00436767016111 ext. 00436767016111, moritz.felsenreich@meduniwien.ac.at
Daniel Moritz Felsenreich, 00436767016111 ext. 00436767016111, moritz.felsenreich@meduniwien.ac.at
About this study
Official title: Prospective, Randomized, Controlled Trial of Omega Loop Gastric Bypass With and Without Anti-reflux Sutures - a Pilot Study
This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does it increase after the procedure? Second, does performing an OLGB with or without anti-reflux sutures make a difference in (biliary) reflux exposures of the distal esophagus? To answer these questions the investigators plan to perform a randomized, controlled trial involving two groups. Group A will undergo an OLGB without anti-reflux sutures and consists of 50 patients. Group B will receive an OLGB with anti-reflux sutures and also consists of 50 patients.
Gastroscopic evaluation for inflammation and reflux will be performed before and one year after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™. Furthermore, the study will be blinded to the patient. Long-term weight loss, the resolution of comorbidities and the incidence of surgical complications will serve as secondary endpoints. Follow-ups will be performed at 3, 6, and 12 months postoperatively to assess all primary and secondary goals.
Read the detailed description
Obesity, and especially its comorbidities, has unarguably become the number one threat to human health in the modern world. Western lifestyle leads to an increased prevalence and thus to a higher mortality (i.e. due to cardiovascular diseases).
The positive effects of gastric bypass surgery on excess weight loss and comorbidity resolution are well-known. In contrast to the standard laparoscopic Roux-en-Y Gastric Bypass (RYGB), a newer method, the laparoscopic Omega Loop Gastric Bypass (OLGB), has emerged over the past years. It is believed to be the simpler method involving only one anastomosis (instead of two) and therefore potentially reducing morbidity and mortality whilst maintaining comparable excess weight loss. However, since this new type of gastric bypass is similar to the former Billroth II resection (BII), the carcinoma risk is a concern. The OLGB is different from the BII resection in many ways. For instance, it involves creating an approximately 10 cm long narrow gastric pouch which could prevent the suspected underlying pathogenetic mechanism: biliary reflux to the gastric tube and subsequently to the esophagus. Biliary reflux is suspected to stimulate squamous esophageal cells and Barrett's epithelial cells to produce inflammatory mediators and therefore cause oxidative stress, DNA damage and apoptosis which might lead to adenocarcinoma.
Worldwide, there are currently two different ways to perform an OLGB: with or without anti-reflux sutures, which involve sewing the biliopancreatic limb to the staple line of the pouch using V-Loc (non-absorbable) moving upwards as far as easily possible without creating any tension.
This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does it increase after the procedure? Second, does performing an OLGB with or without anti-reflux sutures make a difference in (biliary) reflux exposures of the distal esophagus?
- Conditions
- Bile Reflux
- Being tested
- Omega Loop Gastric Bypass, Bilitec 2000™, V-Loc
- Keywords
- Omega Loop Gastric Bypass, Reflux, Mini Gastric Bypass
- Medical subject headings
- Bile Reflux, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega Loop Gastric BypassProcedure or surgery
Also called Mini Gastric Bypass, Single Anastomosis Gastric Bypass
Bariatric/metabolic surgical procedure
Bilitec 2000™Device
The Bilitec 2000™ device will be used to measure the intensity of biliary reflux in the pouch.
V-LocDevice
Sewing device to perform the anti-reflux sutures.
| Study group | Role | What they receive |
|---|---|---|
| Anti-reflux sutures | Active comparator | Omega Loop Gastric Bypass with anti-reflux sutures using V-Loc sewing device. Biliary reflux measured using Bilitec 2000™. Receives: Procedure: Omega Loop Gastric Bypass; Device: Bilitec 2000™; Device: V-Loc |
| No anti-reflux sutures | Active comparator | Omega Loop Gastric Bypass without anti-reflux sutures. Biliary reflux measured using Bilitec 2000™. Receives: Procedure: Omega Loop Gastric Bypass; Device: Bilitec 2000™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bile Reflux
The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Biliary exposure will therefore be assessed before and 12 months after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™.
Measured: 1 year
Bile Reflux
The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Extensive biopsies of the gastric pouch and gastroesophageal junction will be taken to prove histological changes due to biliary reflux.
Measured: 1 year
Secondary outcomes (9)
Inflammation
Assessing inflammation before and 12 months after surgery using gastroscopy with biopsy.
Measured: 1 year
Weight loss
Measuring excess weight loss (EWL), to reveal any changes in patients' weight
Measured: 1 year
BMI loss
Excess BMI loss (EBMIL), to reveal any changes in patients' BMI
Measured: 1 year
Complications by point in time/stage
Early postoperative complications (occurring within 30 days) Late postoperative complications (occurring after 30 days)
Measured: 1 year
Complications by severity
Moderate complications (not requiring additional surgical intervention) Severe complications (requiring surgical intervention)
Measured: 1 year
Resolution of hyperlipidemia
Collecting evidence for the resolution of hyperlipidemia
Measured: 1 year
Resolution of hypertension
Collecting evidence for the resolution of hypertension
Measured: 1 year
Resolution of diabetes
Collecting evidence for the resolution of diabetes
Measured: 1 year
Resolution of sleep apnea
Collecting evidence for the resolution of sleep apnea
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Oct 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile RefluxStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moritz Felsenreich, Medical University of Vienna
- Investigators
- Gerhard Prager, Univ. Prof., Study director, Vienna Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097887
- Sponsor's protocol ID
- 1640/2016
- Status last verified
- Sep 2020
- First submitted
- 21 Mar 2017
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Analysis will be performed on anonymized data only. A list cross-linking the patient number to the name will be kept secure and is only available to the principal researcher. Written informed consent will be kept for 15 years.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Trial of Omega Loop Gastric Bypass With and Without Anti-reflux Sutures - a Pilot Study
- ClinicalTrials.gov ID
- NCT03097887
- Acronym / sponsor ID
- 1640/2016
- Conditions
- Bile Reflux
- Keywords
- Omega Loop Gastric Bypass, Reflux, Mini Gastric Bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 31 Mar 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.
This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does it increase after the procedure? Second, does performing an OLGB with or without anti-reflux sutures make a difference in (biliary) reflux exposures of the distal esophagus? To answer these questions the investigators plan to perform a randomized, controlled trial involving two groups. Group A will undergo an OLGB without anti-reflux sutures and consists of 50 patients. Group B will receive an OLGB with anti-reflux sutures and also consists of 50 patients.
Gastroscopic evaluation for inflammation and reflux will be performed before and one year after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™. Furthermore, the study will be blinded to the patient. Long-term weight loss, the resolution of comorbidities and the incidence of surgical complications will serve as secondary endpoints. Follow-ups will be performed at 3, 6, and 12 months postoperatively to assess all primary and secondary goals.
Detailed description
Obesity, and especially its comorbidities, has unarguably become the number one threat to human health in the modern world. Western lifestyle leads to an increased prevalence and thus to a higher mortality (i.e. due to cardiovascular diseases).
The positive effects of gastric bypass surgery on excess weight loss and comorbidity resolution are well-known. In contrast to the standard laparoscopic Roux-en-Y Gastric Bypass (RYGB), a newer method, the laparoscopic Omega Loop Gastric Bypass (OLGB), has emerged over the past years. It is believed to be the simpler method involving only one anastomosis (instead of two) and therefore potentially reducing morbidity and mortality whilst maintaining comparable excess weight loss. However, since this new type of gastric bypass is similar to the former Billroth II resection (BII), the carcinoma risk is a concern. The OLGB is different from the BII resection in many ways. For instance, it involves creating an approximately 10 cm long narrow gastric pouch which could prevent the suspected underlying pathogenetic mechanism: biliary reflux to the gastric tube and subsequently to the esophagus. Biliary reflux is suspected to stimulate squamous esophageal cells and Barrett's epithelial cells to produce inflammatory mediators and therefore cause oxidative stress, DNA damage and apoptosis which might lead to adenocarcinoma.
Worldwide, there are currently two different ways to perform an OLGB: with or without anti-reflux sutures, which involve sewing the biliopancreatic limb to the staple line of the pouch using V-Loc (non-absorbable) moving upwards as far as easily possible without creating any tension.
This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does it increase after the procedure? Second, does performing an OLGB with or without anti-reflux sutures make a difference in (biliary) reflux exposures of the distal esophagus?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-reflux sutures | Active comparator | Procedure: Omega Loop Gastric Bypass, Device: Bilitec 2000™, Device: V-LocOmega Loop Gastric Bypass with anti-reflux sutures using V-Loc sewing device. Biliary reflux measured using Bilitec 2000™. |
| No anti-reflux sutures | Active comparator | Procedure: Omega Loop Gastric Bypass, Device: Bilitec 2000™Omega Loop Gastric Bypass without anti-reflux sutures. Biliary reflux measured using Bilitec 2000™. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 20 and 70 years
- Body Mass Index ≥ 35.0 kg/m2
- Exclusion of psychological, endocrinological and anesthesiological contraindications
- Willingness to be assigned to either of the two groups
- Follow-up anticipation
Key exclusion criteria (14 listed)
- recent or ongoing cardiovascular event within the last 6 months (myocardial infarction, acute coronary syndrome, angioplasty or coronary bypass operation, insult),
- pulmonary embolism or thrombophlebitis within the last 6 months, other bariatric procedures, e.g. gastric banding, Sleeve Gastrectomy, etc., cancer of various origins (exceptions: basal cell carcinoma or carcinoma in situ, disease-free over the last 5 years),
- significant anemia or coagulopathy,
- serum creatinin ≥ 1.5 mg/dl.,
- serum bilirubin or phosphatase elevated or ALT above 3 times the upper limit, stomach, biliopancreatic operations, splenectomy or colon resections, gastric or duodenal ulcer within the last 6 months,
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 |
|---|---|---|
| Omega Loop Gastric BypassAlso: Mini Gastric Bypass, Single Anastomosis Gastric BypassBariatric/metabolic surgical procedure | Procedure or surgery | Anti-reflux sutures, No anti-reflux sutures |
| Bilitec 2000™The Bilitec 2000™ device will be used to measure the intensity of biliary reflux in the pouch. | Device | Anti-reflux sutures, No anti-reflux sutures |
| V-LocSewing device to perform the anti-reflux sutures. | Device | Anti-reflux sutures |
Primary outcome
Bile Reflux
Time frame: 1 year
The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Biliary exposure will therefore be assessed before and 12 months after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™.
Bile Reflux
Time frame: 1 year
The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Extensive biopsies of the gastric pouch and gastroesophageal junction will be taken to prove histological changes due to biliary reflux.
9 secondary outcomes
Inflammation
Time frame: 1 year
Weight loss
Time frame: 1 year
BMI loss
Time frame: 1 year
Complications by point in time/stage
Time frame: 1 year
Complications by severity
Time frame: 1 year
Resolution of hyperlipidemia
Time frame: 1 year
Resolution of hypertension
Time frame: 1 year
Resolution of diabetes
Time frame: 1 year
Resolution of sleep apnea
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No. Analysis will be performed on anonymized data only. A list cross-linking the patient number to the name will be kept secure and is only available to the principal researcher. Written informed consent will be kept for 15 years.
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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.
Gerhard Prager, Univ. Prof. study director
Vienna Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega Loop Gastric Bypass, Bilitec 2000™ and V-Loc in people with Bile Reflux, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 2 Sep 2020. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel M Felsenreich, Dr. (+43 1 40400 ext. 56220, moritz.felsenreich@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bile Reflux (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2020.