Portal Vein ThrombosisNCT02733770
Chances in Portal System Flow After Two Bariatric Procedures
A study testing Laparoscopic sleeve gastrectomy and Laparoscopic mini gastric bypass in people with Portal Vein Thrombosis, run by Assuta Medical Center at 1 site in Israel.
Trial summary
Obesity if a health endemic problem over the entire world. Bariatric surgery is the best chance for those patients with morbid obesity to loss weight and to maintain the loosed weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Vein Thrombosis
- What is being tested?
- Laparoscopic sleeve gastrectomy and Laparoscopic mini gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2017to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients accepted for bariatric surgery for the bariatric surgery committee.
- Primary procedure
- No hypercoagulability status know
Who cannot join
- Hypercoagulability status
- patients after any abdominal surgery of the forgut
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison in Portal Flow After Sleeve Gastrectomy and Mini Gastric Bypass
Obesity if a health endemic problem over the entire world. Bariatric surgery is the best chance for those patients with morbid obesity to loss weight and to maintain the loosed weight.
Metabolic surgery is the new name for bariatric surgery like sleeve gastrectomy and gastric by pass due to the recognized changes in the homeostasis of the hormonal secretion responsive to the hunger status. After sleeve gastrectomy we observe many patients with thrombus of the portal vein system. This phenomena may be attributed to changes in the portal flow due to devascularization of the great curvature of the stomach.
The aim of the study is to compare the portal flow by intra-operative Doppler ultrasound before and after surgery of the two procedures as sleeve gastrectomy and gastric bypass, were the vascularization is not changed by the surgery.
- Conditions
- Portal Vein Thrombosis
- Being tested
- Laparoscopic sleeve gastrectomy, Laparoscopic mini gastric bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sleeve gastrectomyProcedure or surgery
Doppler ultrasound.
Laparoscopic mini gastric bypassProcedure or surgery
Doppler ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy | Active comparator | US DOopler for Patient with BMI of 40 or more than 35 with co-morbidities underwent Sleeve gastrectomy Receives: Procedure: Laparoscopic sleeve gastrectomy; Procedure: Laparoscopic mini gastric bypass |
| Mini Gastric Bypass | Active comparator | US DOopler for Patient with BMI of 40 or more than 35 wtih co-morbidities underwent mini gastric bypass Receives: Procedure: Laparoscopic sleeve gastrectomy; Procedure: Laparoscopic mini gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Portal flow
physiological parameter
Measured: three month
Secondary outcomes (1)
Determine the relation between the operation and thrombosis
physiological parameter and number of thrombosis found. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start1 Jan 2017
- Primary completion1 Jan 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein ThrombosisStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733770
- Sponsor's protocol ID
- AMC0416
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2016
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison in Portal Flow After Sleeve Gastrectomy and Mini Gastric Bypass
- ClinicalTrials.gov ID
- NCT02733770
- Acronym / sponsor ID
- AMC0416
- Conditions
- Portal Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 12 Apr 2016 (estimated)
- 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.
Obesity if a health endemic problem over the entire world. Bariatric surgery is the best chance for those patients with morbid obesity to loss weight and to maintain the loosed weight.
Metabolic surgery is the new name for bariatric surgery like sleeve gastrectomy and gastric by pass due to the recognized changes in the homeostasis of the hormonal secretion responsive to the hunger status. After sleeve gastrectomy we observe many patients with thrombus of the portal vein system. This phenomena may be attributed to changes in the portal flow due to devascularization of the great curvature of the stomach.
The aim of the study is to compare the portal flow by intra-operative Doppler ultrasound before and after surgery of the two procedures as sleeve gastrectomy and gastric bypass, were the vascularization is not changed by the surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy | Active comparator | Procedure: Laparoscopic sleeve gastrectomy, Procedure: Laparoscopic mini gastric bypassUS DOopler for Patient with BMI of 40 or more than 35 with co-morbidities underwent Sleeve gastrectomy |
| Mini Gastric Bypass | Active comparator | Procedure: Laparoscopic sleeve gastrectomy, Procedure: Laparoscopic mini gastric bypassUS DOopler for Patient with BMI of 40 or more than 35 wtih co-morbidities underwent mini gastric bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients accepted for bariatric surgery for the bariatric surgery committee.
- Primary procedure
- No hypercoagulability status know
Key exclusion criteria (2 listed)
- Hypercoagulability status
- patients after any abdominal surgery of the forgut
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 |
|---|---|---|
| Laparoscopic sleeve gastrectomyDoppler ultrasound. | Procedure or surgery | Mini Gastric Bypass, Sleeve gastrectomy |
| Laparoscopic mini gastric bypassDoppler ultrasound. | Procedure or surgery | Mini Gastric Bypass, Sleeve gastrectomy |
Primary outcome
Measurement of Portal flow
Time frame: three month
physiological parameter
1 secondary outcome
Determine the relation between the operation and thrombosis
Time frame: three month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Portal Vein Thrombosis
RecruitingPhase 2
BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + Surgery/SBRT for BCLC-C HCC With PVTT and/or Oligometastases
Hepatocellular Carcinoma, Portal Vein Tumor Thrombus
Active, not recruitingObservational study
Percutaneous Portal Vein Recanalization for Refractory Portal Hypertension in Children With Non-Cirrhotic Extrahepatic Portal Vein Obstruction
Hypertension, Portal, Interventional Radiology
RecruitingPhase 2
Iparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
HCC - Hepatocellular Carcinoma
Recruiting
IRE After Targeted Immunotherapy in HCC With Portal Vein Tumor Thrombus
IRE
RecruitingPhase 2
Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis
Hepatocellular Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic sleeve gastrectomy and Laparoscopic mini gastric bypass in people with Portal Vein Thrombosis, run by Assuta Medical Center at 1 site in Israel.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 26 Mar 2025. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Measurement of Portal flow (time frame: three month). 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 26 Mar 2025.