Superior Mesenteric Artery SyndromeNCT06970093
Comparison of One Anastomisis Gastric Bypass and Duodeno-Jejunostomy for Treating SMA Syndrome
A study testing One Anastomosis Gastric Bypass and Duodenojejunostomy in people with Superior Mesenteric Artery Syndrome and Duodenal Obstruction, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to find out which surgery works better to treat people with a rare condition called Superior Mesenteric Artery Syndrome (SMAS). This condition causes the duodenum to be squeezed between two arteries, leading to severe nausea, vomiting, and weight loss. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Superior Mesenteric Artery Syndrome, Duodenal Obstruction, Weight Loss
- What is being tested?
- One Anastomosis Gastric Bypass and Duodenojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2024to 30 Apr 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Superior Mesenteric Artery Syndrome (SMAS) based on symptoms and radiologic findings
- No prior gastric or intestinal surgery
- Willingness and ability to participate in follow-up for 12 months
Who cannot join
- Presence of other gastrointestinal pathologies mimicking SMAS
- Severe comorbidities contraindicating surgery (e.g., advanced cardiac or pulmonary disease)
- History of previous bariatric or upper GI surgery
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Anastomosis Gastric Bypass (OAGB) vs Duodeno-jejunostomy For Treatment of Superior Mesenteric Artery Syndrome: A Prospective Randomized Control Trial
The goal of this clinical trial is to find out which surgery works better to treat people with a rare condition called Superior Mesenteric Artery Syndrome (SMAS). This condition causes the duodenum to be squeezed between two arteries, leading to severe nausea, vomiting, and weight loss. The researchers are comparing two types of surgery:
- One Anastomosis Gastric Bypass (OAGB)
- Duodeno-jejunostomy (DJ)
Read more
The main questions this study will answer are:
- Which surgery improves symptoms and nutritional status better?
- Which surgery leads to fewer complications and better quality of life?
Participants will:
- Be randomly assigned to one of the two surgeries
- Be followed for 12 months after the operation
- Complete follow-up visits and nutritional assessments
- Answer questions about their symptoms and overall well-being
Read the detailed description
Superior Mesenteric Artery Syndrome (SMAS) is a rare but serious condition where part of the small intestine (the duodenum) gets compressed between major blood vessels. This can cause severe digestive symptoms and weight loss. Surgery is often needed when other treatments do not work.
This prospective randomized controlled trial compares two surgical options to relieve the compression: One Anastomosis Gastric Bypass (OAGB) and Duodeno-jejunostomy (DJ). Both surgeries aim to improve food passage and relieve symptoms, but they work differently and have different effects on digestion and nutrition.
Participants will be randomly assigned to one of the two surgical procedures. The study will collect data before and after surgery on symptoms, nutritional status, complications, and quality of life. Follow-up will continue for 12 months.
The goal is to help surgeons and patients choose the most effective and safest surgical treatment for SMAS.
- Conditions
- Superior Mesenteric Artery Syndrome, Duodenal Obstruction, Weight Loss, Gastrointestinal Disease
- Being tested
- One Anastomosis Gastric Bypass, Duodenojejunostomy
- Keywords
- Superior Mesenteric Artery Syndrome, SMAS, OAGB, One Anastomisis Gastric Bypass, Duodenojejunostomy, Gastrc Bypass, Intestinal Obstruction, Malnutrition, Minimally invasive surgery, Quality of Life, Randomized Controlled Trial
- Medical subject headings
- Superior Mesenteric Artery Syndrome, Duodenal Obstruction, Weight Loss, Gastrointestinal Diseases, Intestinal Obstruction, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Anastomosis Gastric BypassProcedure or surgery
Also called Mini Gastric Bypass
Participants will undergo One Anastomosis Gastric Bypass (OAGB), a laparoscopic bariatric procedure that creates a long narrow gastric pouch and anastomoses it to a loop of jejunum approximately 150-200 cm from the ligament of Treitz. This bypasses the compressed duodenum to relieve symptoms of SMAS while promoting weight gain or nutritional restoration in undernourished patients.
DuodenojejunostomyProcedure or surgery
Also called Duodenal Bypass
Participants will undergo Duodenojejunostomy (DJ), a standard surgical procedure to bypass the compressed segment of the duodenum. It involves creating an anastomosis between the duodenum and the jejunum distal to the point of compression, allowing normal food passage and relieving symptoms of Superior Mesenteric Artery Syndrome.
| Study group | Role | What they receive |
|---|---|---|
| OAGB Surgery Group | Experimental | Participants in this arm will undergo One Anastomosis Gastric Bypass (OAGB). The procedure involves creating a long gastric pouch and connecting it to a loop of the jejunum. This reroutes food to bypass the compressed duodenum, aiming to relieve symptoms of Superior Mesenteric Artery Syndrome (SMAS) while preserving nutritional status. Receives: Procedure: One Anastomosis Gastric Bypass |
| Duodenojejunostomy Group | Active comparator | Participants in this arm will undergo Duodenojejunostomy (DJ), a surgical procedure in which a bypass connection is made between the duodenum and the jejunum. This relieves the duodenal compression caused by SMAS and restores normal food passage. Receives: Procedure: Duodenojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Postprandial Symptoms Scores
Change in severity of postprandial symptoms (e.g., nausea, vomiting, early satiety, abdominal pain), assessed using standardized scoring tools: the Numeric Rating Scale (NRS) and the Visual Analog Scale (VAS).
Both scales range from 0 to 10, where 0 indicates no symptoms and 10 indicates the most severe symptoms imaginable. Higher scores reflect worse symptom severity. The Functional Living Index-Emesis (FLIE) score used to assess nausea and vomiting improvement.
Measured: 12 months
Secondary outcomes (1)
Change in Body Mass Index (BMI)
Change in BMI from baseline to 12 months postoperatively, used to assess nutritional recovery and weight regain after surgery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start5 Mar 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Superior Mesenteric Artery SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to undergo either One Anastomosis Gastric Bypass (OAGB) or Duodenojejunostomy (DJ). Each participant receives one type of surgery, and outcomes are assessed after 12 months of follow-up.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohey R Elbanna, MD, Study director, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970093
- Sponsor's protocol ID
- 11/2024
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcome measures will be available to researchers upon reasonable request after the study is published. Data sharing will be considered for academic and clinical research purposes.
Publications
Aleman R, Lo Menzo E, Szomstein S, Rosenthal RJ. Efficiency and risks of one-anastomosis gastric bypass. Ann Transl Med. 2020 Mar;8(Suppl 1):S7. doi: 10.21037/atm.2020.02.03.
PubMed 32309411Merrett ND, Wilson RB, Cosman P, Biankin AV. Superior mesenteric artery syndrome: diagnosis and treatment strategies. J Gastrointest Surg. 2009 Feb;13(2):287-92. doi: 10.1007/s11605-008-0695-4. Epub 2008 Sep 23.
PubMed 18810558Zaraket V, Deeb L. Wilkie's Syndrome or Superior Mesenteric Artery Syndrome: Fact or Fantasy? Case Rep Gastroenterol. 2015 Jun 5;9(2):194-9. doi: 10.1159/000431307. eCollection 2015 May-Aug.
PubMed 26120301Lee TH, Lee JS, Jo Y, Park KS, Cheon JH, Kim YS, Jang JY, Kang YW. Superior mesenteric artery syndrome: where do we stand today? J Gastrointest Surg. 2012 Dec;16(12):2203-11. doi: 10.1007/s11605-012-2049-5. Epub 2012 Oct 18.
PubMed 23076975Welsch T, Buchler MW, Kienle P. Recalling superior mesenteric artery syndrome. Dig Surg. 2007;24(3):149-56. doi: 10.1159/000102097. Epub 2007 Apr 27.
PubMed 17476104
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Anastomosis Gastric Bypass (OAGB) vs Duodeno-jejunostomy For Treatment of Superior Mesenteric Artery Syndrome: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06970093
- Acronym / sponsor ID
- 11/2024
- Conditions
- Superior Mesenteric Artery Syndrome, Duodenal Obstruction, Weight Loss, Gastrointestinal Disease
- Keywords
- Superior Mesenteric Artery Syndrome, SMAS, OAGB, One Anastomisis Gastric Bypass, Duodenojejunostomy, Gastrc Bypass, Intestinal Obstruction, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 14 May 2025 (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 goal of this clinical trial is to find out which surgery works better to treat people with a rare condition called Superior Mesenteric Artery Syndrome (SMAS). This condition causes the duodenum to be squeezed between two arteries, leading to severe nausea, vomiting, and weight loss. The researchers are comparing two types of surgery:
- One Anastomosis Gastric Bypass (OAGB)
- Duodeno-jejunostomy (DJ)
The main questions this study will answer are:
- Which surgery improves symptoms and nutritional status better?
- Which surgery leads to fewer complications and better quality of life?
Participants will:
- Be randomly assigned to one of the two surgeries
- Be followed for 12 months after the operation
- Complete follow-up visits and nutritional assessments
- Answer questions about their symptoms and overall well-being
Detailed description
Superior Mesenteric Artery Syndrome (SMAS) is a rare but serious condition where part of the small intestine (the duodenum) gets compressed between major blood vessels. This can cause severe digestive symptoms and weight loss. Surgery is often needed when other treatments do not work.
This prospective randomized controlled trial compares two surgical options to relieve the compression: One Anastomosis Gastric Bypass (OAGB) and Duodeno-jejunostomy (DJ). Both surgeries aim to improve food passage and relieve symptoms, but they work differently and have different effects on digestion and nutrition.
Participants will be randomly assigned to one of the two surgical procedures. The study will collect data before and after surgery on symptoms, nutritional status, complications, and quality of life. Follow-up will continue for 12 months.
The goal is to help surgeons and patients choose the most effective and safest surgical treatment for SMAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to undergo either One Anastomosis Gastric Bypass (OAGB) or Duodenojejunostomy (DJ). Each participant receives one type of surgery, and outcomes are assessed after 12 months of follow-up.
| Arm | Type | Receives |
|---|---|---|
| OAGB Surgery Group | Experimental | Procedure: One Anastomosis Gastric BypassParticipants in this arm will undergo One Anastomosis Gastric Bypass (OAGB). The procedure involves creating a long gastric pouch and connecting it to a loop of the jejunum. This reroutes food to bypass the compressed duodenum, aiming to relieve symptoms of Superior Mesenteric Artery Syndrome (SMAS) while preserving nutritional status. |
| Duodenojejunostomy Group | Active comparator | Procedure: DuodenojejunostomyParticipants in this arm will undergo Duodenojejunostomy (DJ), a surgical procedure in which a bypass connection is made between the duodenum and the jejunum. This relieves the duodenal compression caused by SMAS and restores normal food passage. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Superior Mesenteric Artery Syndrome (SMAS) based on symptoms and radiologic findings
- No prior gastric or intestinal surgery
- Willingness and ability to participate in follow-up for 12 months
Key exclusion criteria (4 listed)
- Presence of other gastrointestinal pathologies mimicking SMAS
- Severe comorbidities contraindicating surgery (e.g., advanced cardiac or pulmonary disease)
- History of previous bariatric or upper GI surgery
- Refusal or inability to provide informed consent
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 |
|---|---|---|
| One Anastomosis Gastric BypassAlso: Mini Gastric BypassParticipants will undergo One Anastomosis Gastric Bypass (OAGB), a laparoscopic bariatric procedure that creates a long narrow gastric pouch and anastomoses it to a loop of jejunum approximately 150-200 cm from the ligament of Treitz. This bypasses the compressed duodenum to relieve symptoms of SMAS while promoting weight gain or nutritional restoration in undernourished patients. | Procedure or surgery | OAGB Surgery Group |
| DuodenojejunostomyAlso: Duodenal BypassParticipants will undergo Duodenojejunostomy (DJ), a standard surgical procedure to bypass the compressed segment of the duodenum. It involves creating an anastomosis between the duodenum and the jejunum distal to the point of compression, allowing normal food passage and relieving symptoms of Superior Mesenteric Artery Syndrome. | Procedure or surgery | Duodenojejunostomy Group |
Primary outcome
Improvement in Postprandial Symptoms Scores
Time frame: 12 months
Change in severity of postprandial symptoms (e.g., nausea, vomiting, early satiety, abdominal pain), assessed using standardized scoring tools: the Numeric Rating Scale (NRS) and the Visual Analog Scale (VAS). Both scales range from 0 to 10, where 0 indicates no symptoms and 10 indicates the most severe symptoms imaginable. Higher scores reflect worse symptom severity. The Functional Living Index-Emesis (FLIE) score used to assess nausea and vomiting improvement.
1 secondary outcome
Change in Body Mass Index (BMI)
Time frame: 12 months
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 8 Dec 2025.
- Background: PubMed 32309411Aleman R, Lo Menzo E, Szomstein S, Rosenthal RJ. Efficiency and risks of one-anastomosis gastric bypass. Ann Transl Med. 2020 Mar;8(Suppl 1):S7. doi: 10.21037/atm.2020.02.03.
- Background: PubMed 18810558Merrett ND, Wilson RB, Cosman P, Biankin AV. Superior mesenteric artery syndrome: diagnosis and treatment strategies. J Gastrointest Surg. 2009 Feb;13(2):287-92. doi: 10.1007/s11605-008-0695-4. Epub 2008 Sep 23.
- Background: PubMed 26120301Zaraket V, Deeb L. Wilkie's Syndrome or Superior Mesenteric Artery Syndrome: Fact or Fantasy? Case Rep Gastroenterol. 2015 Jun 5;9(2):194-9. doi: 10.1159/000431307. eCollection 2015 May-Aug.
- Background: PubMed 23076975Lee TH, Lee JS, Jo Y, Park KS, Cheon JH, Kim YS, Jang JY, Kang YW. Superior mesenteric artery syndrome: where do we stand today? J Gastrointest Surg. 2012 Dec;16(12):2203-11. doi: 10.1007/s11605-012-2049-5. Epub 2012 Oct 18.
- Background: PubMed 17476104Welsch T, Buchler MW, Kienle P. Recalling superior mesenteric artery syndrome. Dig Surg. 2007;24(3):149-56. doi: 10.1159/000102097. Epub 2007 Apr 27.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to primary and secondary outcome measures will be available to researchers upon reasonable request after the study is published. Data sharing will be considered for academic and clinical research purposes.
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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.
Mohey R Elbanna, MD study director
Faculty of Medicine, Ain Shams 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 One Anastomosis Gastric Bypass and Duodenojejunostomy in people with Superior Mesenteric Artery Syndrome and Duodenal Obstruction, run by Ain Shams University at 1 site in Egypt.
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 4 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 8 Dec 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 Egypt. 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?
Improvement in Postprandial Symptoms Scores (time frame: 12 months). 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 NCT06970093, which also lists 5 linked publications.
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 8 Dec 2025.