Clinical trial NCT06970093: Comparison of One Anastomisis Gastric Bypass and Duodeno-Jejunostomy for Treating SMA Syndrome
Official title: One Anastomosis Gastric Bypass (OAGB) vs Duodeno-jejunostomy For Treatment of Superior Mesenteric Artery Syndrome: A Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Minimally invasive surgery
Quality of Life
Randomized Controlled Trial
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Improvement in Postprandial Symptoms Score
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Cairo Governorate
Study officials:
affiliation: Faculty of Medicine, Ain Shams University
name: Mohey R Elbanna, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Merrett 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.
citation: Zaraket 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.
citation: Lee 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.
citation: Welsch 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.