Comparison of One Anastomisis Gastric Bypass and Duodeno-Jejunostomy for Treating SMA Syndrome

NCT06970093 | Completed DMC

• 1 other identifier: 11/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Change in Body Mass Index (BMI)

  12 months

Study Arms (2)

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.

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.

Procedure: Duodenojejunostomy

Interventions

One Anastomosis Gastric Bypass PROCEDURE

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.

Also known as: Mini Gastric Bypass

OAGB Surgery Group

Duodenojejunostomy PROCEDURE

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.

Also known as: Duodenal Bypass

Duodenojejunostomy Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11566, Egypt

Location

Related Publications (5)

• 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.

  PMID: 32309411 BACKGROUND

• 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.

  PMID: 18810558 BACKGROUND

• 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.

  PMID: 26120301 BACKGROUND

• 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.

  PMID: 23076975 BACKGROUND

• 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.

  PMID: 17476104 BACKGROUND

MeSH Terms

Conditions

Superior Mesenteric Artery Syndrome; Duodenal Obstruction; Weight Loss; Gastrointestinal Diseases; Intestinal Obstruction; Malnutrition

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Digestive System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Mohey R Elbanna, MD

  Faculty of Medicine, Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: March 5, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting 3 months after publication of the primary results and for up to 3 years after publication
• Access Criteria: De-identified individual participant data (IPD) and supporting documents such as the study protocol and statistical analysis plan will be available to qualified researchers, academic institutions, or healthcare professionals. These individuals must submit a written request with a sound scientific rationale for secondary analysis. Access will be granted at the discretion of the principal investigator. Approved users must sign a data use agreement to ensure confidentiality and appropriate use. All requests should be sent to the principal investigator's official institutional email address.

Locations

EG (1)