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

NCT ID: NCT06970093

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2025-04-30

Brief Summary

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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

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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

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Superior Mesenteric Artery Syndrome Duodenal Obstruction Weight Loss Gastrointestinal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OAGB Surgery Group

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.

Group Type EXPERIMENTAL

One Anastomosis Gastric Bypass

Intervention Type 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.

Duodenojejunostomy Group

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.

Group Type ACTIVE_COMPARATOR

Duodenojejunostomy

Intervention Type 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.

Interventions

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One Anastomosis 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.

Intervention Type PROCEDURE

Duodenojejunostomy

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.

Intervention Type PROCEDURE

Other Intervention Names

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Mini Gastric Bypass Duodenal Bypass

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohey R Elbanna, MD

Role: STUDY_DIRECTOR

Faculty of Medicine, Ain Shams University

Locations

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Ain Shams University Hospitals

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 32309411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18810558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26120301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23076975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17476104 (View on PubMed)

Other Identifiers

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11/2024

Identifier Type: -

Identifier Source: org_study_id

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