Endovascular thromBectomy of Acute Mesentery Vessels Occlusion Hybrid With Emergent Laparoscopic Surgery

Completed

• Conditions: Mesenteric Artery Ischemia; Thromboembolism

• Registration Number: NCT04686981
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief Summary

Acute mesenteric artery thromboembolism(AMT) is one of the important causes of acute abdomen and intestinal necrosis. If the intestinal blood supply is not restore in time, the prognosis of the disease is often poor and even endangers the life of the patient. Through laparoscopic surgery combined with modern minimally invasive endovascular technology, the blood supply of patients' intestine is restored. Observe the perioperative vascular patency rate, all-cause mortality, and the probability of short bowel syndrome. Through the hybrid operating room, we want to seek a multidisciplinary collaborative treatment mode to improve the long-term survival rate of such patients with enough intestines and completely free from TPN, and improve the prognosis of these patients.

Detailed Description

This study is a clinical cohort study; consecutively registered 30 patients with acute intestinal ischemia caused by superior mesenteric artery thromboembolism.

If all the radiography, physical signs, and laboratory markers hint at intestinal necrosis, exploratory laparotomy followed by enterectomy and thrombectomy is the first choice. If none of them hint at intestinal necrosis, endovascular therapy is superior. Laparoscopic exploration followed by endovascular therapy was performed for other patients, after that the intestinal blood supply was evaluated again by laparoscopy.

The main endpoints are the survival rate of bowel function preserved at 30 days, and the secondary endpoints are 30-day mortality, in-hospital mortality, symptoms-free survival rate, and rate of transition to laparotomy.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-29
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients with intestinal ischemia and acute abdomen pain caused by superior mesenteric artery thromboembolism

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Exclusion Criteria

• Those who have acute large-area myocardial infarction, large-area cerebral infarction, or have serious heart failure or sequelae of cerebral infarction within 1 month;
• Combined with portal hypertension, gastrointestinal hemorrhage, portal and mesenteric venous reflux obstruction diseases;
• Contrast agent allergy, severe renal insufficiency, and inability to perform intravascular surgery;
• Past medical history contains superior mesenteric artery thromboembolism.
• Patients diagnosed with intestinal necrosis and peritonitis before surgery based on physical signs and imaging studies who directly undergo laparotomy and incision for thrombectomy.
• Patients without intestinal necrosis or peritonitis based on physical signs and imaging studies, who are treated by endovascular intervention therapy directly.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
survival rate with preserved bowel function	within 30 days after operations	Counting data

Secondary Outcome Measures

Name	Time	Method
the incidence of all-cause mortality	within 30 days after operations	Counting data
vascular patency rate	180 days after operations	Counting data

Trial Locations

Locations (1)

Beijing Tsinghua Chang Gung Hosipital; 🇨🇳 Beijing, Beijing, China