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

Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital

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.

Study Overview

• Status: Completed
• Conditions: Thromboembolism; Mesenteric Artery Ischemia

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 Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102218
      • Beijing Tsinghua Chang Gung Hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

the patients suffering from superior mesenteric artery thromboembolism

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

mesenteric artery thromboembolism patients; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival rate with preserved bowel function	Counting data	within 30 days after operations

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of all-cause mortality	Counting data	within 30 days after operations
vascular patency rate	Counting data	180 days after operations

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Study Director: sifan yang, Beijing Tsinghua Chang Gung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mechanical thrombectomy; Hybrid operation; Acute mesenteric artery thrombosis
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Ischemia; Thromboembolism
• Other Study ID Numbers: 20283-0-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No