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

NCT04686981 | Completed

• 1 other identifier: 20283-0-01
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesenteric Artery Ischemia; Thromboembolism

Keywords

Acute mesenteric artery thrombosis; Hybrid operation; Mechanical thrombectomy

Outcome Measures

Primary Outcomes (1)

• survival rate with preserved bowel function

  Counting data

  within 30 days after operations

Secondary Outcomes (2)

• the incidence of all-cause mortality

  within 30 days after operations

• vascular patency rate

  180 days after operations

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the patients suffering from superior mesenteric artery thromboembolism

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hosipital

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• sifan yang

  Beijing Tsinghua Chang Gung Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department director

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 29, 2020
• Study Start: October 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

CN (1)