Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05550649 |
| Other study ID # |
SHSY-IEC-5.0/22K8/P01 |
| Secondary ID |
20204Y0167 |
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2022 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
September 2022 |
| Source |
Shanghai 10th People's Hospital |
| Contact |
Shilong Han, Doctor |
| Phone |
18917683645 |
| Email |
hanshilong86[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Guided by clinical problems, this study focused on the problems encountered in clinical
practice, with the interventional treatment of emergency gastrointestinal bleeding as the
breakthrough point, and focused on the dilemma of treatment selection for patients with
negative angiography in gastrointestinal bleeding. At present, there is no report on relevant
clinical and basic research on the selection of treatment strategies for patients with
negative ANVUGIB angiography. Whether prophylactic arterial embolization can benefit patients
and whether it can reduce mortality is an urgent clinical problem to be solved.
Description:
1. Research subjects Patients who were admitted to our hospital from January 2021 to
December 2023 and underwent interventional therapy for acute non-variceal upper
gastrointestinal bleeding and were negative on angiography were selected.
Once the subjects signed the informed consent and participated in the screening, the
subjects who met all the following inclusion criteria according to the experimental
protocol and did not meet any of the exclusion criteria were eligible for screening.
2. Study endpoints 1) The primary endpoint: postoperative rebleeding rate. 2) Secondary
endpoints: hemoglobin, hematocrit, blood transfusion volume, complication rate,
mortality, surgical intervention rate.
3. In/Out Criteria 1) Inclusion criteria: (1) Age: 18~75 years old (including 18 years old
and 75 years old); (2) Bleeding of gastric or duodenal ulcers that have failed
endoscopic therapy; (3) Anastomotic bleeding after gastrointestinal anastomosis; (4)
Anastomotic bleeding after cholangioenterostomy; (5) Bleeding after ERCP; (6) There were
no indirect signs of contrast agent spillage and bleeding in angiography.
2) Exclusion criteria:
(1) Age: <18 years old or >75 years old; (2) Rupture and bleeding of gastric fundus
esophageal varices; (3) Active bleeding can be seen on angiography; (4) Upper
gastrointestinal bleeding caused by other causes other than the inclusion criteria; (5)
Unexplained upper gastrointestinal bleeding; (6) Those who have undergone interventional
therapy in the past; (7) Allergy to iodine-containing contrast agents; (8) Uncorrectable
coagulation dysfunction and uncontrolled systemic infection; (9) There is functional failure
of important organs (heart, liver, kidney, etc.); (10) History of gastrointestinal
radiotherapy in the past 1 year; (11) Those who are not expected to complete the follow-up;
(12) Expected survival shorter than 6 months. 3) Elimination criteria
1. After enrollment, it is found that the subjects do not meet the inclusion criteria or
meet the exclusion criteria;
2. Other diseases or conditions occurred during the trial, which, as judged by the
investigator, significantly affected the evaluation of clinical status and research
endpoints;
3. Those whose treatment was interrupted due to various reasons or whose case records were
incomplete, were determined by the investigators to be unevaluable.
4) Exit/Abort:
1. The subject himself or his legal representative requests to withdraw from the research;
2. Lost to follow-up;
3. DEATH. For all cases of rejection, withdrawal/discontinuation, the reason for rejection,
withdrawal/discontinuation must be recorded on the case report form and subject medical
records.
4. Interventional treatment process
1. Preoperative preparation: perfect electrocardiogram, gastroscope (optional), chest
X-ray/chest CT (optional), enhanced abdominal CT (optional), blood routine,
biochemistry, coagulation function, stool routine + occult blood, eight items before
surgery etc.; signed informed consent for interventional therapy.
2. Angiography: (1) Prepare the skin at the puncture site, sterilize and lay down sheets;
(2) Determine the puncture point: routinely choose the right femoral artery, or the left
femoral artery or radial artery, (3) Lidocaine Anesthetize the puncture point, puncture
and introduce the 4-5F arterial sheath; (4) Conventional angiography: celiac artery
(5-7ml/s, total amount of contrast agent 25-35ml, 300 psi), superior mesenteric artery
(5-7ml/s, Total volume of contrast agent 25-35ml, 300 psi). (5) Superselective
angiography: superselective angiography of the blood supply artery in the lesion area is
performed according to the cause of bleeding, the lesion site determined by endoscopic
or enhanced CT, and the flow rate of contrast agent, the duration of angiography and the
pressure are determined according to the diameter of the blood vessel.
3. Group processing:
(1) Control group: After angiography, no embolization was given, the catheter was withdrawn,
the vascular sheath was removed, and symptomatic and supportive treatments such as acid
suppression, hemostasis, blood transfusion, and fluid replacement were given.
(2) Observation group: Prophylactic arterial embolization was performed for the artery in the
blood supply area of the lesion. Embolization material: gelatin sponge particles are
recommended, and micro-steel ring can be used as an auxiliary if necessary; postoperatively,
according to the condition, symptomatic acid suppression, hemostasis, blood transfusion, and
fluid replacement were given. and supportive care.
Indications for blood transfusion: (1) systolic blood pressure < 90 mmHg, or a decrease of >
30 mmHg from baseline systolic blood pressure; (2) hemoglobin < 70 g/L, hematocrit < 25%; (3)
increased heart rate (> 120 times/min).
4. Postoperative treatment: (1) Monitoring vital signs; (2) On the 1st, 7th, and 14th days
after operation, and in January and March respectively, test blood routine, coagulation
function, liver and kidney function, stool routine + occult blood, etc.; ( 3) Observe the
bleeding situation; (4) Observe and record adverse reactions.
6. Angiographic findings
1. Positive signs of bleeding: contrast agent spillage, pseudoaneurysm, irregular arterial
stenosis/truncation.
2. Negative signs of bleeding: the shape of blood vessels is obviously abnormal, and the
above positive signs are not present on angiography.
6. Efficacy evaluation Technical success: Successful embolization of the target arterial
vessel. Technical failure: The target artery was not successfully embolized. Clinical
success: no more active bleeding within 1 month after surgery, or significant reduction in
bleeding volume, no need for blood transfusion therapy Bleeding stopped: (1) bleeding from
gastric tube or abdominal drainage tube stopped; (2) the patient's symptoms improved, heart
rate and blood pressure were stable; (3) urine output > 0.5 ml/kg/h. Active bleeding: (1)
bleeding from gastric tube or abdominal drainage tube; (2) increased frequency of hematemesis
or melena, bright red vomit or dark red blood in stool, or active bowel sounds; (3) rapid
infusion Blood transfusion, the performance of peripheral circulatory failure did not improve
significantly, or although it temporarily improved and then deteriorated, the central venous
pressure still fluctuated, stabilized and then decreased again; (4) red blood cell count,
hemoglobin concentration and hematocrit continued to decline, reticulum The red blood cell
count continued to increase; (5) the blood urea nitrogen continued or increased again when
the fluid and urine volume were sufficient.
7. Safety evaluation:
1. Serious complications: require surgical treatment or prolong hospital stay for ≥2 weeks.
2. Mild complications: no surgical treatment or prolonged hospital stay is required for
less than 2 weeks.
Recording of complications: from the time the subjects signed the informed consent, until the
subjects completed or withdrew from the trial. All adverse events that occurred during the
trial must be recorded on a case report form. The contents of the records should include: the
occurrence time, severity, duration, measures taken and outcomes of adverse events.
Technical difficulties: For the judgment of negative angiography, it is generally accepted
that when the bleeding rate is lower than 15ml/min, the bleeding point cannot be found by DSA
angiography, but it is also related to the pressure of the high-pressure syringe, the
diameter of the blood vessel and the experience of the operator.
