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| ID | Type | Description | Link |
|---|---|---|---|
| 20204Y0167 | Other Grant/Funding Number | Shanghai Municipal Health Commission |
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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.
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.
Study endpoints 1) The primary endpoint: postoperative rebleeding rate. 2) Secondary endpoints: hemoglobin, hematocrit, blood transfusion volume, complication rate, mortality, surgical intervention rate.
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
4) Exit/Abort:
4. Interventional treatment process
(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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylic Embolization | Experimental | Prophylactic arterial embolization is performed for the artery in the diseased blood supply area. The embolization material: gelatin sponge particles are recommended, and micro-steel ring can be used as an auxiliary if necessary; after operation, symptomatic and supportive treatment such as acid suppression, hemostasis, blood transfusion, and fluid replacement are given according to the condition. |
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| Sham Embolization | Sham Comparator | After the angiography was completed, no embolization was performed, 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| embolization | Procedure | Prophylactic arterial embolization is performed for the artery in the diseased blood supply area. The embolization material: gelatin sponge particles are recommended, and micro-steel ring can be used as an auxiliary if necessary; after operation, symptomatic and supportive treatment such as acid suppression, hemostasis, blood transfusion, and fluid replacement are given according to the condition. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative rebleeding rate | No more active bleeding within 1 month after surgery, or the bleeding volume is significantly reduced, and no blood transfusion is required | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Hemoglobin count | 1 month |
| blood transfusion volume | how much blood the patients need | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shilong Han, Doctor | Contact | 18917683645 | hanshilong86@163.com | |
| Long Pan, Doctor | Contact | 18917685712 | 18917685712@189.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai 10th People's Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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| complication rate | if there are any complications | 1 month |
| mortality | number of patients dead within one month | 1 month |
| surgical intervention rate. | patients need surgery | 1 month |