Ultrasound Clinical Trial
Official title:
Study on the Relationship Between Variations in the Branching Pattern of the Main Arteries and Patency of Arteriovenous Fistulae in the Upper Limb
NCT number | NCT04613115 |
Other study ID # | TRECKY2020-101 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | June 30, 2022 |
Verified date | October 2020 |
Source | Beijing Tongren Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
In 2019, KDOQI considered that uremic patients with a life expectancy of more than one year should require hemodialysis as an effective renal replacement therapy before preparation of kidney transplantation. Arteriovenous fistula, as the lifeline of uremic patients, plays an important role in their daily hemodialysis. The patency of arteriovenous fistula is largely restricted by the inflow artery. According to available medical literatures, an incidence rate of variations in the branching pattern of the main arteries in the upper limb is ranged from 7.2% to 25.0%. and there is a large difference in the incidence rate between sex and race, furthermore, the incidence rate of variations in the branching pattern of the main arteries in the upper limb of Chinese is still unclear. The brachial artery is the main artery of the upper limb. It gives off two terminal branches at the distal end of the elbow crease, the radial and ulnar arteries, the former one often serves as an arterial inflow to create an arteriovenous fistula in the forearm. High bifurcation of the brachial artery (HBBA) seems to be a common variation which may result in immaturity or disfunction of arteriovenous fistulas. Therefore, the purpose of this study is to investigate the variations in the branching pattern of the main arteries in the upper limb of Chinese, in order to study on the hemodynamic changes, and their influence on the establishment, maturation and failure of arteriovenous fistulas in the upper limb.
Status | Completed |
Enrollment | 1000 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: - patients of vascular surgical Inpatient department - patients will sign the "Informed Consent" and be able to receive related ultrasound examinations Exclusion Criteria: - Patients of other surgical Inpatient department |
Country | Name | City | State |
---|---|---|---|
China | Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University | BeiJing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tongren Hospital |
China,
Aragao JA, da Silva AC, Anunciacao CB, Reis FP. Median artery of the forearm in human fetuses in northeastern Brazil: anatomical study and review of the literature. Anat Sci Int. 2017 Jan;92(1):107-111. doi: 10.1007/s12565-015-0322-x. Epub 2016 Jan 8. — View Citation
Beathard GA, Lok CE, Glickman MH, Al-Jaishi AA, Bednarski D, Cull DL, Lawson JH, Lee TC, Niyyar VD, Syracuse D, Trerotola SO, Roy-Chaudhury P, Shenoy S, Underwood M, Wasse H, Woo K, Yuo TH, Huber TS. Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access. Clin J Am Soc Nephrol. 2018 Mar 7;13(3):501-512. doi: 10.2215/CJN.11531116. Epub 2017 Jul 20. — View Citation
Cikla U, Mukherjee D, Tumturk A, Baskaya MK. Overcoming End-to-End Vessel Mismatch During Superficial Temporal Artery-Radial Artery-M2 Interposition Grafting for Cerebral Ischemia: Tapering Technique. World Neurosurg. 2018 Feb;110:85. doi: 10.1016/j.wneu.2017.10.162. Epub 2017 Nov 6. — View Citation
Hamahata A, Nakazawa H, Takeuchi M, Sakurai H. Usefulness of radial recurrent artery in transplant of radial forearm flap: an anatomical and clinical study. J Reconstr Microsurg. 2012 Mar;28(3):195-8. doi: 10.1055/s-0031-1301071. Epub 2012 Jan 24. — View Citation
Jennings WC, Mallios A, Mushtaq N. Proximal radial artery arteriovenous fistula for hemodialysis vascular access. J Vasc Surg. 2018 Jan;67(1):244-253. doi: 10.1016/j.jvs.2017.06.114. Epub 2017 Sep 11. — View Citation
Kachlik D, Hajek P, Konarik M, Krchov M, Baca V. Coincidence of superficial brachiomedian artery and bitendinous palmaris longus: a case report. Surg Radiol Anat. 2016 Jan;38(1):147-51. doi: 10.1007/s00276-015-1512-x. Epub 2015 Jul 2. — View Citation
KEEN JA. A study of the arterial variations in the limbs, with special reference to symmetry of vascular patterns. Am J Anat. 1961 May;108:245-61. doi: 10.1002/aja.1001080303. No abstract available. — View Citation
Kirksey L. Unrecognized high brachial artery bifurcation is associated with higher rate of dialysis access failure. Semin Dial. 2011 Nov-Dec;24(6):698-702. doi: 10.1111/j.1525-139X.2011.00923.x. Epub 2011 Sep 4. — View Citation
Lee H, Moon YS, Park HS, Kim HT, Choi IJ. A radial artery originating from the thoracoacromial artery. Surg Radiol Anat. 2016 Jul;38(5):631-3. doi: 10.1007/s00276-015-1576-7. Epub 2015 Oct 22. — View Citation
Lioupis C, Mistry H, Junghans C, Haughey N, Freedman B, Tyrrell M, Valenti D. High brachial artery bifurcation is associated with failure of brachio-cephalic autologous arteriovenous fistulae. J Vasc Access. 2010 Apr-Jun;11(2):132-7. doi: 10.1177/112972981001100209. — View Citation
Nasr AY. The radial artery and its variations: anatomical study and clinical implications. Folia Morphol (Warsz). 2012 Nov;71(4):252-62. — View Citation
Pham XD, Kim JJ, Parrish AB, Tom C, Ihenachor EJ, Mina D, de Virgilio C. Racial and Gender Differences in Arterial Anatomy of the Arm. Am Surg. 2016 Oct;82(10):973-976. — View Citation
Rodriguez-Niedenfuhr M, Vazquez T, Nearn L, Ferreira B, Parkin I, Sanudo JR. Variations of the arterial pattern in the upper limb revisited: a morphological and statistical study, with a review of the literature. J Anat. 2001 Nov;199(Pt 5):547-66. doi: 10.1046/j.1469-7580.2001.19950547.x. — View Citation
Shetty SD, Nayak B S, Madhav N V, Sirasanagandla SR, P A. The abnormal origin, course and the distribution of the arteries of the upper limb: a case report. J Clin Diagn Res. 2012 Oct;6(8):1414-6. doi: 10.7860/JCDR/2012/4183.2373. — View Citation
Singer G, Marterer R, Till H, Schmidt B. A rare anatomic variation of the superficial palmar branch of the radial artery causing pain. Surg Radiol Anat. 2018 Mar;40(3):349-352. doi: 10.1007/s00276-017-1936-6. Epub 2017 Nov 9. — View Citation
Tsoucalas G, Eleftheriou A, Panagouli E. High Bifurcation of the Brachial Artery: An Embryological Overview. Cureus. 2020 Feb 25;12(2):e7097. doi: 10.7759/cureus.7097. — View Citation
Vazquez T, Sanudo JR, Carretero J, Parkin I, Rodriguez-Niedenfuhr M. Variations of the radial recurrent artery of clinical interest. Surg Radiol Anat. 2013 Oct;35(8):689-94. doi: 10.1007/s00276-013-1094-4. Epub 2013 Feb 26. — View Citation
Wysiadecki G, Polguj M, Haladaj R, Topol M. Low origin of the radial artery: a case study including a review of literature and proposal of an embryological explanation. Anat Sci Int. 2017 Mar;92(2):293-298. doi: 10.1007/s12565-016-0371-9. Epub 2016 Sep 15. — View Citation
Yang HJ, Gil YC, Jung WS, Lee HY. Variations of the superficial brachial artery in Korean cadavers. J Korean Med Sci. 2008 Oct;23(5):884-7. doi: 10.3346/jkms.2008.23.5.884. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the variations in the branching pattern of the main arteries in the upper limb of Chinese. | brachio-radial artery?superficial brachio-radial artery?brachio-ulnar artery?superficial brachio-ulnar artery?brachioulnoradial artery?brachiointerosseous artery. | baseline | |
Primary | Patency of arteriovenous fistulae in the upper limb | functional patency?primary patency?primary assisted patency?secondary patency | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04546867 -
Establishing a Sonographic Based Algorithm to Verify Pancreatic Stent Position Placed to Prevent Post-ERCP Pancreatitis Before Endoscopic Removal
|
N/A | |
Not yet recruiting |
NCT06053892 -
AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction
|
N/A | |
Completed |
NCT05013476 -
Tele-Ultrasound: VIrtual Hands-on Education for Novice Users
|
N/A | |
Completed |
NCT04554472 -
Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation
|
||
Not yet recruiting |
NCT06456957 -
Fetal Abdominal Subcutaneous Tissue Thickness in Prediction of Fetal Weight in Term Pregnant Women
|
||
Not yet recruiting |
NCT04550793 -
Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
|
||
Completed |
NCT03563196 -
Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
|
||
Completed |
NCT01666626 -
Ultrasound Stiffness Imaging in Crohn's Disease
|
N/A | |
Active, not recruiting |
NCT04928560 -
Diagnosis of Superficial Lymphadenopathy
|
||
Recruiting |
NCT05938790 -
Point of Care Ultrasound in Obstetric Triage
|
N/A | |
Completed |
NCT06098105 -
Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics
|
N/A | |
Recruiting |
NCT02834585 -
Magnetic Resonance Imaging or Ultrasound in Soft Tissue Tumors (MUSTT)
|
N/A | |
Completed |
NCT02661607 -
Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement
|
N/A | |
Completed |
NCT01519167 -
Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
|
Phase 4 | |
Completed |
NCT04612816 -
Live Stream of Ultrasound in Prehospital Medical Care
|
||
Active, not recruiting |
NCT06195488 -
Gastric Ultrasound in Diabetic Patients
|
||
Recruiting |
NCT06199856 -
Assessment System for Sarcopenia Based on Ultrasonographic Data
|
||
Not yet recruiting |
NCT04563897 -
Prospective Multicenter Study on Clinical Application of Sonazoid in Liver Tumor
|
||
Completed |
NCT04574258 -
Prospective Multicenter Study on Clinical Application of Sonozoid in Thyroid Tumor
|
||
Completed |
NCT04124770 -
Neck Position and Ultrasound Landmark of Cricothyroid Membrane
|