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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05727956
Other study ID # CMUH110-REC1-182
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 9, 2019
Est. completion date February 3, 2023

Study information

Verified date February 2023
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective review was performed for consecutive patients (from 2019 to 2021) who underwent salvage surgeries following failed endovascular therapies for splanchnic artery aneurysms in a tertiary referral center. Salvage operations include total aneurysmectomy with vascular reconstruction and partial aneurysmectomy with directly closing bleeders from the intraluminal space of the aneurysms.


Description:

Salvage surgery for splanchnic artery aneurysm after failed endovascular trials includes one of the following three strategies: (1) aneurysmectomy along with the involved organ if the aneurysm is located within the parenchyma of solid organs (2) aneurysmectomy with vascular reconstruction if the aneurysm outside the solid organ (3)partial aneurysmectomy with direct closing the feeding vessel orifice if the aneurysm occurs in the hostile abdomen.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date February 3, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients underwent salvage surgeries following failed endovascular therapies for splanchnic artery aneurysms - The aneurysms were diagnosed based on medical history and computed tomography (CT) Exclusion Criteria: - Patients only underwent endovascular therapies for artery aneurysms - The aneurysms are not located at the splanchnic artery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Aneurysmectomy
Complete aneurysmectomy with end-to-end anastomosis for the true aneurysm or partial aneurysmectomy with a direct repair.

Locations

Country Name City State
Taiwan China Medical University Hospital, Department of Surgery Taichung

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (38)

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Alsafi A, Bicknell CD, Rudarakanchana N, Kashef E, Gibbs RG, Cheshire NJ, Jenkins MP, Hamady M. Endovascular treatment of thoracic aortic aneurysms with a short proximal landing zone using scalloped endografts. J Vasc Surg. 2014 Dec;60(6):1499-506. doi: 1 — View Citation

Androulakakis Z, Paspatis G, Hatzidakis A, Kokkinaki M, Papanicolaou N, Grammatikakis I, Liapi D, Kandylakis S. Gastric outlet obstruction caused by a giant gastroduodenal artery aneurysm: a case report. Eur J Gastroenterol Hepatol. 2001 Jan;13(1):59-61. — View Citation

ATLS Subcommittee; American College of Surgeons' Committee on Trauma; International ATLS working group. Advanced trauma life support (ATLS(R)): the ninth edition. J Trauma Acute Care Surg. 2013 May;74(5):1363-6. doi: 10.1097/TA.0b013e31828b82f5. No abstract available. — View Citation

Barrionuevo P, Malas MB, Nejim B, Haddad A, Morrow A, Ponce O, Hasan B, Seisa M, Chaer R, Murad MH. A systematic review and meta-analysis of the management of visceral artery aneurysms. J Vasc Surg. 2020 Jul;72(1S):40S-45S. doi: 10.1016/j.jvs.2020.05.018. — View Citation

Biondetti P, Fumarola EM, Ierardi AM, Carrafiello G. Bleeding complications after pancreatic surgery: interventional radiology management. Gland Surg. 2019 Apr;8(2):150-163. doi: 10.21037/gs.2019.01.06. — View Citation

Blomley MJ, Jackson JE. Case report: a gastroduodenal artery pseudoaneurysm presenting with obstructive jaundice and treated by arterial embolization. Clin Radiol. 1994 Oct;49(10):715-8. doi: 10.1016/s0009-9260(05)82668-6. — View Citation

Bougle A, Harrois A, Duranteau J. Resuscitative strategies in traumatic hemorrhagic shock. Ann Intensive Care. 2013 Jan 12;3(1):1. doi: 10.1186/2110-5820-3-1. — View Citation

Chaer RA, Abularrage CJ, Coleman DM, Eslami MH, Kashyap VS, Rockman C, Murad MH. The Society for Vascular Surgery clinical practice guidelines on the management of visceral aneurysms. J Vasc Surg. 2020 Jul;72(1S):3S-39S. doi: 10.1016/j.jvs.2020.01.039. Ep — View Citation

Chapman BM, Bolton JS, Gioe SM, Conway WC. Gastroduodenal Artery Pseudoaneurysm Causing Obstructive Jaundice. Ochsner J. 2021 Spring;21(1):104-107. doi: 10.31486/toj.19.0110. — View Citation

Coccolini F, Montori G, Catena F, Kluger Y, Biffl W, Moore EE, Reva V, Bing C, Bala M, Fugazzola P, Bahouth H, Marzi I, Velmahos G, Ivatury R, Soreide K, Horer T, Ten Broek R, Pereira BM, Fraga GP, Inaba K, Kashuk J, Parry N, Masiakos PT, Mylonas KS, Kirk — View Citation

Donmez H, Men S, Dilli A, Soylu SO, Hekimoglu B. Giant gastroduodenal artery pseudoaneurysm due to polyarteritis nodosa as a cause of obstructive jaundice: imaging findings and coil embolization results. Cardiovasc Intervent Radiol. 2005 Nov-Dec;28(6):850 — View Citation

Grego FG, Lepidi S, Ragazzi R, Iurilli V, Stramana R, Deriu GP. Visceral artery aneurysms: a single center experience. Cardiovasc Surg. 2003 Feb;11(1):19-25. doi: 10.1016/s0967-2109(02)00121-7. — View Citation

Hamid HKS, Suliman AEA, Spiliopoulos S, Zabicki B, Tetreau R, Piffaretti G, Tozzi M. Giant Splenic Artery Pseudoaneurysms: Two Case Reports and Cumulative Review of the Literature. Ann Vasc Surg. 2020 Apr;64:382-388. doi: 10.1016/j.avsg.2019.10.061. Epub — View Citation

Haseen MA, Faizan M, Beg MH, Asif N, Khalid S. Femoral artery pseudoaneurysm following trivial trauma: a rare case scenario. Indian Journal of Thoracic and Cardiovascular Surgery. 2015;31(1):34-7

Hemp JH, Sabri SS. Endovascular management of visceral arterial aneurysms. Tech Vasc Interv Radiol. 2015 Mar;18(1):14-23. doi: 10.1053/j.tvir.2014.12.003. Epub 2014 Dec 29. — View Citation

Jesinger RA, Thoreson AA, Lamba R. Abdominal and pelvic aneurysms and pseudoaneurysms: imaging review with clinical, radiologic, and treatment correlation. Radiographics. 2013 May;33(3):E71-96. doi: 10.1148/rg.333115036. — View Citation

Kossak J, Janik J, Debski J, Rytlewski R, Salacinski A. Pseudoaneurysm of the gastroduodenal artery as a cause of obstructive jaundice. Med Sci Monit. 2001 Jul-Aug;7(4):759-61. — View Citation

Krupski WC, Selzman CH, Floridia R, Strecker PK, Nehler MR, Whitehill TA. Contemporary management of isolated iliac aneurysms. J Vasc Surg. 1998 Jul;28(1):1-11; discussion 11-3. doi: 10.1016/s0741-5214(98)70194-6. — View Citation

Leyon JJ, Littlehales T, Rangarajan B, Hoey ET, Ganeshan A. Endovascular embolization: review of currently available embolization agents. Curr Probl Diagn Radiol. 2014 Jan-Feb;43(1):35-53. doi: 10.1067/j.cpradiol.2013.10.003. — View Citation

Lopera JE. Embolization in trauma: principles and techniques. Semin Intervent Radiol. 2010 Mar;27(1):14-28. doi: 10.1055/s-0030-1247885. — View Citation

Madhusudhan KS, Venkatesh HA, Gamanagatti S, Garg P, Srivastava DN. Interventional Radiology in the Management of Visceral Artery Pseudoaneurysms: A Review of Techniques and Embolic Materials. Korean J Radiol. 2016 May-Jun;17(3):351-63. doi: 10.3348/kjr.2 — View Citation

Marone EM, Mascia D, Kahlberg A, Brioschi C, Tshomba Y, Chiesa R. Is open repair still the gold standard in visceral artery aneurysm management? Ann Vasc Surg. 2011 Oct;25(7):936-46. doi: 10.1016/j.avsg.2011.03.006. Epub 2011 May 28. — View Citation

Moini M, Rasouli MR, Rayatzadeh H, Sheikholeslami G. Management of femoral artery pseudo-aneurysms in Iran: a single centre report of 50 cases. Acta Chir Belg. 2008 Mar-Apr;108(2):226-30. doi: 10.1080/00015458.2008.11680208. — View Citation

Pang TC, Maher R, Gananadha S, Hugh TJ, Samra JS. Peripancreatic pseudoaneurysms: a management-based classification system. Surg Endosc. 2014 Jul;28(7):2027-38. doi: 10.1007/s00464-014-3434-9. Epub 2014 Feb 12. — View Citation

Pasha SF, Gloviczki P, Stanson AW, Kamath PS. Splanchnic artery aneurysms. Mayo Clin Proc. 2007 Apr;82(4):472-9. doi: 10.4065/82.4.472. — View Citation

Pulli R, Dorigo W, Troisi N, Pratesi G, Innocenti AA, Pratesi C. Surgical treatment of visceral artery aneurysms: A 25-year experience. J Vasc Surg. 2008 Aug;48(2):334-42. doi: 10.1016/j.jvs.2008.03.043. — View Citation

Sachdev U, Baril DT, Ellozy SH, Lookstein RA, Silverberg D, Jacobs TS, Carroccio A, Teodorescu VJ, Marin ML. Management of aneurysms involving branches of the celiac and superior mesenteric arteries: a comparison of surgical and endovascular therapy. J Va — View Citation

Saftoiu A, Iordache S, Ciurea T, Dumitrescu D, Popescu M, Stoica Z. Pancreatic pseudoaneurysm of the superior mesenteric artery complicated with obstructive jaundice. A case report. JOP. 2005 Jan 13;6(1):29-35. — View Citation

Saltzberg SS, Maldonado TS, Lamparello PJ, Cayne NS, Nalbandian MM, Rosen RJ, Jacobowitz GR, Adelman MA, Gagne PJ, Riles TS, Rockman CB. Is endovascular therapy the preferred treatment for all visceral artery aneurysms? Ann Vasc Surg. 2005 Jul;19(4):507-1 — View Citation

Shukla AJ, Eid R, Fish L, Avgerinos E, Marone L, Makaroun M, Chaer RA. Contemporary outcomes of intact and ruptured visceral artery aneurysms. J Vasc Surg. 2015 Jun;61(6):1442-7. doi: 10.1016/j.jvs.2015.01.005. Epub 2015 Mar 7. — View Citation

Spiliopoulos S, Sabharwal T, Karnabatidis D, Brountzos E, Katsanos K, Krokidis M, Gkoutzios P, Siablis D, Adam A. Endovascular treatment of visceral aneurysms and pseudoaneurysms: long-term outcomes from a multicenter European study. Cardiovasc Intervent — View Citation

ten Broek RP, Issa Y, van Santbrink EJ, Bouvy ND, Kruitwagen RF, Jeekel J, Bakkum EA, Rovers MM, van Goor H. Burden of adhesions in abdominal and pelvic surgery: systematic review and met-analysis. BMJ. 2013 Oct 3;347:f5588. doi: 10.1136/bmj.f5588. — View Citation

Tetreau R, Beji H, Henry L, Valette PJ, Pilleul F. Arterial splanchnic aneurysms: Presentation, treatment and outcome in 112 patients. Diagn Interv Imaging. 2016 Jan;97(1):81-90. doi: 10.1016/j.diii.2015.06.014. Epub 2015 Aug 17. — View Citation

Tipaldi MA, Krokidis M, Orgera G, Pignatelli M, Ronconi E, Laurino F, Laghi A, Rossi M. Endovascular management of giant visceral artery aneurysms. Sci Rep. 2021 Jan 12;11(1):700. doi: 10.1038/s41598-020-80150-2. — View Citation

Tulsyan N, Kashyap VS, Greenberg RK, Sarac TP, Clair DG, Pierce G, Ouriel K. The endovascular management of visceral artery aneurysms and pseudoaneurysms. J Vasc Surg. 2007 Feb;45(2):276-83; discussion 283. doi: 10.1016/j.jvs.2006.10.049. — View Citation

Zabicki B, Limphaibool N, Holstad MJV, Juszkat R. Endovascular management of pancreatitis-related pseudoaneurysms: A review of techniques. PLoS One. 2018 Jan 29;13(1):e0191998. doi: 10.1371/journal.pone.0191998. eCollection 2018. — View Citation

Zyromski NJ, Vieira C, Stecker M, Nakeeb A, Pitt HA, Lillemoe KD, Howard TJ. Improved outcomes in postoperative and pancreatitis-related visceral pseudoaneurysms. J Gastrointest Surg. 2007 Jan;11(1):50-5. doi: 10.1007/s11605-006-0038-2. — View Citation

* Note: There are 38 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Survival outcomes after surgical intervention Survival outcomes (i.e., overall survival and symptoms-free survival in months) after salvage surgery for the splanchnic aneurysms were collected based on chart reviewing and telephone calls. From surgical intervention to the latest follow-up date (i.e., 2023-Jan-20)
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