Failure in Endovascular TherapyNCT05727956
Salvage Surgeries for Splanchnic Artery Aneurysms After Failed Endovascular Therapies: Cases Series
An observational study of Failure in Endovascular Therapy and Splanchnic Aneurysm, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Failure in Endovascular Therapy, Splanchnic Aneurysm, Mass Effect
- What is being tested?
- Aneurysmectomy
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Aug 2019to 3 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who received surgical salvages after failed endovascular therapies for splanchnic arterial aneurysms in a tertiary university hospital (China Medical University Hospital, Taichung, Taiwan) between 2019 and 2021.
Who may be able to join
- Patients underwent salvage surgeries following failed endovascular therapies for splanchnic artery aneurysms
- The aneurysms were diagnosed based on medical history and computed tomography (CT)
Who cannot join
- Patients only underwent endovascular therapies for artery aneurysms
- The aneurysms are not located at the splanchnic artery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- Aneurysmectomy
- Keywords
- salvage surgery, failed endovascular therapy, giant aneurysm, mass effect, jaundice, surgery
- Medical subject headings
- Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AneurysmectomyProcedure or surgery
Complete aneurysmectomy with end-to-end anastomosis for the true aneurysm or partial aneurysmectomy with a direct repair.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From surgical intervention to the latest follow-up date (i.e., 2023-Jan-20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start9 Aug 2019
- Primary completion20 Jan 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Failure in Endovascular TherapyStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Chieh Yeh, China Medical University Hospital
- Investigators
- Chun-Chieh Yeh, M.D., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727956
- Sponsor's protocol ID
- CMUH110-REC1-182
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23609291Akbulut S, Otan E. Management of Giant Splenic Artery Aneurysm: Comprehensive Literature Review. Medicine (Baltimore). 2015 Jul;94(27):e1016. doi: 10.1097/MD.0000000000001016.
PubMed 26166071Pulli 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.
PubMed 18644480Tipaldi 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.
PubMed 33436829Pasha 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.
PubMed 17418076Shukla 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.
PubMed 25752692Chaer 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. Epub 2020 Mar 20.
PubMed 32201007Tetreau 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.
PubMed 26292616Spiliopoulos 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 Radiol. 2012 Dec;35(6):1315-25. doi: 10.1007/s00270-011-0312-x. Epub 2011 Dec 7.
PubMed 22146976Pang 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.
PubMed 24519028Marone 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.
PubMed 21620671Barrionuevo 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.
PubMed 32553135Androulakakis 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. doi: 10.1097/00042737-200101000-00011.
PubMed 11204812Saftoiu 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.
PubMed 15650282Chapman 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.
PubMed 33828434
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Surgeries for Splanchnic Artery Aneurysms After Failed Endovascular Therapies: Cases Series
- ClinicalTrials.gov ID
- NCT05727956
- Acronym / sponsor ID
- CMUH110-REC1-182
- Keywords
- salvage surgery, failed endovascular therapy, giant aneurysm, mass effect, jaundice, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received surgical salvages after failed endovascular therapies for splanchnic arterial aneurysms in a tertiary university hospital (China Medical University Hospital, Taichung, Taiwan) between 2019 and 2021.
Key inclusion criteria (2 listed)
- Patients underwent salvage surgeries following failed endovascular therapies for splanchnic artery aneurysms
- The aneurysms were diagnosed based on medical history and computed tomography (CT)
Key exclusion criteria (2 listed)
- Patients only underwent endovascular therapies for artery aneurysms
- The aneurysms are not located at the splanchnic artery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AneurysmectomyComplete aneurysmectomy with end-to-end anastomosis for the true aneurysm or partial aneurysmectomy with a direct repair. | Procedure or surgery | – |
Primary outcome
Survival outcomes after surgical intervention
Time frame: From surgical intervention to the latest follow-up date (i.e., 2023-Jan-20)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 23609291ATLS 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.
- Background: PubMed 26166071Akbulut S, Otan E. Management of Giant Splenic Artery Aneurysm: Comprehensive Literature Review. Medicine (Baltimore). 2015 Jul;94(27):e1016. doi: 10.1097/MD.0000000000001016.
- Results publication: PubMed 18644480Pulli 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.
- Results publication: PubMed 33436829Tipaldi 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.
- Results publication: PubMed 17418076Pasha 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.
- Results publication: PubMed 25752692Shukla 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.
- Results publication: PubMed 32201007Chaer 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. Epub 2020 Mar 20.
- Results publication: PubMed 26292616Tetreau 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.
- Results publication: PubMed 22146976Spiliopoulos 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 Radiol. 2012 Dec;35(6):1315-25. doi: 10.1007/s00270-011-0312-x. Epub 2011 Dec 7.
- Results publication: PubMed 24519028Pang 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.
- Results publication: PubMed 21620671Marone 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.
- Results publication: PubMed 32553135Barrionuevo 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Chieh Yeh, M.D. principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failure in Endovascular Therapy and Splanchnic Aneurysm, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival outcomes after surgical intervention (time frame: From surgical intervention to the latest follow-up date (i.e., 2023-Jan-20)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05727956, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.