Splenic Artery AneurysmPhase 3NCT01387828
Comparison Between Open and Laparoscopic Splenic Aneurysms Repair
A Phase 3 study testing Laparoscopic splenic aneurysm repair, eventual splenectomy and Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy in people with Splenic Artery Aneurysm, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Splenic Artery Aneurysm
- What is being tested?
- Laparoscopic splenic aneurysm repair, eventual splenectomy and Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2001to Apr 2011
- Phase
- Phase 3
- 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
Who may be able to join
- Splenic artery aneurysm with diameter greater than 2 cm
- Splenic artery aneurysm with diameter smaller than 2 cm if risk factors for rupture are associated (child bearing age, pregnancy, blister or saccular shape, increasing diameter)
Who cannot join
- Complex aneurysm involving the celiac trunk
- American Society of Anesthesiologists (ASA) Score > 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study
The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach.
Read the detailed description
Laparoscopy has not spread into vascular surgery as it has in other surgical branches and still remains in the hands of a minority of surgeons. Splenic artery aneurysm (SAA) is an exception to the rule: an easy-to-reach position and relatively safe control favour the progressive diffusion of laparoscopic techniques.
An increasing number of cases is managed by minimally invasive surgery originating a number of case reports and small series published in recent literature. These papers are unanimous in signalling the feasibility, safety and effectiveness of laparoscopic technique as well as its appreciation by patients -often young females- who harbour the disease. However, perplexities still remain concerning the real potential of laparoscopy in this specific field, in particular considering the spectrum of technical solutions to be performed, the splenectomy rate and the feasibility and results of reconstructive surgery.
The low incidence of the disease justifies the low number of published laparoscopic series enrolling an adequate number of patients and, in particular, the absence of papers comparing open and laparoscopic techniques.
This study reports the first prospective randomized comparison of the different surgical techniques.
- Conditions
- Splenic Artery Aneurysm
- Being tested
- Laparoscopic splenic aneurysm repair, eventual splenectomy, Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy
- Keywords
- Splenic artery, Aneurysm, laparoscopic, Vascular reconstruction, Splenectomy
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic splenic aneurysm repair, eventual splenectomyProcedure or surgery
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach
Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomyProcedure or surgery
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy | Active comparator | Includes all patient underwent intervention with a laparoscopic approach, even if converted to open surgery during intervention Receives: Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy |
| Open surgery | Active comparator | Includes all the patients underwent intervention with a laparotomic approach; it does not include patient underwent laparoscopic approach and then converted in laparotomy. Receives: Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall postoperative morbidity rate
According to Dindo-Clavien classification of postoperative complication, we collect in a prospective way and classify all the possible complication by direct clinical evaluation and additional blood sample, imaging or endoscopy if required.
Measured: During and after hospital stay, an expected average of 50 months
Secondary outcomes (3)
Resumption of oral diet
Time between the intervention and patient oral intake without problems
Measured: Partcipants will be followed for the duration of hospital stay, an expected average of one week
Intra-abdominal surgical drain removal time
Time between intervention and removal of surgical drain
Measured: Partcipants will be followed for the duration of hospital stay, an expected average of one week
Hospital stay length
Time between intervention and discharge
Measured: Partcipants will be followed for the duration of hospital stay, an expected average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJan 2001
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Splenic Artery AneurysmStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Investigators
- Guido AM Tiberio, MD, Principal investigator, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387828
- Sponsor's protocol ID
- AOB 01-11
- Status last verified
- Jun 2011
- First submitted
- 1 Jul 2011
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ha JF, Sieunarine K. Laparoscopic splenic artery aneurysm resection: review of current trends in management. Surg Laparosc Endosc Percutan Tech. 2009 Apr;19(2):e67-70. doi: 10.1097/SLE.0b013e31819bd4e7.
PubMed 19390269Arca MJ, Gagner M, Heniford BT, Sullivan TM, Beven EG. Splenic artery aneurysms: methods of laparoscopic repair. J Vasc Surg. 1999 Jul;30(1):184-8. doi: 10.1016/s0741-5214(99)70190-4.
PubMed 10394168Pietrabissa A, Ferrari M, Berchiolli R, Morelli L, Pugliese L, Ferrari V, Mosca F. Laparoscopic treatment of splenic artery aneurysms. J Vasc Surg. 2009 Aug;50(2):275-9. doi: 10.1016/j.jvs.2009.03.015.
PubMed 19631859Suzuki H, Shimura T, Asao T, Nomoto K, Kanoh K, Tuboi K, Wada S, Kuwano H. Laparoscopic resection of splenic artery aneurysm; a case report. Hepatogastroenterology. 2002 Nov-Dec;49(48):1520-2.
PubMed 12397723Obuchi T, Sasaki A, Nakajima J, Nitta H, Otsuka K, Wakabayashi G. Laparoscopic surgery for splenic artery aneurysm. Surg Laparosc Endosc Percutan Tech. 2009 Aug;19(4):338-40. doi: 10.1097/SLE.0b013e3181a89206.
PubMed 19692887Reardon PR, Otah E, Craig ES, Matthews BD, Reardon MJ. Laparoscopic resection of splenic artery aneurysms. Surg Endosc. 2005 Apr;19(4):488-93. doi: 10.1007/s00464-004-8916-8. Epub 2005 Feb 3.
PubMed 15959711de Csepel J, Quinn T, Gagner M. Laparoscopic exclusion of a splenic artery aneurysm using a lateral approach permits preservation of the spleen. Surg Laparosc Endosc Percutan Tech. 2001 Jun;11(3):221-4.
PubMed 11444759Sandford RM, Lloyd DM, Ross Naylor A. Laparoscopic ligation of splenic artery aneurysm. Surg Laparosc Endosc Percutan Tech. 2006 Apr;16(2):102-3. doi: 10.1097/00129689-200604000-00010.
PubMed 16773011Adham M, Blanc P, Douek P, Henri L, Ducerf C, Baulieux J. Laparoscopic resection of a proximal splenic artery aneurysm. Surg Endosc. 2000 Apr;14(4):372. doi: 10.1007/s004640010051.
PubMed 10854524Meinke AK, Floch NR, Dicorato MP. Laparoscopic options in the treatment of splenic artery aneurysms. Surg Endosc. 2002 Jul;16(7):1107. doi: 10.1007/s00464-002-0003-4. Epub 2002 May 3.
PubMed 11984676Mastracci TM, Cadeddu M, Colopinto RF, Cina C. A minimally invasive approach to the treatment of aberrant splenic artery aneurysms: a report of two cases. J Vasc Surg. 2005 Jun;41(6):1053-7. doi: 10.1016/j.jvs.2005.01.056.
PubMed 15944609Holdsworth RJ, Gunn A. Ruptured splenic artery aneurysm in pregnancy. A review. Br J Obstet Gynaecol. 1992 Jul;99(7):595-7. doi: 10.1111/j.1471-0528.1992.tb13828.x. No abstract available.
PubMed 1525102Ha JF, Phillips M, Faulkner K. Splenic artery aneurysm rupture in pregnancy. Eur J Obstet Gynecol Reprod Biol. 2009 Oct;146(2):133-7. doi: 10.1016/j.ejogrb.2009.05.034. Epub 2009 Jul 10.
PubMed 19596508Abbas MA, Stone WM, Fowl RJ, Gloviczki P, Oldenburg WA, Pairolero PC, Hallett JW, Bower TC, Panneton JM, Cherry KJ. Splenic artery aneurysms: two decades experience at Mayo clinic. Ann Vasc Surg. 2002 Jul;16(4):442-9. doi: 10.1007/s10016-001-0207-4. Epub 2002 Jul 1.
PubMed 12089631Jung SI, Joh YG, Um JW, Suh SO, Whang CW, Corbascio M. The Seoul experience of splenic artery aneurysms. Ann Chir Gynaecol. 2001;90(1):10-4.
PubMed 11336361
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study
- ClinicalTrials.gov ID
- NCT01387828
- Acronym / sponsor ID
- AOB 01-11
- Conditions
- Splenic Artery Aneurysm
- Keywords
- Splenic artery, Aneurysm, laparoscopic, Vascular reconstruction, Splenectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 6 Jul 2011 (estimated)
- 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.
The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach.
Detailed description
Laparoscopy has not spread into vascular surgery as it has in other surgical branches and still remains in the hands of a minority of surgeons. Splenic artery aneurysm (SAA) is an exception to the rule: an easy-to-reach position and relatively safe control favour the progressive diffusion of laparoscopic techniques.
An increasing number of cases is managed by minimally invasive surgery originating a number of case reports and small series published in recent literature. These papers are unanimous in signalling the feasibility, safety and effectiveness of laparoscopic technique as well as its appreciation by patients -often young females- who harbour the disease. However, perplexities still remain concerning the real potential of laparoscopy in this specific field, in particular considering the spectrum of technical solutions to be performed, the splenectomy rate and the feasibility and results of reconstructive surgery.
The low incidence of the disease justifies the low number of published laparoscopic series enrolling an adequate number of patients and, in particular, the absence of papers comparing open and laparoscopic techniques.
This study reports the first prospective randomized comparison of the different surgical techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy | Active comparator | Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomyIncludes all patient underwent intervention with a laparoscopic approach, even if converted to open surgery during intervention |
| Open surgery | Active comparator | Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomyIncludes all the patients underwent intervention with a laparotomic approach; it does not include patient underwent laparoscopic approach and then converted in laparotomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Splenic artery aneurysm with diameter greater than 2 cm
- Splenic artery aneurysm with diameter smaller than 2 cm if risk factors for rupture are associated (child bearing age, pregnancy, blister or saccular shape, increasing diameter)
Key exclusion criteria (2 listed)
- Complex aneurysm involving the celiac trunk
- American Society of Anesthesiologists (ASA) Score > 3
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 |
|---|---|---|
| Laparoscopic splenic aneurysm repair, eventual splenectomyAneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach | Procedure or surgery | Laparoscopy |
| Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomyAneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach | Procedure or surgery | Open surgery |
Primary outcome
Overall postoperative morbidity rate
Time frame: During and after hospital stay, an expected average of 50 months
According to Dindo-Clavien classification of postoperative complication, we collect in a prospective way and classify all the possible complication by direct clinical evaluation and additional blood sample, imaging or endoscopy if required.
3 secondary outcomes
Resumption of oral diet
Time frame: Partcipants will be followed for the duration of hospital stay, an expected average of one week
Intra-abdominal surgical drain removal time
Time frame: Partcipants will be followed for the duration of hospital stay, an expected average of one week
Hospital stay length
Time frame: Partcipants will be followed for the duration of hospital stay, an expected average of one week
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 7 Jul 2011.
- Background: PubMed 19390269Ha JF, Sieunarine K. Laparoscopic splenic artery aneurysm resection: review of current trends in management. Surg Laparosc Endosc Percutan Tech. 2009 Apr;19(2):e67-70. doi: 10.1097/SLE.0b013e31819bd4e7.
- Background: PubMed 10394168Arca MJ, Gagner M, Heniford BT, Sullivan TM, Beven EG. Splenic artery aneurysms: methods of laparoscopic repair. J Vasc Surg. 1999 Jul;30(1):184-8. doi: 10.1016/s0741-5214(99)70190-4.
- Background: PubMed 19631859Pietrabissa A, Ferrari M, Berchiolli R, Morelli L, Pugliese L, Ferrari V, Mosca F. Laparoscopic treatment of splenic artery aneurysms. J Vasc Surg. 2009 Aug;50(2):275-9. doi: 10.1016/j.jvs.2009.03.015.
- Background: PubMed 12397723Suzuki H, Shimura T, Asao T, Nomoto K, Kanoh K, Tuboi K, Wada S, Kuwano H. Laparoscopic resection of splenic artery aneurysm; a case report. Hepatogastroenterology. 2002 Nov-Dec;49(48):1520-2.
- Background: PubMed 19692887Obuchi T, Sasaki A, Nakajima J, Nitta H, Otsuka K, Wakabayashi G. Laparoscopic surgery for splenic artery aneurysm. Surg Laparosc Endosc Percutan Tech. 2009 Aug;19(4):338-40. doi: 10.1097/SLE.0b013e3181a89206.
- Background: PubMed 15959711Reardon PR, Otah E, Craig ES, Matthews BD, Reardon MJ. Laparoscopic resection of splenic artery aneurysms. Surg Endosc. 2005 Apr;19(4):488-93. doi: 10.1007/s00464-004-8916-8. Epub 2005 Feb 3.
- Background: PubMed 11444759de Csepel J, Quinn T, Gagner M. Laparoscopic exclusion of a splenic artery aneurysm using a lateral approach permits preservation of the spleen. Surg Laparosc Endosc Percutan Tech. 2001 Jun;11(3):221-4.
- Background: PubMed 16773011Sandford RM, Lloyd DM, Ross Naylor A. Laparoscopic ligation of splenic artery aneurysm. Surg Laparosc Endosc Percutan Tech. 2006 Apr;16(2):102-3. doi: 10.1097/00129689-200604000-00010.
- Background: PubMed 10854524Adham M, Blanc P, Douek P, Henri L, Ducerf C, Baulieux J. Laparoscopic resection of a proximal splenic artery aneurysm. Surg Endosc. 2000 Apr;14(4):372. doi: 10.1007/s004640010051.
- Background: PubMed 11984676Meinke AK, Floch NR, Dicorato MP. Laparoscopic options in the treatment of splenic artery aneurysms. Surg Endosc. 2002 Jul;16(7):1107. doi: 10.1007/s00464-002-0003-4. Epub 2002 May 3.
- Background: PubMed 15944609Mastracci TM, Cadeddu M, Colopinto RF, Cina C. A minimally invasive approach to the treatment of aberrant splenic artery aneurysms: a report of two cases. J Vasc Surg. 2005 Jun;41(6):1053-7. doi: 10.1016/j.jvs.2005.01.056.
- Background: PubMed 1525102Holdsworth RJ, Gunn A. Ruptured splenic artery aneurysm in pregnancy. A review. Br J Obstet Gynaecol. 1992 Jul;99(7):595-7. doi: 10.1111/j.1471-0528.1992.tb13828.x. No abstract available.
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Splenic Artery Aneurysm, Immune Function
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.
Guido AM Tiberio, MD principal investigator
Università degli Studi di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopic splenic aneurysm repair, eventual splenectomy and Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy in people with Splenic Artery Aneurysm, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
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 7 Jul 2011. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overall postoperative morbidity rate (time frame: During and after hospital stay, an expected average of 50 months). 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 NCT01387828, which also lists 23 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 7 Jul 2011.