Laparoscopic UltrasoundNCT04911634
Laparoscopic Ultrasound Guided Minimal Invasive Excision of Intra-/Retroperitoneal Tumors
An observational study of Laparoscopic Ultrasound, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Patients included in the study went through standard preoperative preparation and were informed about potential conversion to open surgery. The procedure started with LUS performed according to the department's standard guidelines (one twelve mm trocar in the midline and one 12 mm trocar in the left upper quadrant)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Ultrasound
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2005to 30 Jun 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients were discussed at the Upper or Lower GI Multidisciplinary Team conferences MDT in order to make sure that only patients where explorative laparotomy was considered the next and only possible clinical step, were referred for the minimal invasive procedure.
Who may be able to join
- Patients with intra- and retroperitoneal tumor(s) (IRT) detected by imaging (US/CTMR/PET or EUS) and a clinical indication for explorative laparotomy
Who cannot join
- Patients with contraindications for laparoscopy, such as severe adherences were excluded
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense C, 5000
Michael B Mortensen, MD, PhD, 45 6541 1857, michael.bau.mortensen@rsyd.dk
About this study
Official title: Laparoscopic Ultrasound Guided Minimal Invasive Excision of Intra-/Retroperitoneal Tumors in Patients Scheduled for Laparotomy: A Pilot Study
Patients included in the study went through standard preoperative preparation and were informed about potential conversion to open surgery. The procedure started with LUS performed according to the department's standard guidelines (one twelve mm trocar in the midline and one 12 mm trocar in the left upper quadrant) followed by a stepwise scanning of relevant structures (e.g. liver, pancreas, retroperitoneum) with dedicated laparoscopic ultrasound equipment (BK Medical, Herlev, Denmark). If the suspected lesion(s) was detected by LUS in the relevant area (according to preoperative imaging), laparoscopic resection was attempted, and if successful the specimen was removed in an eEndo-bBag (Kebomed, Denmark) through one of the trocars. A second LUS was performed to ensure that no tumor was left behind ("loss-of-lesion(s)").
If any problem occurred during the laparoscopic procedure, the operation was converted to an open procedure. Prophylactic antibiotics were not given routinely but were administered during surgery at the surgeons' discretion.
The intra- and postoperative course and final clinical outcome including pathology reports were retrieved from the patient's electronical records. This included a postoperative follow up of at least 12 months to investigate potential incomplete resection. Postoperative complications were graded according to Dindo-Clavien (17). The pathology reports were retrieved from the Danish Pathology Registry.
- Conditions
- Laparoscopic Ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor localization
Positive LUS localization of the tumor(s) in minimum 15 patients
Measured: 12 months
LUS guided resection
A complete LUS guided resection in minimum 15 patients
Measured: 12 months
Secondary outcomes (2)
Complications
No clinical important complications (Dindo-Clavien ≥3) in any of the patients where LUS guided resection was performed and completed
Measured: 12 months
Final diagnosis
A pathological diagnosis was obtained based on the resected tumor(s) in all cases. The LUS guided procedure should obviate the need for (subsequent) open surgery in all patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jan 2005
- Primary completion30 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic UltrasoundStudies of the same condition, open and under way.
- More trials run by Odense 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Bau Mortensen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911634
- Sponsor's protocol ID
- MBM-41
- Status last verified
- May 2020
- First submitted
- 28 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Ultrasound Guided Minimal Invasive Excision of Intra-/Retroperitoneal Tumors in Patients Scheduled for Laparotomy: A Pilot Study
- ClinicalTrials.gov ID
- NCT04911634
- Acronym / sponsor ID
- MBM-41
- Conditions
- Laparoscopic Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 3 Jun 2021 (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.
Patients included in the study went through standard preoperative preparation and were informed about potential conversion to open surgery. The procedure started with LUS performed according to the department's standard guidelines (one twelve mm trocar in the midline and one 12 mm trocar in the left upper quadrant) followed by a stepwise scanning of relevant structures (e.g. liver, pancreas, retroperitoneum) with dedicated laparoscopic ultrasound equipment (BK Medical, Herlev, Denmark). If the suspected lesion(s) was detected by LUS in the relevant area (according to preoperative imaging), laparoscopic resection was attempted, and if successful the specimen was removed in an eEndo-bBag (Kebomed, Denmark) through one of the trocars. A second LUS was performed to ensure that no tumor was left behind ("loss-of-lesion(s)").
If any problem occurred during the laparoscopic procedure, the operation was converted to an open procedure. Prophylactic antibiotics were not given routinely but were administered during surgery at the surgeons' discretion.
The intra- and postoperative course and final clinical outcome including pathology reports were retrieved from the patient's electronical records. This included a postoperative follow up of at least 12 months to investigate potential incomplete resection. Postoperative complications were graded according to Dindo-Clavien (17). The pathology reports were retrieved from the Danish Pathology Registry.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were discussed at the Upper or Lower GI Multidisciplinary Team conferences MDT in order to make sure that only patients where explorative laparotomy was considered the next and only possible clinical step, were referred for the minimal invasive procedure.
Key inclusion criteria (1 listed)
- Patients with intra- and retroperitoneal tumor(s) (IRT) detected by imaging (US/CTMR/PET or EUS) and a clinical indication for explorative laparotomy
Key exclusion criteria (1 listed)
- Patients with contraindications for laparoscopy, such as severe adherences were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor localization
Time frame: 12 months
Positive LUS localization of the tumor(s) in minimum 15 patients
LUS guided resection
Time frame: 12 months
A complete LUS guided resection in minimum 15 patients
2 secondary outcomes
Complications
Time frame: 12 months
Final diagnosis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
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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.
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 Laparoscopic Ultrasound, run by Odense University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jun 2021. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Mortensen (+4529694638, michael.bau.mortensen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor localization (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2021.