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Laparoscopic Ultrasound Guided Minimal Invasive Excision of Intra-/Retroperitoneal Tumors

Laparoscopic Ultrasound Guided Minimal Invasive Excision of Intra-/Retroperitoneal Tumors in Patients Scheduled for Laparotomy: A Pilot Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04911634
Enrollment
20
Registered
2021-06-03
Start date
2005-01-01
Completion date
2021-06-30
Last updated
2021-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Ultrasound

Brief 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) 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.

Interventions

None listed

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients with intra- and retroperitoneal tumor(s) (IRT) detected by imaging (US/CTMR/PET or EUS) and a clinical indication for explorative laparotomy

Exclusion criteria

Patients with contraindications for laparoscopy, such as severe adherences were excluded

Design outcomes

Primary

MeasureTime frameDescription
Tumor localization12 monthsPositive LUS localization of the tumor(s) in minimum 15 patients
LUS guided resection12 monthsA complete LUS guided resection in minimum 15 patients

Secondary

MeasureTime frameDescription
Complications12 monthsNo clinical important complications (Dindo-Clavien ≥3) in any of the patients where LUS guided resection was performed and completed
Final diagnosis12 monthsA 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

Countries

Denmark

Contacts

Primary ContactMichael B Mortensen
michael.bau.mortensen@rsyd.dk+4529694638

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026