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Clinical Trials/NCT04911634
NCT04911634UnknownNot Applicable

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

Odense University Hospital1 site in 1 country20 target enrollmentStarted: January 1, 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
1
Primary Endpoint
Tumor localization

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Complications(12 months)
  • Final diagnosis(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Bau Mortensen

Professor, MD, PhD, DMSc

Odense University Hospital

Study Sites (1)

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