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

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 Overview

• Status: Unknown
• Conditions: Laparoscopic Ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Michael B Mortensen; Phone Number: +4529694638; Email: michael.bau.mortensen@rsyd.dk

Study Locations

• Denmark
  • Odense C, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Michael B Mortensen, MD, PhD; Phone Number: 45 6541 1857; Email: michael.bau.mortensen@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor localization	Positive LUS localization of the tumor(s) in minimum 15 patients	12 months
LUS guided resection	A complete LUS guided resection in minimum 15 patients	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	No clinical important complications (Dindo-Clavien ≥3) in any of the patients where LUS guided resection was performed and completed	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	12 months

Collaborators and Investigators

• Sponsor: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2005
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MBM-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO