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

• Conditions: Laparoscopic Ultrasound

• Registration Number: NCT04911634
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-01
• Status Verified: 2020-05
• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Last Update Submitted: 2021-05-28
• Primary Completion: 2021-05-30
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor localization	12 months	Positive LUS localization of the tumor(s) in minimum 15 patients
LUS guided resection	12 months	A complete LUS guided resection in minimum 15 patients

Secondary Outcome Measures

Name	Time	Method
Complications	12 months	No clinical important complications (Dindo-Clavien ≥3) in any of the patients where LUS guided resection was performed and completed
Final diagnosis	12 months	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

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense C, Denmark