Laparoscopic versus open distal pancreatectomy for symptomatic benign, premalignant and malignant disease

Laparoscopic versus open distal pancreatectomy for symptomatic benign, premalignant and malignant disease - LEOPARD trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45123

Enrollment

102

Registered

2015-03-12

Start date

2015-04-09

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

pancreasaandoeningen/pancreastumoren cancer tumor

Interventions

Intervention: Laparoscopic distal pancreatectomy (+ / - splenectomy). Control: Open distal pancreatectomy (+ / - splenectomy).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age equal or above 18 years; * Indication for elective distal pancreatectomy (+ / - splenectomy) because of proven or suspected symptomatic benign, premalignant or malignant disease of the distal pancreas (as defined in section 4.4); * Tumor meeting the Yonsei criteria33: * Fit to undergo distal pancreatectomy according to the surgeon and anaesthetist.

Exclusion criteria

Exclusion criteria: * Tumor or cyst larger than 8 cm; * Distal pancreatectomy is not the sole procedure, so when a surgical intervention (resection / ablation) of other organs besides the distal pancreas or spleen is performed (minor procedures, such as cholecystectomy, are allowed); * Chronic pancreatitis (according to the M-ANNHEIM criteria, see Appendix 2 for detailed definition); * Previous radiotherapy for pancreatic cancer; * Pregnancy; * Participation in another study with interference of study outcomes.

Design outcomes

Primary

Measure	Time frame
Primary outcome is the time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication only, ability to maintain sufficient (> 50%) daily required caloric intake, no intravenous fluid administration and no signs of infection.	—

Secondary

Measure	Time frame
Main secondary outcome is the occurrence of major complications (i.e. Clavien-Dindo score of III or higher). Other secondary outcomes are I)intraoperative parameters such as splenectomy, conversion, operating time, blood loss and transfusion, II)postoperative outcomes such as complications, intensive care admission, length of hospital stay and readmission and III)pathology outcomes such as resection margin status and number of lymph nodes resected.	—

Measure

Time frame

Main secondary outcome is the occurrence of major complications (i.e. Clavien-Dindo score of III or higher). Other secondary outcomes are I)intraoperative parameters such as splenectomy, conversion, operating time, blood loss and transfusion, II)postoperative outcomes such as complications, intensive care admission, length of hospital stay and readmission and III)pathology outcomes such as resection margin status and number of lymph nodes resected.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)