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

Recruiting

Conditions: 10017990
10017998
pancreasaandoeningen/pancreastumoren
cancer
tumor

Registration Number: NL-OMON45123

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 102

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

* 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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