Distal Pancreatectomy A randomized controlled trial to compare two different surgical techniques

Conditions: leftsided resection pancreas
10015674

Registration Number: NL-OMON30759

Lead Sponsor: Chirurgische Universitätsklinik Heidelberg Duitsland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

· Age equal or above 18 years
· Expected survival time more than 12 months
· Patients with at least one of the following pathologic diseases scheduled for
elective resection:
- Resectable malignancies of the pancreatic body and/or tail
- Resectable chronic pancreatitis of the body and/or tail
- Resectable benign tumours of the pancreas including neuroendocrine tumours
- Resectable pseudocyst of the pancreatic body and/or tail

Exclusion Criteria

· Current immunosuppressive therapy
· Chemotherapy within 2 weeks before operation
· Radiotherapy within 8 weeks before operation
· Curative resection is not feasible
· Severe psychiatric or neurologic diseases
· Drug- and/or alcohol-abuse according to local standards
· Participation in another intervention-trial with interference of intervention or
outcome
· Inability to follow the instructions given by the investigator or interviewer
· Expected lack of compliance
· Lack of informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Combined primary endpoint:<br /><br>· Occurence of a pancreatic fistula.<br /><br>· Death due to any cause until the postoperative day 7.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Surgical category<br /><br>· Operating time [min] from resection to beginning of closure of the abdomen<br /><br>· Total operating time [min]<br /><br>· Frequency of burst abdomen<br /><br>· Frequency of wound infection<br /><br>· Frequency of intra-abdominal fluid collection rated as abscess that requires<br /><br>an intervention<br /><br>(surgery, drainage, antibiotic treatment)<br /><br>2. Non-surgical category<br /><br>· postoperative length of hospital stay<br /><br>· Frequency of new onset diabetes mellitus (necessity of new anti-diabetic drug<br /><br>treatment)<br /><br>· One-year survival</p><br>