PADULAP study: To compare postoperative and pathologic results between open and laparoscopic approach for pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Patients who require a pancreaticoduodenectomy as a surgical intervention for the radical treatment of their disease; Surgery

• Registration Number: ISRCTN93168938
• Lead Sponsor: Hospital del Mar (Spain)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30138162

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-05
• Study Completion: 2017-12-31
• Last Update Posted: 16 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1.>=18 years, both sex
2. Patients who have a benign, premalignant or malignant disease in the head of the pancreas, periampulary area or bilio-pancreatic confluent, who require a pancreatico-duodenectomy as the standard treatment for surgical resection.

Exclusion Criteria

1. Pregnancy
2. Tumour involvement of the portal or mesenteric vein requiring vascular resection with vascular reconstruction
3. Clearly hostile abdomen for laparoscopic surgery (multiples previous laparotomies, incisional hernias, complex previous upper GI surgery)
4. Previous chronic disease that can contraindicate the laparoscopic approach (cirrhosis, severe pulmonary disease, etc.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
enght of stay: days (a day will be considered as a night spent in the hospital)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Global complications (Claviens classification of surgical complications adopted for pancreatic surgery) - At 30, 60 and 90 days<br> 2. Severe complications (grades >II in the Clavien¡¯s classification of surgical complications adopted for pancreatic surgery) - At 30, 60 and 90 days<br> 3. Specific complication related to pancreatic surgery (pancreatic fistula, delayed gastric emptying, post-pancreatectomy haemorrhage) - At 30, 60 and 90 days<br> 4. Blood transfusion (peroperative and total stay) - Peroperative: first 24 h. from the beginning of the surgery, includes intraoperative transfusion. Total: all blood requiriments until date of discharge.<br> 5. Oncologic results attending to the quality of the resected specimen (lymph nodes harvested, margins affected)<br> 6. Cost/benefit study. From the beginning of the operation until the day of discharge.<br>