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

A randomised trial to compare postoperative and pathologic results between open and laparoscopic approach for pancreaticoduodenectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93168938

Enrollment

Registered

2013-08-05

Start date

2013-01-01

Completion date

Unknown

Last updated

2019-09-16

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

Conditions

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

Interventions

Patients who have to be operated of PD will be randomised in two groups, laparoscopic and open approach. Open randomisation has been done using an informatic programme. The duration o

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.)

Design outcomes

Primary

Measure	Time frame
Lenght of stay: days (a day will be considered as a night spent in the hospital)	—

Secondary

Measure	Time frame
1. Global complications (Claviens classification of surgical complications adopted for pancreatic surgery) - At 30, 60 and 90 days 2. Severe complications (grades >II in the Clavien¡¯s classification of surgical complications adopted for pancreatic surgery) - At 30, 60 and 90 days 3. Specific complication related to pancreatic surgery (pancreatic fistula, delayed gastric emptying, post-pancreatectomy haemorrhage) - At 30, 60 and 90 days 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. 5. Oncologic results attending to the quality of the resected specimen (lymph nodes harvested, margins affected) 6. Cost/benefit study. From the beginning of the operation until the day of discharge.	—

Measure

Time frame

1. Global complications (Claviens classification of surgical complications adopted for pancreatic surgery) - At 30, 60 and 90 days 2. Severe complications (grades >II in the Clavien¡¯s classification of surgical complications adopted for pancreatic surgery) - At 30, 60 and 90 days 3. Specific complication related to pancreatic surgery (pancreatic fistula, delayed gastric emptying, post-pancreatectomy haemorrhage) - At 30, 60 and 90 days 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. 5. Oncologic results attending to the quality of the resected specimen (lymph nodes harvested, margins affected) 6. Cost/benefit study. From the beginning of the operation until the day of discharge.

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Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026