Comparison of laparoscopic and open distal pancreatectomy

RCT-Laparoscopic vs open distal pancreatectomy in an unselected patient cohort

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26912858

Enrollment

Registered

2015-09-28

Start date

2015-10-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Pancreatic tumors Cancer

Interventions

Two arms: 1. Laparoscopic distal pancreatectomy 2. Open distal pancreatectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with lesion in the body or tail of the pancreas demanding surgery (indication set by multidisciplinary conference) 2. Operable patient (as the local preoperatively evaluation dictates) 3. Possibility to achieve R0-resection without resection of additional organs (besides the spleen) 4. Patients with performance status 0-2 according to WHO scale 5. Written informed consent. 6. Age > 18 years

Exclusion criteria

Exclusion criteria: 1. Pregnancy and/or lactation 2. Patients being unable to comply with the protocol for reasons of language or cognitive function 3. Preoperatively defined need to resect other organs than pancreas and spleen 4. Preoperatively defined division line of pancreas to the right of the SMV

Design outcomes

Primary

Measure	Time frame
Length of stay in hospital after laparoscopic- and open distal pancreatectomy	—

Secondary

Measure	Time frame
1. To compare perioperative bleeding during LDP and ODP, measured after operation 2. To compare postoperative pain after LDP and ODP, measured 3 times/day during hospital stay with Visual analouge scale 3. To compare the use of analgetics after LDP and ODP, measured at discharge, amount of drugs given 4. To evaluate quality of life postoperatively after LDP and ODP, measured 5-6 weeks postoperatively as well as 6, 12 and 24 months after operation. Tools for measurement: EORTC QLQ-C30 to which is added the PAN26 module and EQ-5D. 5. To analyze costs associated with LDP and ODP. Measured as direct (hospital cost) after discharge a combination of actual cost and schablon is used 6. To compare complications in LDP and ODP measured up to 90 Days after operation according to Clavien-Dindo classification as well as comprehensive complication index 7. To evaluate survival, measured 2 years after operation 8. Oncological quality of resection measured by PAD assessment as number of investigated lymphnodes and tumor marginal in mm	—

Measure

Time frame

1. To compare perioperative bleeding during LDP and ODP, measured after operation 2. To compare postoperative pain after LDP and ODP, measured 3 times/day during hospital stay with Visual analouge scale 3. To compare the use of analgetics after LDP and ODP, measured at discharge, amount of drugs given 4. To evaluate quality of life postoperatively after LDP and ODP, measured 5-6 weeks postoperatively as well as 6, 12 and 24 months after operation. Tools for measurement: EORTC QLQ-C30 to which is added the PAN26 module and EQ-5D. 5. To analyze costs associated with LDP and ODP. Measured as direct (hospital cost) after discharge a combination of actual cost and schablon is used 6. To compare complications in LDP and ODP measured up to 90 Days after operation according to Clavien-Dindo classification as well as comprehensive complication index 7. To evaluate survival, measured 2 years after operation 8. Oncological quality of resection measured by PAD assessment as number of investigated lymphnodes and tumor marginal in mm

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Countries

Sweden

Contacts

Public ContactBergthor Björnsson

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026