Laparoscopic Versus Open Distal Pancreatectomy for Pancreatic Cancer: a Multicenter Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT03957135|
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : June 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Neoplasm Malignant Resectable||Procedure: Laparoscopic distal pancreatectomy Procedure: open distal pancreatectomy||Not Applicable|
To compare the safety and oncologic feasibility of open versus laparoscopic distal pancreatectomy for the treatment of pancreatic ductal adenocarcinoma (PDAC) of the body and tail.
* Study method
Multicenter prospective randomized controlled trial Noninferiority analysis Patients diagnosed with PDAC of the body and tail, without evidence of distant metastasis or direct invasion of adjacent organs, will be randomly allocated to either the open distal pancreatectomy group or the laparoscopic distal pancreatectomy group. Postoperative outcomes and survival data will be analyzed.
* Number of subjects
Sample size was calculated based on 2 year survival after pancreatectomy.
pA: 2 year survival of open distal pancreatectomy pB: 2 year survival of laparoscopic distal pancreatectomy
Null hypothesis: The 2 year survival of laparoscopic distal pancreatectomy is inferior to that of open distal pancreatectomy. H0: pA−pB≥δ
Alternative hypothesis: The 2 year survival of laparoscopic distal pancreatectomy is not inferior to that of open distal pancreatectomy. H1: pA−pB<δ
2 year survival of pancreatectomy (Shin et al, 2015) is 55.9% for open and 64.3% for laparoscopic distal pancreatectomy.
When α=5%, 1-β=80%, δ=10%, and one-sided analysis is performed with a power of 80%, the required number of subjects is 111 for each group.
With a drop rate of 10%, the final number of each group is 122, with a total of 244.
* Primary and Secondary endpoints
Primary endpoint: 2 year overall survival
Secondary endpoint: R0 resection rate, 2 year disease free survival, 2 year recurrence rate, complication rate, postoperative hospital stay, operative time, estimated blood loss
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||244 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective randomized controlled clinical trial|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Prospective Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Distal Pancreatectomy for Ductal Adenocarcinoma of the Pancreatic Body and Tail|
|Actual Study Start Date :||May 20, 2019|
|Estimated Primary Completion Date :||November 30, 2025|
|Estimated Study Completion Date :||November 30, 2025|
Experimental: Laparoscopic distal pancreatectomy
Patients receiving laparoscopic distal pancreatectomy for pancreatic tail and body cancer
Procedure: Laparoscopic distal pancreatectomy
Laparoscopic resection of the diseased portion of the pancreas for treatment of pancreatic cancer
Active Comparator: open distal pancreatectomy
Patients receiving open distal pancreatectomy for pancreatic tail and body cancer
Procedure: open distal pancreatectomy
Open resection of the diseased portion of the pancreas for treatment of pancreatic cancer
- 2 year survival [ Time Frame: 2 years ]Overall survival at 2 years after surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957135
|Contact: Jun Suh Lee, M.D. Ph.D.||+email@example.com|
|Contact: Yoo-Seok Yoon, M.D. Ph.D.||firstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Bundang Hospital||Recruiting|
|Seongnam-si, Kyeonggi-do, Korea, Republic of, 13620|
|Contact: Jun Suh Lee, M.D., Ph.D. +82-10-2747-6320 email@example.com|
|Principal Investigator: Ho-Seong Han, M.D.,Ph.D.|
|Sub-Investigator: Yoo-Seok Yoon, M.D.,Ph.D.|
|Principal Investigator:||Ho-Seong Han, M.D. Ph.D.||Seoul National University Bundang Hospital|