Laparoscopic Versus Open Distal Pancreatectomy for Pancreatic Cancer: a Multicenter Randomized Controlled Trial
Study Details
Study Description
Brief Summary
When pancreatic cancer of the body and tail is diagnosed, a distal pancreatectomy is planned. This operation can be performed with open surgery, or with laparoscopic surgery. This study is a multicenter randomized controlled trial to evaluate the operative outcomes and survival of open versus laparoscopic distal pancreatectomy for pancreatic cancer of the body and tail.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
- Purpose
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- 2 year survival [2 years]
Overall survival at 2 years after surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features
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No evidence of distant metastasis
-
No direct invasion of adjacent structures, with the exception of mesocolon or left adrenal gland
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Possible to achieve a negative margin from adjacent major vasculature (Common hepatic artery, superior mesenteric artery, celiac axis, superior mesenteric vein - portal vein)
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Eastern Cooperative Oncology Group (ECOG) performance score 0-2
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Patients with informed consent
Exclusion Criteria:
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History of other malignancy (with the exception of more than 5 year interval, with no evidence of recurrence)
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Necessity of resection of other abdominal organs
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Recurrent pancreatic cancer
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Neoadjuvant chemotherapy
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Comorbidities with a high risk for general anesthesia
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Other subject whom the investigator deems inappropriate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Bundang Hospital | Seongnam-si | Kyeonggi-do | Korea, Republic of | 13620 |
Sponsors and Collaborators
- Seoul National University Hospital
- Seoul National University Bundang Hospital
- Severance Hospital
- Asan Medical Center
- Seoul St. Mary's Hospital
Investigators
- Principal Investigator: Ho-Seong Han, M.D. Ph.D., Seoul National University Bundang Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Shin SH, Kim SC, Song KB, Hwang DW, Lee JH, Lee D, Lee JW, Jun E, Park KM, Lee YJ. A comparative study of laparoscopic vs. open distal pancreatectomy for left-sided ductal adenocarcinoma: a propensity score-matched analysis. J Am Coll Surg. 2015 Feb;220(2):177-85. doi: 10.1016/j.jamcollsurg.2014.10.014. Epub 2014 Oct 31.
- Yoon YS, Lee KH, Han HS, Cho JY, Ahn KS. Patency of splenic vessels after laparoscopic spleen and splenic vessel-preserving distal pancreatectomy. Br J Surg. 2009 Jun;96(6):633-40. doi: 10.1002/bjs.6609.
- Yoon YS, Lee KH, Han HS, Cho JY, Jang JY, Kim SW, Lee WJ, Kang CM, Park SJ, Han SS, Ahn YJ, Yu HC, Choi IS. Effects of laparoscopic versus open surgery on splenic vessel patency after spleen and splenic vessel-preserving distal pancreatectomy: a retrospective multicenter study. Surg Endosc. 2015 Mar;29(3):583-8. doi: 10.1007/s00464-014-3701-9. Epub 2014 Jul 9.
- SNUBH-GS-HBP4