Laparoscopic Versus Open Distal Pancreatectomy for Pancreatic Cancer: a Multicenter Randomized Controlled Trial
Multicenter Prospective Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Distal Pancreatectomy for Ductal Adenocarcinoma of the Pancreatic Body and Tail
1 other identifier
interventional
244
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2019
CompletedStudy Start
First participant enrolled
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedSeptember 21, 2022
September 1, 2022
6.5 years
May 17, 2019
September 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2 year survival
Overall survival at 2 years after surgery
2 years
Study Arms (2)
Laparoscopic distal pancreatectomy
EXPERIMENTALPatients receiving laparoscopic distal pancreatectomy for pancreatic tail and body cancer
open distal pancreatectomy
ACTIVE COMPARATORPatients receiving open distal pancreatectomy for pancreatic tail and body cancer
Interventions
Laparoscopic resection of the diseased portion of the pancreas for treatment of pancreatic cancer
Open resection of the diseased portion of the pancreas for treatment of pancreatic cancer
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features
- Patients with resectable pancreatic cancer at the time of surgery (Including borderline resectable pancreatic cancer at the time of diagnosis or Locally advanced pancreatic cancer after chemotherapy or radiation therapy)
- Lesion (within pancreatic body and tail) is located to the left of the left branch of the hepatic portal vein
- No remote metastasis in preoperative imaging and not adjacent to the superior mesenteric vein, superior mesenteric artery, and abdominal artery
- Patients without invasion of adjacent organs other than the left adrenal gland and mesocolon
- Patients with informed consent
You may not qualify if:
- Patients with remote metastasis at the time of diagnosis of pancreatic cancer
- History of other malignancy (Inclusive if there is no evidence of recurrence after 5 years of treatment)
- In the case of invasion of other organs other than the left adrenal gland and mesocolon
- Where major vascular resection, such as the portal vein or abdominal artery, is required to secure negative resection
- Recurrent pancreatic cancer
- Patients with underlying diseases at high risk of general anesthesia
- Preperitoneal or other organ metastases found during surgery
- In case of previously undergone pancreatic resection
- Other subject whom the investigator deems inappropriate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Seoul National University Bundang Hospitalcollaborator
- Severance Hospitalcollaborator
- Asan Medical Centercollaborator
- Seoul St. Mary's Hospitalcollaborator
- Samsung Medical Centercollaborator
- Gangnam Severance Hospitalcollaborator
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Kyeonggi-do, 13620, South Korea
Related Publications (3)
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.
PMID: 25005018BACKGROUNDYoon 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.
PMID: 19434700BACKGROUNDShin 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.
PMID: 25529901BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ho-Seong Han, M.D. Ph.D.
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 17, 2019
First Posted
May 21, 2019
Study Start
May 20, 2019
Primary Completion
November 30, 2025
Study Completion
November 30, 2025
Last Updated
September 21, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share