Pancreas Neoplasm Malignant ResectableNCT03957135
Laparoscopic Versus Open Distal Pancreatectomy for Pancreatic Cancer: a Multicenter Randomized Controlled Trial
A study testing Laparoscopic distal pancreatectomy and open distal pancreatectomy in people with Pancreas Neoplasm Malignant Resectable, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreas Neoplasm Malignant Resectable
- What is being tested?
- Laparoscopic distal pancreatectomy and open distal pancreatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 May 2019to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Preperitoneal or other organ metastases found during surgery
- In case of previously undergone pancreatic resection
- Other subject whom the investigator deems inappropriate
Trial locations and contacts
1 site in 1 country.
Yoo-Seok Yoon, M.D. Ph.D. contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Kyeonggi-do, 13620
Jun Suh Lee, M.D., Ph.D., +82-10-2747-6320, rudestock@gmail.com
Ho-Seong Han, M.D.,Ph.D.
About this study
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
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.
Read the 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
- Conditions
- Pancreas Neoplasm Malignant Resectable
- Being tested
- Laparoscopic distal pancreatectomy, open distal pancreatectomy
- Keywords
- pancreas neoplasms, pancreatectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic distal pancreatectomyProcedure or surgery
Laparoscopic resection of the diseased portion of the pancreas for treatment of pancreatic cancer
open distal pancreatectomyProcedure or surgery
Open resection of the diseased portion of the pancreas for treatment of pancreatic cancer
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic distal pancreatectomy | Experimental | Patients receiving laparoscopic distal pancreatectomy for pancreatic tail and body cancer Receives: Procedure: Laparoscopic distal pancreatectomy |
| open distal pancreatectomy | Active comparator | Patients receiving open distal pancreatectomy for pancreatic tail and body cancer Receives: Procedure: open distal pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year survival
Overall survival at 2 years after surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start20 May 2019
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreas Neoplasm Malignant ResectableStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Severance Hospital, Asan Medical Center, Seoul St. Mary's Hospital, Samsung Medical Center, Gangnam Severance Hospital
- Responsible party
- Principal investigator, Ho-Seong Han, Seoul National University Hospital
- Investigators
- Ho-Seong Han, M.D. Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957135
- Sponsor's protocol ID
- SNUBH-GS-HBP4
- Status last verified
- Sep 2022
- First submitted
- 17 May 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25005018Yoon 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.
PubMed 19434700Shin 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.
PubMed 25529901
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03957135
- Acronym / sponsor ID
- SNUBH-GS-HBP4
- Conditions
- Pancreas Neoplasm Malignant Resectable
- Keywords
- pancreas neoplasms, pancreatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Severance Hospital, Asan Medical Center, Seoul St. Mary's Hospital, Samsung Medical Center, Gangnam Severance Hospital
- Study start
- 20 May 2019 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic distal pancreatectomy | Experimental | Procedure: Laparoscopic distal pancreatectomyPatients receiving laparoscopic distal pancreatectomy for pancreatic tail and body cancer |
| open distal pancreatectomy | Active comparator | Procedure: open distal pancreatectomyPatients receiving open distal pancreatectomy for pancreatic tail and body cancer |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic distal pancreatectomyLaparoscopic resection of the diseased portion of the pancreas for treatment of pancreatic cancer | Procedure or surgery | Laparoscopic distal pancreatectomy |
| open distal pancreatectomyOpen resection of the diseased portion of the pancreas for treatment of pancreatic cancer | Procedure or surgery | open distal pancreatectomy |
Primary outcome
2 year survival
Time frame: 2 years
Overall survival at 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Background: PubMed 25005018Yoon 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.
- Background: PubMed 19434700Yoon 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.
- Background: PubMed 25529901Shin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoo-Seok Yoon, M.D. Ph.D. contact
Ho-Seong Han, M.D. Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic distal pancreatectomy and open distal pancreatectomy in people with Pancreas Neoplasm Malignant Resectable, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Suh Lee, M.D. Ph.D. (+82-10-2747-6320, rudestock@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 year survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03957135, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.