Left-sided Pancreatic CancerNCT01875198
Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer
A study testing Radical Antegrade Modular Pancreatectomy with Splenectomy and Radical Antegrade Modular Pancreatectomy without splenectomy in people with Left-sided Pancreatic Cancer and Ductal Adenocarcinoma, run by Yonsei University at 1 site in South Korea.
Trial summary
When distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is usually performed not only for margin-negative resection but also for effective clearance of the splenic hilar lymph nodes. However, there was no scientific evidence regarding the justifiability for spleen resection. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Left-sided Pancreatic Cancer, Ductal Adenocarcinoma
- What is being tested?
- Radical Antegrade Modular Pancreatectomy with Splenectomy and Radical Antegrade Modular Pancreatectomy without splenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Apr 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ductal adenocarcinoma
- Age ≥20 and ≤80
- General performance status: the Karnofsky score> 70% or ECOG 0-1
- Potentially Curative resection
- Tumor size < 3cm
- Pancreatic cancer located on neck or body portion
Show all 9Show fewer
- No invasion to spleen or spleen hilum
- No combined resection except Lt. adrenal gland
- Distance more than 5cm (≥5cm) between tumor lateral margin and spleen hilum
Who cannot join
- Unresectable or locally advanced, metastatic case
- Patients who do not want surgery
- ASA (American society of anesthesiologists' physical status classification) score: ≥3
- Patients with drug or alcohol addiction
- Patients showing low compliance
- Patients who not want to involve the clinical trial
- Patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
When distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is usually performed not only for margin-negative resection but also for effective clearance of the splenic hilar lymph nodes. However, there was no scientific evidence regarding the justifiability for spleen resection. Considering potential immunological function of the spleen, the investigators hypothesized that distal pancreatectomy without pancreatectomy for left-sided pancreatic cancer is superior than Distal pancreatectomy with pancreatectomy in terms of short-term perioperative outcomes and disease-specific overall survival.
- Being tested
- Radical Antegrade Modular Pancreatectomy with Splenectomy, Radical Antegrade Modular Pancreatectomy without splenectomy
- Keywords
- Splenectomy;, Spleen-preserving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical Antegrade Modular Pancreatectomy with SplenectomyProcedure or surgery
Radical Antegrade Modular Pancreatectomy without splenectomyProcedure or surgery
distal pancreatectomy without pancreatectomy
| Study group | Role | What they receive |
|---|---|---|
| RAMPS | Experimental | Radical Antegrade Modular Pancreatectomy with Splenectomy Receives: Procedure: Radical Antegrade Modular Pancreatectomy with Splenectomy |
| RAMP | Active comparator | Radical Antegrade Modular Pancreatectomy without splenectomy Receives: Procedure: Radical Antegrade Modular Pancreatectomy without splenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding amount
Measured: 5 hours
Secondary outcomes (3)
average of pain score
Measured: admission period(about 5 days)
time interval to adjuvant treatment
Measured: admission period(about 5 days)
postoperative complication
(e.g. postoperative pancreatic fistula, delayed gastric emptying, intra-abdominal abscess, postoperative bleeding, wound infection, etc.)
Measured: admission period(about 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: because of difficulties of enrolling appropriate participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left-sided Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875198
- Sponsor's protocol ID
- 4-2013-0138
- Status last verified
- Nov 2016
- First submitted
- 28 May 2013
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim SH, Kang CM, Satoi S, Sho M, Nakamura Y, Lee WJ. Proposal for splenectomy-omitting radical distal pancreatectomy in well-selected left-sided pancreatic cancer: multicenter survey study. J Hepatobiliary Pancreat Sci. 2013 Mar;20(3):375-81. doi: 10.1007/s00534-012-0549-z.
PubMed 22911134
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01875198
- Acronym / sponsor ID
- 4-2013-0138
- Keywords
- Splenectomy;, Spleen-preserving
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: because of difficulties of enrolling appropriate participants
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Jun 2013 (estimated)
- 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 distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is usually performed not only for margin-negative resection but also for effective clearance of the splenic hilar lymph nodes. However, there was no scientific evidence regarding the justifiability for spleen resection. Considering potential immunological function of the spleen, the investigators hypothesized that distal pancreatectomy without pancreatectomy for left-sided pancreatic cancer is superior than Distal pancreatectomy with pancreatectomy in terms of short-term perioperative outcomes and disease-specific overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAMPS | Experimental | Procedure: Radical Antegrade Modular Pancreatectomy with SplenectomyRadical Antegrade Modular Pancreatectomy with Splenectomy |
| RAMP | Active comparator | Procedure: Radical Antegrade Modular Pancreatectomy without splenectomyRadical Antegrade Modular Pancreatectomy without splenectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ductal adenocarcinoma
- Age ≥20 and ≤80
- General performance status: the Karnofsky score> 70% or ECOG 0-1
- Potentially Curative resection
- Tumor size < 3cm
Key exclusion criteria (7 listed)
- Unresectable or locally advanced, metastatic case
- Patients who do not want surgery
- ASA (American society of anesthesiologists' physical status classification) score: ≥3
- Patients with drug or alcohol addiction
- Patients showing low compliance
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 |
|---|---|---|
| Radical Antegrade Modular Pancreatectomy with Splenectomy | Procedure or surgery | RAMPS |
| Radical Antegrade Modular Pancreatectomy without splenectomydistal pancreatectomy without pancreatectomy | Procedure or surgery | RAMP |
Primary outcome
Bleeding amount
Time frame: 5 hours
3 secondary outcomes
average of pain score
Time frame: admission period(about 5 days)
time interval to adjuvant treatment
Time frame: admission period(about 5 days)
postoperative complication
Time frame: admission period(about 5 days)
Results and safety
The study was stopped early (reason given: because of difficulties of enrolling appropriate participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Background: PubMed 22911134Kim SH, Kang CM, Satoi S, Sho M, Nakamura Y, Lee WJ. Proposal for splenectomy-omitting radical distal pancreatectomy in well-selected left-sided pancreatic cancer: multicenter survey study. J Hepatobiliary Pancreat Sci. 2013 Mar;20(3):375-81. doi: 10.1007/s00534-012-0549-z.
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Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical Antegrade Modular Pancreatectomy with Splenectomy and Radical Antegrade Modular Pancreatectomy without splenectomy in people with Left-sided Pancreatic Cancer and Ductal Adenocarcinoma, run by Yonsei University 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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Nov 2016. 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?
The study was stopped early (reason given: because of difficulties of enrolling appropriate participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding amount (time frame: 5 hours). 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 NCT01875198, which also lists 1 linked publication.
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 22 Nov 2016.