Pancreatic NeoplasmsPhase 3COSMOS-DPNCT02871804
Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy
A Phase 3 study testing combined resection of the splenic vein and separated resection of the splenic vein in people with Pancreatic Neoplasms, run by Wakayama Medical University at 1 site in Japan.
Trial summary
Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- combined resection of the splenic vein and separated resection of the splenic vein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2016to Feb 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective open or laparoscopic distal pancreatectomy for diseases of the pancreatic body and tail
- ECOG Performance Status (PS) = 0-1
- Age ≥ 20 years old
- Maintenance of functioning of the major organs (bone marrow, liver, kidney, lung, etc.) (a) White blood cells ≥ 2,500/mm3 (b) Haemoglobin ≥ 9.0 g/dL (c) platelets ≥ 100,000/mm3 (d) Total bilirubin ≤ 2.0 mg/dL (e) Creatinine ≤ 2.0 mg/dL (v) Sufficient judgement to understand the study and to provide written informed consent
Who cannot join
- Splenic vein-preserving distal pancreatectomy
- Superior mesenteric vein or portal vein invasion
- Pancreatic trauma
- Preoperative inflammatory pancreatic disease (pancreatitis)
- Requirement of anti-coagulant treatment during or after surgery. Anti-coagulant treatment at 24 hrs after surgery is allowed.
- Severe ischemic cardiovascular disease
Show all 14Show fewer
- Liver cirrhosis or active hepatitis
- Need for oxygen due to interstitial pneumonia or lung fibrosis
- Dialysis due to chronic renal failure
- Need for surrounding organ resection (stomach, colon, etc.), excluding the left adrenal gland and gall bladder
- Active multiple cancer that is thought to influence the occurrence of adverse events
- Difficulty with study participation due to psychotic disease or symptoms
- Inappropriate use of the stapler
- Inappropriate for the study objectives
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Wakayama Medical University
Wakayama, 641-8510
Hiroki Yamaue, MD, PhD, +81-73-441-0613, yamaue-h@wakayama-med.ac.jp
Tsutomu Fujii, MD, PhD
About this study
Official title: Comparison of Resection During Distal Pancreatectomy of the Splenic Vein Either Together With the Pancreatic Parenchyma or After Isolation: A Multicentre, Prospective, Randomized Phase III Trial
Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas).
Read the detailed description
In distal pancreatectomy, it is customary to ligate and divide the splenic vein after isolating it from the pancreatic parenchyma. This is considered essential to prevent disruption of the stump of the splenic vein and the consequent intra-abdominal haemorrhage in the event of pancreatic fistula. This procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of this trial is to confirm the non-inferiority of resection of the splenic vein embedded in the pancreatic parenchyma compared with the conventional technique of isolating the splenic vein before resection during distal pancreatectomy using a mechanical stapler.
- Conditions
- Pancreatic Neoplasms
- Being tested
- combined resection of the splenic vein, separated resection of the splenic vein
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined resection of the splenic veinProcedure or surgery
combined resection of the splenic vein with the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.
separated resection of the splenic veinProcedure or surgery
separated resection of the splenic vein from the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.
| Study group | Role | What they receive |
|---|---|---|
| separated resection of the splenic vein | Active comparator | separated resection of the splenic vein from the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers. Receives: Procedure: separated resection of the splenic vein |
| combined resection of the splenic vein | Experimental | combined resection of the splenic vein with the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers. Receives: Procedure: combined resection of the splenic vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of pancreatic fsitula grade B/C
Measured: 6 months after operation
Secondary outcomes (18)
the incidence of pancreatic fsitula of all grades
Measured: 6 months after operation
the incidence of pancreatic fsitula grade C
Measured: 6 months after operation
the incidenceof intra-abdominal haemorrhage
Measured: 6 months after operation
the incidence of all complications
Measured: 6 months after operation
comparison of the thickness of the resected pancreatic parenchyma with the incidence of PF grade B/C
Measured: 6 months after operation
mortality
Measured: 6 months after operation
the incidence of thrombosis of the splenic vein
Measured: 6 months after operation
the operative time
Measured: during operation
volume of blood loss
Measured: during operation
thickness of the resected pancreatic parenchyma
Measured: during operation
haemostasis of the staple line
Measured: during operation
integrity of the staple line
Measured: during operation
the incidence of pancreatic injury
Measured: during operation
need for additional sutures to securely close the pancreatic stump
Measured: during operation
time needed for pancreatic transection
Measured: during operation
duration of drainage tube placement
Measured: 6 months after operation
postoperative hospital stay duration
Measured: 6 months after operation
the incidence of conversion from laparoscopic surgery to open surgery
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wakayama Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroki Yamaue, Wakayama Medical University
- Investigators
- Hiroki Yamaue, MD, PhD, Principal investigator, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871804
- Sponsor's protocol ID
- COSMOS-DP trial
- Acronym
- COSMOS-DP
- Status last verified
- Aug 2016
- First submitted
- 27 Jul 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yamada S, Fujii T, Sonohara F, Kawai M, Shibuya K, Matsumoto I, Fukuzawa K, Baba H, Aoki T, Unno M, Satoi S, Kishi Y, Hatano E, Uemura K, Horiguchi A, Sho M, Takeda Y, Shimokawa T, Kodera Y, Yamaue H. Safety of Combined Division vs Separate Division of the Splenic Vein in Patients Undergoing Distal Pancreatectomy: A Noninferiority Randomized Clinical Trial. JAMA Surg. 2021 May 1;156(5):418-428. doi: 10.1001/jamasurg.2021.0108.
PubMed 33656542Yamada S, Fujii T, Kawai M, Shimokawa T, Nakamura M, Murakami Y, Satoi S, Eguchi H, Nagakawa Y, Kodera Y, Yamaue H. Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial. Trials. 2018 Jul 11;19(1):369. doi: 10.1186/s13063-018-2756-7.
PubMed 29996884
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Resection During Distal Pancreatectomy of the Splenic Vein Either Together With the Pancreatic Parenchyma or After Isolation: A Multicentre, Prospective, Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT02871804
- Acronym / sponsor ID
- COSMOS-DP / COSMOS-DP trial
- Conditions
- Pancreatic Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Wakayama Medical UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 18 Aug 2016 (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.
Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas).
Detailed description
In distal pancreatectomy, it is customary to ligate and divide the splenic vein after isolating it from the pancreatic parenchyma. This is considered essential to prevent disruption of the stump of the splenic vein and the consequent intra-abdominal haemorrhage in the event of pancreatic fistula. This procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of this trial is to confirm the non-inferiority of resection of the splenic vein embedded in the pancreatic parenchyma compared with the conventional technique of isolating the splenic vein before resection during distal pancreatectomy using a mechanical stapler.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| separated resection of the splenic vein | Active comparator | Procedure: separated resection of the splenic veinseparated resection of the splenic vein from the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers. |
| combined resection of the splenic vein | Experimental | Procedure: combined resection of the splenic veincombined resection of the splenic vein with the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective open or laparoscopic distal pancreatectomy for diseases of the pancreatic body and tail
- ECOG Performance Status (PS) = 0-1
- Age ≥ 20 years old
- Maintenance of functioning of the major organs (bone marrow, liver, kidney, lung, etc.) (a) White blood cells ≥ 2,500/mm3 (b) Haemoglobin ≥ 9.0 g/dL (c) platelets ≥ 100,000/mm3 (d) Total bilirubin ≤ 2.0 mg/dL (e) Creatinine ≤ 2.0 mg/dL (v) Sufficient judgement to understand the study and to provide written informed consent
Key exclusion criteria (14 listed)
- Splenic vein-preserving distal pancreatectomy
- Superior mesenteric vein or portal vein invasion
- Pancreatic trauma
- Preoperative inflammatory pancreatic disease (pancreatitis)
- Requirement of anti-coagulant treatment during or after surgery. Anti-coagulant treatment at 24 hrs after surgery is allowed.
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 |
|---|---|---|
| combined resection of the splenic veincombined resection of the splenic vein with the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers. | Procedure or surgery | combined resection of the splenic vein |
| separated resection of the splenic veinseparated resection of the splenic vein from the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers. | Procedure or surgery | separated resection of the splenic vein |
Primary outcome
the incidence of pancreatic fsitula grade B/C
Time frame: 6 months after operation
18 secondary outcomes
the incidence of pancreatic fsitula of all grades
Time frame: 6 months after operation
the incidence of pancreatic fsitula grade C
Time frame: 6 months after operation
the incidenceof intra-abdominal haemorrhage
Time frame: 6 months after operation
the incidence of all complications
Time frame: 6 months after operation
comparison of the thickness of the resected pancreatic parenchyma with the incidence of PF grade B/C
Time frame: 6 months after operation
mortality
Time frame: 6 months after operation
the incidence of thrombosis of the splenic vein
Time frame: 6 months after operation
the operative time
Time frame: during operation
volume of blood loss
Time frame: during operation
thickness of the resected pancreatic parenchyma
Time frame: during operation
haemostasis of the staple line
Time frame: during operation
integrity of the staple line
Time frame: during operation
the incidence of pancreatic injury
Time frame: during operation
need for additional sutures to securely close the pancreatic stump
Time frame: during operation
time needed for pancreatic transection
Time frame: during operation
duration of drainage tube placement
Time frame: 6 months after operation
postoperative hospital stay duration
Time frame: 6 months after operation
the incidence of conversion from laparoscopic surgery to open surgery
Time frame: during operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Derived from this study: PubMed 33656542Yamada S, Fujii T, Sonohara F, Kawai M, Shibuya K, Matsumoto I, Fukuzawa K, Baba H, Aoki T, Unno M, Satoi S, Kishi Y, Hatano E, Uemura K, Horiguchi A, Sho M, Takeda Y, Shimokawa T, Kodera Y, Yamaue H. Safety of Combined Division vs Separate Division of the Splenic Vein in Patients Undergoing Distal Pancreatectomy: A Noninferiority Randomized Clinical Trial. JAMA Surg. 2021 May 1;156(5):418-428. doi: 10.1001/jamasurg.2021.0108.
- Derived from this study: PubMed 29996884Yamada S, Fujii T, Kawai M, Shimokawa T, Nakamura M, Murakami Y, Satoi S, Eguchi H, Nagakawa Y, Kodera Y, Yamaue H. Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial. Trials. 2018 Jul 11;19(1):369. doi: 10.1186/s13063-018-2756-7.
- 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.
Hiroki Yamaue, MD, PhD principal investigator
Wakayama Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing combined resection of the splenic vein and separated resection of the splenic vein in people with Pancreatic Neoplasms, run by Wakayama Medical University at 1 site in Japan.
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 4 inclusion and 14 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 18 Aug 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 Japan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hiroki Yamaue, MD, PhD (+81-73-441-0613, yamaue-h@wakayama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of pancreatic fsitula grade B/C (time frame: 6 months after operation). 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 NCT02871804, which also lists 2 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 18 Aug 2016.