Resectable Pancreatic Body/Tail CarcinomaISOP-DPNCT04600063
Isolation Procedure vs. Conventional Procedure During Distal Pancreatectosplenectomy for Pancreatic Cancer
A study testing Isolation procedure (RAMPS procedure) and Conventional procedure in people with Resectable Pancreatic Body/Tail Carcinoma, run by Wakayama Medical University at 10 sites in Japan.
Trial summary
In the distal pancreatectomy (including pancreatic tail resection) for invasive ductal carcinoma of the pancreas, we evaluate the usefulness of a procedure of firstly transection of splenic arteries and veins (the isolation procedure group) compared to a conventional procedure of transection of the splenic vein at the… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Resectable Pancreatic Body/Tail Carcinoma
- What is being tested?
- Isolation procedure (RAMPS procedure) and Conventional procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesJapan
- Study dates
- 1 Oct 2020to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resectable pancreatic cancer (Adenocarcinoma, adenosquamous cell carcinoma, mucinous carcinoma, and anaplastic carcinoma according to the 7th edition of the regulations for handling pancreatic cancer)
- ASA-PS (American Society of Anesthesiology, General condition classification) is Class 1-3.
- Age are over 20 years old.
- Able to understand the content of the research and has obtained written consent from the person himself/herself.
Who cannot join
- Non-resectable pancreatic cancer by image diagnosis at the initial diagnosis
- Cases suspected of portal vein (superior mesenteric vein) invasion
- Patients with severe ischemic heart disease
- Patients with cirrhosis or active hepatitis requiring treatment
- Patients with dyspnea requiring oxygen administration
- Patients undergoing dialysis due to chronic renal failure
Show all 14Show fewer
- Cases in which arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. is considered necessary
- Patients with strong suspected paraaortic lymph node metastasis
- Active double cancer thought to affect adverse events and prognosis
- Long-term oral steroids that may affect adverse events
- Patients who are considered to have difficulty participating in the study due to psychosis or psychiatric symptoms.
- Cases other than invasive pancreatic ductal carcinoma by preoperative biopsy. Invasive intraductal papillary mucinous carcinoma (IPMC) is excluded.
- Patients who cannot use both iodine drugs and gadnium drugs due to severe drug allergy
- Cases where the prescribed procedure is difficult due to history of upper abdominal surgery such as stomach, spleen, kidney, liver, transverse colon, retroperitoneum including pancreas and pancreatitis
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites, 10 recruiting
- Not yet recruiting
Nara Medical University
Kashihara, Nara
Masayuki Sho, M.D., PhD.
- Not yet recruiting
Kobe University
Kobe, Hyōgo
Hirochika Toyama, M.D., PhD.
Hirochika Toyama, M.D., PhD.
- Not yet recruiting
Kumamoto University
Kumamoto
Hideo Baba
- Not yet recruiting
Osaka City University
Osaka
Ryosuke Amano, M.D., PhD.
Ryosuke Amano, M.D., PhD.
- Not yet recruiting
Shiga Medical University
Ōtsu, Shiga
Masaji Tani, M.D., Ph.D.
- Not yet recruiting
Kinki University
Sayama, Osaka
Ippei Matsumoto, M.D., PhD
- Not yet recruiting
Osaka University
Suita, Osaka
Hidetoshi Eguchi, M.D., Ph.D.
- Not yet recruiting
Jikei University
Tokyo
Takeshi Gocho, MD, PhD, +81-3-3433-1111, gocho@jikei.ac.jp
- Not yet recruiting
Toyama University
Toyama
Tsutomu Fujii
- Recruiting
Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera
Wakayama, 641-8510
Ken-ichi Okada, MD, +81-73-441-0613, okada@wakayama-med.ac.jp
Ken-ichi Okada, MD, PhD
About this study
Official title: Randomized Controlled Phase II Study of Isolation Procedure Versus Conventional Procedure in Distal Pancreatosplenectomy for Pancreatic Cancer
In the distal pancreatectomy (including pancreatic tail resection) for invasive ductal carcinoma of the pancreas, we evaluate the usefulness of a procedure of firstly transection of splenic arteries and veins (the isolation procedure group) compared to a conventional procedure of transection of the splenic vein at the end.
- Being tested
- Isolation procedure (RAMPS procedure), Conventional procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolation procedure (RAMPS procedure)Procedure or surgery
In the Isolation procedure group, the transection of the root of the splenic artery and the pancreatic transection are performed first, followed by the transection of the splenic vein (mandatory procedure). At that time, the branch from the splenic artery (dorsal pancreatic artery), the branch to the splenic vein (left gastric vein, inferior mesenteric vein), and short gastric arteriovenous are also disconnected as soon as possible (recommended procedure). An operation to lift up the pancreatic neck from the dorsal portal vein or superior mesenteric artery to expose the splenic vein (so-called tunneling) is allowed. After that, lymph node dissection such as hepatoduodenal mesentery (No12), common hepatic artery perimeter (No8), lymph node dissection around SMA (No14p) was performed (recommended procedure), and at the end of the resection operation, the pancreas body/tail and spleen are mobilized and removed (required procedure).
Conventional procedureProcedure or surgery
In the conventional procedure group, first, the pancreatic body and tail and spleen are mobilized (mandatory procedure), and the regional lymph nodes of the body and tail of the pancreas, such as the hepatoduodenal mesentery (No12 lymph node) and the common hepatic artery perimeter (No8), are removed. (Recommended procedure) and dissection of lymph nodes (No14p) around SMA (Recommended procedure), and after dissection of the gastro-splenic ligament and pancreas, transection of the splenic vein at the end of the resection procedure (required procedure) . However, in order to prevent bleeding and secure a safe field of view, early pancreatotomy is allowed.
| Study group | Role | What they receive |
|---|---|---|
| Conventional procedure | Other | In the conventional procedure group, first, the pancreatic body and tail and spleen are mobilized (mandatory procedure), and the regional lymph nodes of the body and tail of the pancreas, such as the hepatoduodenal mesentery (No12 lymph node) and the common hepatic artery perimeter (No8), are removed. (Recommended procedure) and dissection of lymph nodes (No14p) around SMA (Recommended procedure), and after dissection of the gastro-splenic ligament and pancreas, transection of the splenic vein at the end of the resection procedure (required procedure) . However, in order to prevent bleeding and secure a safe field of view, early pancreatotomy is allowed. Receives: Procedure: Isolation procedure (RAMPS procedure); Procedure: Conventional procedure |
| Isolation procedure (RAMPS procedure) | Experimental | In the Isolation procedure group, the transection of the root of the splenic artery and the pancreatic transection are performed first, followed by the transection of the splenic vein (mandatory procedure). At that time, the branch from the splenic artery (dorsal pancreatic artery), the branch to the splenic vein (left gastric vein, inferior mesenteric vein), and short gastric arteriovenous are also disconnected as soon as possible (recommended procedure). An operation to lift up the pancreatic neck from the dorsal portal vein or superior mesenteric artery to expose the splenic vein (so-called tunneling) is allowed. After that, lymph node dissection such as hepatoduodenal mesentery (No12), common hepatic artery perimeter (No8), lymph node dissection around SMA (No14p) was performed (recommended procedure), and at the end of the resection operation, the pancreas body/tail and spleen are mobilized and removed (required procedure). Receives: Procedure: Isolation procedure (RAMPS procedure); Procedure: Conventional procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence-free survival
Until 2 years after last entry case undergo surgery
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
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 Resectable Pancreatic Body/Tail CarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600063
- Sponsor's protocol ID
- 2986
- Acronym
- ISOP-DP
- Status last verified
- Oct 2020
- First submitted
- 18 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okada KI, Kawai M, Hirono S, Sho M, Tani M, Matsumoto I, Yamada S, Amano R, Toyama H, Yamashita YI, Gocho T, Shibuya K, Nagai M, Maehira H, Kamei K, Ohira G, Shirai Y, Takami H, Kimura N, Fukumoto T, Baba H, Kodera Y, Nakao A, Shimokawa T, Katsuda M, Yamaue H. ISOlation Procedure vs. conventional procedure during Distal Pancreatectomy (ISOP-DP trial): study protocol for a randomized controlled trial. Trials. 2021 Sep 16;22(1):633. doi: 10.1186/s13063-021-05523-y.
PubMed 34530885
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Phase II Study of Isolation Procedure Versus Conventional Procedure in Distal Pancreatosplenectomy for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04600063
- Acronym / sponsor ID
- ISOP-DP / 2986
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wakayama Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 23 Oct 2020 (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.
In the distal pancreatectomy (including pancreatic tail resection) for invasive ductal carcinoma of the pancreas, we evaluate the usefulness of a procedure of firstly transection of splenic arteries and veins (the isolation procedure group) compared to a conventional procedure of transection of the splenic vein at the end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional procedure | Other | Procedure: Isolation procedure (RAMPS procedure), Procedure: Conventional procedureIn the conventional procedure group, first, the pancreatic body and tail and spleen are mobilized (mandatory procedure), and the regional lymph nodes of the body and tail of the pancreas, such as the hepatoduodenal mesentery (No12 lymph node) and the common hepatic artery perimeter (No8), are removed. (Recommended procedure) and dissection of lymph nodes (No14p) around SMA (Recommended procedure), and after dissection of the gastro-splenic ligament and pancreas, transection of the splenic vein at the end of the resection procedure (required procedure) . However, in order to prevent bleeding and secure a safe field of view, early pancreatotomy is allowed. |
| Isolation procedure (RAMPS procedure) | Experimental | Procedure: Isolation procedure (RAMPS procedure), Procedure: Conventional procedureIn the Isolation procedure group, the transection of the root of the splenic artery and the pancreatic transection are performed first, followed by the transection of the splenic vein (mandatory procedure). At that time, the branch from the splenic artery (dorsal pancreatic artery), the branch to the splenic vein (left gastric vein, inferior mesenteric vein), and short gastric arteriovenous are also disconnected as soon as possible (recommended procedure). An operation to lift up the pancreatic neck from the dorsal portal vein or superior mesenteric artery to expose the splenic vein (so-called tunneling) is allowed. After that, lymph node dissection such as hepatoduodenal mesentery (No12), common hepatic artery perimeter (No8), lymph node dissection around SMA (No14p) was performed (recommended procedure), and at the end of the resection operation, the pancreas body/tail and spleen are mobilized and removed (required procedure). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Resectable pancreatic cancer (Adenocarcinoma, adenosquamous cell carcinoma, mucinous carcinoma, and anaplastic carcinoma according to the 7th edition of the regulations for handling pancreatic cancer)
- ASA-PS (American Society of Anesthesiology, General condition classification) is Class 1-3.
- Age are over 20 years old.
- Able to understand the content of the research and has obtained written consent from the person himself/herself.
Key exclusion criteria (14 listed)
- Non-resectable pancreatic cancer by image diagnosis at the initial diagnosis
- Cases suspected of portal vein (superior mesenteric vein) invasion
- Patients with severe ischemic heart disease
- Patients with cirrhosis or active hepatitis requiring treatment
- Patients with dyspnea requiring oxygen administration
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 |
|---|---|---|
| Isolation procedure (RAMPS procedure)In the Isolation procedure group, the transection of the root of the splenic artery and the pancreatic transection are performed first, followed by the transection of the splenic vein (mandatory procedure). At that time, the branch from the splenic artery (dorsal pancreatic artery), the branch to the splenic vein (left gastric vein, inferior mesenteric vein), and short gastric arteriovenous are also disconnected as soon as possible (recommended procedure). An operation to lift up the pancreatic neck from the dorsal portal vein or superior mesenteric artery to expose the splenic vein (so-called tunneling) is allowed. After that, lymph node dissection such as hepatoduodenal mesentery (No12), common hepatic artery perimeter (No8), lymph node dissection around SMA (No14p) was performed (recommended procedure), and at the end of the resection operation, the pancreas body/tail and spleen are mobilized and removed (required procedure). | Procedure or surgery | Conventional procedure, Isolation procedure (RAMPS procedure) |
| Conventional procedureIn the conventional procedure group, first, the pancreatic body and tail and spleen are mobilized (mandatory procedure), and the regional lymph nodes of the body and tail of the pancreas, such as the hepatoduodenal mesentery (No12 lymph node) and the common hepatic artery perimeter (No8), are removed. (Recommended procedure) and dissection of lymph nodes (No14p) around SMA (Recommended procedure), and after dissection of the gastro-splenic ligament and pancreas, transection of the splenic vein at the end of the resection procedure (required procedure) . However, in order to prevent bleeding and secure a safe field of view, early pancreatotomy is allowed. | Procedure or surgery | Conventional procedure, Isolation procedure (RAMPS procedure) |
Primary outcome
2-year recurrence-free survival
Time frame: Up to 24 months
Until 2 years after last entry case undergo surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Derived from this study: PubMed 34530885Okada KI, Kawai M, Hirono S, Sho M, Tani M, Matsumoto I, Yamada S, Amano R, Toyama H, Yamashita YI, Gocho T, Shibuya K, Nagai M, Maehira H, Kamei K, Ohira G, Shirai Y, Takami H, Kimura N, Fukumoto T, Baba H, Kodera Y, Nakao A, Shimokawa T, Katsuda M, Yamaue H. ISOlation Procedure vs. conventional procedure during Distal Pancreatectomy (ISOP-DP trial): study protocol for a randomized controlled trial. Trials. 2021 Sep 16;22(1):633. doi: 10.1186/s13063-021-05523-y.
- Individual participant dataSharing planned: No
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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolation procedure (RAMPS procedure) and Conventional procedure in people with Resectable Pancreatic Body/Tail Carcinoma, run by Wakayama Medical University at 10 sites 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 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
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 Ken-ichi Okada (+81734410613 ext. 5112, okada@wakayama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence-free survival (time frame: Up to 24 months). 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 NCT04600063, 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 23 Oct 2020.