RAMPS VS SRPS for Pancreatic Body and Tail Adenocarcinoma
NCT ID: NCT04253847
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
224 participants
INTERVENTIONAL
2020-02-15
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RAMPS group
Radical antegrade modular pancreatosplenectomy (RAMPS) includes the following aspects. Firstly, the surgical approach is "antegrade", which means from the right to the left, the pancreatic neck will be transected at first and the spleen will be seperated at last. Secondly, lymph nodes dissection includes not only the regional lymph nodes(No.10,11,18 lymph nodes), but also N1 station lymph nodes (N1: 6, 8a, 8p, 12a2/b2/p2, 13a/b, 14b/c/d, 14v, 17a/b), No.7, 9 lymph nodes, the lymph nodes anterior and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called "posterior approach RAMPS". While in normal cases, left adrenal gland will be preserved.
Radical antegrade modular pancreatosplenectomy
Radical antegrade modular pancreatosplenectomy (RAMPS) includes the following aspects. Firstly, the surgical approach is "antegrade", which means from the right to the left, the pancreatic neck will be transected at first and the spleen will be seperated at last. Secondly, lymph nodes dissection includes not only the regional lymph nodes(No.10,11,18 lymph nodes), but also N1 station lymph nodes (N1: 6, 8a, 8p, 12a2/b2/p2, 13a/b, 14b/c/d, 14v, 17a/b), No.7, 9 lymph nodes, the lymph nodes anterior and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called "posterior approach RAMPS". While in normal cases, left adrenal gland will be preserved.
SRPS group
Standard retrograde pancreatosplenectomy(SRPS) includes several key points. Firstly, the surgical approach is "retrograde", which means from the left to the right, spleen will be seperated at first and the pancreas will be transected later on. Secondly, only the regional lymph nodes will be dissected, which include No.10, No.11, No.18 lymph nodes, and No.9 lymph nodes should be dissected only when the lesion is in pancreatic neck. Thirdly, the transection platform is in the left side of the lesion, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved.
Standard retrograde pancreatosplenectomy
Standard retrograde pancreatosplenectomy(SRPS) includes several aspects. Firstly, the surgical approach is "retrograde", which means from the left to the right, spleen will be seperated at first and the pancreas will be transected later on. Secondly, only the regional lymph nodes will be dissected, which include No.10, No.11, No.18 lymph nodes, and No.9 lymph nodes should be dissected only when the lesion is in pancreatic neck. Thirdly, the transection platform is in the left side of the lesion, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved.
Interventions
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Radical antegrade modular pancreatosplenectomy
Radical antegrade modular pancreatosplenectomy (RAMPS) includes the following aspects. Firstly, the surgical approach is "antegrade", which means from the right to the left, the pancreatic neck will be transected at first and the spleen will be seperated at last. Secondly, lymph nodes dissection includes not only the regional lymph nodes(No.10,11,18 lymph nodes), but also N1 station lymph nodes (N1: 6, 8a, 8p, 12a2/b2/p2, 13a/b, 14b/c/d, 14v, 17a/b), No.7, 9 lymph nodes, the lymph nodes anterior and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called "posterior approach RAMPS". While in normal cases, left adrenal gland will be preserved.
Standard retrograde pancreatosplenectomy
Standard retrograde pancreatosplenectomy(SRPS) includes several aspects. Firstly, the surgical approach is "retrograde", which means from the left to the right, spleen will be seperated at first and the pancreas will be transected later on. Secondly, only the regional lymph nodes will be dissected, which include No.10, No.11, No.18 lymph nodes, and No.9 lymph nodes should be dissected only when the lesion is in pancreatic neck. Thirdly, the transection platform is in the left side of the lesion, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved.
Eligibility Criteria
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Inclusion Criteria
* Resectable pancreatic body and tail ductal adenocarcinoma with both preoperative and intraoperative evaluation(refer to NCCN guideline 2018 of Pancreatic Cancer);
* ECOG Performance Status 0-1;
* Adenocarcinoma of pancreatic body and tail duct, without distant metastasis and ascites;
* The estimated survival time is ≥ 3 months;
* Follow-up in time and obey the research requirements;
* Be voluntary to this clinical trial and can sign the informed consent;
* Normal hematological index (Leukocyte, platelet, liver function, renal function, DIC, electrolyte index, Hb \>10g/dL).
Exclusion Criteria
* Patients with recurrent pancreatic ductal adenocarcinoma;
* The artery or vein is involved and could not be resected or reconstructed(according to preoperative evaluation or intraoperative evaluation after exploration);
* Patients with cardiopulmonary disfunction and cannot tolerate operation;
* The patients accepted neoadjuvant chemotherapy and radiotherapy before operation;
* Patients with other malignancies or hematopathy
* Before the operation, the total bilirubin was more than 250 μmol/L without preoperative biliary drainage or after biliary drainage, the total bilirubin was still more than 250 μmol/L;
* Pregnancy diagnosed, planned pregnancy and lactating female patients
* Refusal to sign consent.
* Intraoperative exclusion include:Tumor metastasis; not pancreatic primary disease; unresectable pancreatic body/tail adenocarcinoma
* Postoperative exclusion include: not pancreatic ductal adenocarcinoma according to pathological examination.
* Withdrawal of informed consent;
* Willingness to withdraw from the study.
18 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Yuanchi Weng
Attending Physician
Locations
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Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HBP-RCT-005
Identifier Type: -
Identifier Source: org_study_id
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