Back to resultsLaparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer
Primary Purpose
Pancreatic Cancer, Surgery, Laparoscopy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic distal pancreatectomy
Open distal pancreatectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 19 years and ≤ 80 years, no gender limitation
- Resectable body and tail pancreatic cancer (refer to NCCN 2018)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Tumor locates at the body and tail of the pancreas without distant metastasis
- No celiac trunk and superior mesenteric artery invasion
- No operation contraindication, fit for laparoscopic surgery
- The expected survival after surgery ≥ 3 months
- Patients who are willing and able to comply with the study procedure
- Signed informed content obtained prior to treatment
Exclusion Criteria:
- Locally advanced unresectable body and tail pancreatic cancer
- Multi-organ and vascular resection needed
- Patients undergoing total pancreatectomy
- Benign tumor at the body and tail of the pancreas or pancreatic cancer at the head of the pancreas
- Distant metastasis or ascites detected by imaging
- Severe important organ function impairment (heart, liver, kidney)
- Patients who are with other primary malignancy or haematological disorders
- Pregnant or nursing women
- Patients who have received chemotherapy, radiotherapy and interventional therapy before the pancreatectomy
- Patients who have participated in other clinical trials for pancreatic cancer treatment within 3 months
Sites / Locations
- The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)Recruiting
- Department of Hepatobiliary and Pancreatic Surgery, The Second Hospital of Hebei Medical UniversityRecruiting
- Department of Hepatopancreatobiliary Surgery, Second Affiliated Hospital of Harbin Medical University,Recruiting
- Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
- Department of Hepato-Pancreato-Biliary Surgery, The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
- Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, ChinaRecruiting
- Shanghai Changzheng HospitalRecruiting
- West China HospitalRecruiting
- Department of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People's HospitalRecruiting
- Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical UniversityRecruiting
- Department of Biliopancreatic Surgery, Huadong Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Laparoscopic distal pancreatectomy
Open distal pancreatectomy
Arm Description
Outcomes
Primary Outcome Measures
Recurrence Free Survival
RFS
Secondary Outcome Measures
Overall Survival
OS
R0 resection rate
R0 resection rate
Detected lymph node number
Detected lymph node number
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03792932
Brief Title
Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer
Official Title
A Multicenter Prospective RCT Study of Laparoscopic Versus Open Distal Pancreatectomy in Patients With Pancreatic Cancer at the Body and Tail
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Open distal pancreatectomy (ODP) has been commonly employed for the treatment of a variety of cancers in body and tail of pancreas. Although many general surgical procedures have been increasingly performed laparoscopically or with laparoscopic assistance, until the current decade, laparoscopic pancreatic surgery had not been performed for its complicated anatomy. But laparoscopic distal pancreatectomy (LDP) has been widely accepted as a standard treatment for body and tail pancreatic cancer because there is no anastomosis in it, and LDP has gradually become the first choice for these cancers in clinical work. Although there are several studies about the comparison between LDP and ODP, most are retrospective and there is no agreement in surgical margin, lymph node numbers and prognosis to identify the oncological differences between the two surgical approaches. The investigators' pilot study showed that patients with body and tail pancreatic cancer underwent LDP had a better prognosis compared with the ones undergoing ODP, with no statistics differences in postoperative complications and mortality. This perspective RCT study is performed to confirm whether LDP would improve the prognosis for patients with body and tail pancreatic cancer compared with ODP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Surgery, Laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic distal pancreatectomy
Arm Type
Active Comparator
Arm Title
Open distal pancreatectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic distal pancreatectomy
Intervention Description
Laparoscopic distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
Intervention Type
Procedure
Intervention Name(s)
Open distal pancreatectomy
Intervention Description
Open distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
Primary Outcome Measure Information:
Title
Recurrence Free Survival
Description
RFS
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
OS
Time Frame
2 years
Title
R0 resection rate
Description
R0 resection rate
Time Frame
2 years
Title
Detected lymph node number
Description
Detected lymph node number
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 19 years and ≤ 80 years, no gender limitation
Resectable body and tail pancreatic cancer (refer to NCCN 2018)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Tumor locates at the body and tail of the pancreas without distant metastasis
No celiac trunk and superior mesenteric artery invasion
No operation contraindication, fit for laparoscopic surgery
The expected survival after surgery ≥ 3 months
Patients who are willing and able to comply with the study procedure
Signed informed content obtained prior to treatment
Exclusion Criteria:
Locally advanced unresectable body and tail pancreatic cancer
Multi-organ and vascular resection needed
Patients undergoing total pancreatectomy
Benign tumor at the body and tail of the pancreas or pancreatic cancer at the head of the pancreas
Distant metastasis or ascites detected by imaging
Severe important organ function impairment (heart, liver, kidney)
Patients who are with other primary malignancy or haematological disorders
Pregnant or nursing women
Patients who have received chemotherapy, radiotherapy and interventional therapy before the pancreatectomy
Patients who have participated in other clinical trials for pancreatic cancer treatment within 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xianjun Yu, M.D., Ph.D.
Phone
+86-21-64175590
Ext
1307
Email
yuxianjun@fudanpci.org
First Name & Middle Initial & Last Name or Official Title & Degree
He Cheng, M.D., Ph.D.
Phone
+86-21-64175590
Ext
1307
Email
chenghe@fudanpci.org
Facility Information:
Facility Name
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chenlin zhu
Facility Name
Department of Hepatobiliary and Pancreatic Surgery, The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Liu
Facility Name
Department of Hepatopancreatobiliary Surgery, Second Affiliated Hospital of Harbin Medical University,
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhidong Wang
Email
wangzhidong@hrbmu.edu.cn
Facility Name
Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renyi Qin, PHD
Email
ryqin@tjh.tjmu.edu.cn
Facility Name
Department of Hepato-Pancreato-Biliary Surgery, The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenxing Zhao
Facility Name
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianjun Yu, M.D., Ph.D.
Phone
+86-21-6417-5590
Ext
1307
Email
yuxianjun@fudanpci.org
First Name & Middle Initial & Last Name & Degree
He Cheng, M.D., Ph.D.
Phone
+86-21-6417-5590
Ext
1307
Email
chenghe@fudanpci.org
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Tang, Dr.
Phone
13918874380
Email
tlehbh@126.com
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunqiang Cai, Dr.
Phone
17721950223
Email
494374409@qq.com
Facility Name
Department of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People's Hospital
City
Hanzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiwei Jin
Facility Name
Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University
City
Harbin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Chen
Facility Name
Department of Biliopancreatic Surgery, Huadong Hospital, Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang
Email
wangw2003cn@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25560180
Citation
Ricci C, Casadei R, Taffurelli G, Toscano F, Pacilio CA, Bogoni S, D'Ambra M, Pagano N, Di Marco MC, Minni F. Laparoscopic versus open distal pancreatectomy for ductal adenocarcinoma: a systematic review and meta-analysis. J Gastrointest Surg. 2015 Apr;19(4):770-81. doi: 10.1007/s11605-014-2721-z. Epub 2015 Jan 6.
Results Reference
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PubMed Identifier
29099399
Citation
van Hilst J, de Rooij T, Klompmaker S, Rawashdeh M, Aleotti F, Al-Sarireh B, Alseidi A, Ateeb Z, Balzano G, Berrevoet F, Bjornsson B, Boggi U, Busch OR, Butturini G, Casadei R, Del Chiaro M, Chikhladze S, Cipriani F, van Dam R, Damoli I, van Dieren S, Dokmak S, Edwin B, van Eijck C, Fabre JM, Falconi M, Farges O, Fernandez-Cruz L, Forgione A, Frigerio I, Fuks D, Gavazzi F, Gayet B, Giardino A, Groot Koerkamp B, Hackert T, Hassenpflug M, Kabir I, Keck T, Khatkov I, Kusar M, Lombardo C, Marchegiani G, Marshall R, Menon KV, Montorsi M, Orville M, de Pastena M, Pietrabissa A, Poves I, Primrose J, Pugliese R, Ricci C, Roberts K, Rosok B, Sahakyan MA, Sanchez-Cabus S, Sandstrom P, Scovel L, Solaini L, Soonawalla Z, Souche FR, Sutcliffe RP, Tiberio GA, Tomazic A, Troisi R, Wellner U, White S, Wittel UA, Zerbi A, Bassi C, Besselink MG, Abu Hilal M; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Minimally Invasive versus Open Distal Pancreatectomy for Ductal Adenocarcinoma (DIPLOMA): A Pan-European Propensity Score Matched Study. Ann Surg. 2019 Jan;269(1):10-17. doi: 10.1097/SLA.0000000000002561.
Results Reference
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PubMed Identifier
26583678
Citation
Sulpice L, Farges O, Goutte N, Bendersky N, Dokmak S, Sauvanet A, Delpero JR; ACHBT French Pancreatectomy Study Group. Laparoscopic Distal Pancreatectomy for Pancreatic Ductal Adenocarcinoma: Time for a Randomized Controlled Trial? Results of an All-inclusive National Observational Study. Ann Surg. 2015 Nov;262(5):868-73; discussion 873-4. doi: 10.1097/SLA.0000000000001479.
Results Reference
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PubMed Identifier
25529901
Citation
Shin 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.
Results Reference
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PubMed Identifier
22511003
Citation
Venkat R, Edil BH, Schulick RD, Lidor AO, Makary MA, Wolfgang CL. Laparoscopic distal pancreatectomy is associated with significantly less overall morbidity compared to the open technique: a systematic review and meta-analysis. Ann Surg. 2012 Jun;255(6):1048-59. doi: 10.1097/SLA.0b013e318251ee09.
Results Reference
background
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Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer
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