Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer
NCT ID: NCT03792932
Last Updated: 2022-06-22
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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UNKNOWN
NA
306 participants
INTERVENTIONAL
2019-02-02
2023-01-31
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
NONE
Study Groups
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Laparoscopic distal pancreatectomy
Laparoscopic distal pancreatectomy
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).
Open distal pancreatectomy
Open distal pancreatectomy
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).
Interventions
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Laparoscopic distal pancreatectomy
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).
Open distal pancreatectomy
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).
Eligibility Criteria
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Inclusion Criteria
2. Resectable body and tail pancreatic cancer (refer to NCCN 2018)
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
4. Tumor locates at the body and tail of the pancreas without distant metastasis
5. No celiac trunk and superior mesenteric artery invasion
6. No operation contraindication, fit for laparoscopic surgery
7. The expected survival after surgery ≥ 3 months
8. Patients who are willing and able to comply with the study procedure
9. Signed informed content obtained prior to treatment
Exclusion Criteria
2. Multi-organ and vascular resection needed
3. Patients undergoing total pancreatectomy
4. Benign tumor at the body and tail of the pancreas or pancreatic cancer at the head of the pancreas
5. Distant metastasis or ascites detected by imaging
6. Severe important organ function impairment (heart, liver, kidney)
7. Patients who are with other primary malignancy or haematological disorders
8. Pregnant or nursing women
9. Patients who have received chemotherapy, radiotherapy and interventional therapy before the pancreatectomy
10. Patients who have participated in other clinical trials for pancreatic cancer treatment within 3 months
19 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xian-Jun Yu
Chair of Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Locations
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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
Department of Hepatobiliary and Pancreatic Surgery, The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Department of Hepatopancreatobiliary Surgery, Second Affiliated Hospital of Harbin Medical University,
Harbin, Heilongjiang, China
Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Department of Hepato-Pancreato-Biliary Surgery, The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, China
Shanghai, Shanghai Municipality, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
West China Hospital
Chengdu, Sichuan, China
Department of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People's Hospital
Hanzhou, Zhejiang, China
Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University
Harbin, , China
Department of Biliopancreatic Surgery, Huadong Hospital, Fudan University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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chenlin zhu
Role: primary
Jianhua Liu
Role: primary
Wenxing Zhao
Role: primary
Weiwei Jin
Role: primary
Hua Chen
Role: primary
References
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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.
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.
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.
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.
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.
Liu C, Cheng H, Wang M, Cai Y, Jiang C, Tang L, Luo G, Jin K, Ji S, Xu W, Shi S, Wang X, Liu M, Zhao W, Xu X, Xu J, Wu W, Wang W, Liu J, Shao C, Peng B, Qin R, Yu X; Chinese Study Group for Pancreatic Cancer (CSPAC). Effect of Laparoscopic versus Open Distal Pancreatectomy on Recurrence-Free Survival in Patients with Left-sided Pancreatic Cancer: A randomized controlled trial. Ann Surg. 2025 Feb 25. doi: 10.1097/SLA.0000000000006681. Online ahead of print.
Other Identifiers
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CSPAC-2
Identifier Type: -
Identifier Source: org_study_id
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