Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Multicenter Prospective RCT Study of Laparoscopic Versus Open Distal Pancreatectomy in Patients With Pancreatic Cancer at the Body and Tail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792932
• Other study ID #: CSPAC-2
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: June 2022
• Source: Fudan University
• Contact: Xianjun Yu, M.D., Ph.D.
• Phone: +86-21-64175590
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age = 19 years and = 80 years, no gender limitation

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:

1. Locally advanced unresectable body and tail pancreatic cancer

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

Related Conditions & MeSH terms

• Laparoscopy
• Pancreatic Cancer
• Pancreatic Neoplasms
• Surgery

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan
China	Department of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People's Hospital	Hanzhou	Zhejiang
China	Department of Hepatopancreatobiliary Surgery, Second Affiliated Hospital of Harbin Medical University,	Harbin	Heilongjiang
China	Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University	Harbin
China	The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)	Hefei	Anhui
China	Department of Biliopancreatic Surgery, Huadong Hospital, Fudan University	Shanghai
China	Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, China	Shanghai	Shanghai
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	Department of Hepatobiliary and Pancreatic Surgery, The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
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

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View 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. — View 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. — View Citation

van Hilst J, de Rooij T, Klompmaker S, Rawashdeh M, Aleotti F, Al-Sarireh B, Alseidi A, Ateeb Z, Balzano G, Berrevoet F, Björnsson 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, Fernández-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, Røsok B, Sahakyan MA, Sánchez-Cabús S, Sandström 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Free Survival	RFS	2 years
Secondary	Overall Survival	OS	2 years
Secondary	R0 resection rate	R0 resection rate	2 years
Secondary	Detected lymph node number	Detected lymph node number	2 years