Clinical trial NCT03792932: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Surgery
Laparoscopy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 306
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence Free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: R0 resection rate
timeFrame: 2 years
measure: Detected lymph node number
timeFrame: 2 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
state: Anhui
city: Shijiazhuang
country: China
facility: Department of Hepatobiliary and Pancreatic Surgery, The Second Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Department of Hepatopancreatobiliary Surgery, Second Affiliated Hospital of Harbin Medical University,
state: Heilongjiang
city: Wuhan
country: China
facility: Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Xuzhou
country: China
facility: Department of Hepato-Pancreato-Biliary Surgery, The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Shanghai
country: China
facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, China
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Hanzhou
country: China
facility: Department of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People's Hospital
state: Zhejiang
city: Harbin
country: China
facility: Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University
city: Shanghai
country: China
facility: Department of Biliopancreatic Surgery, Huadong Hospital, Fudan University
Study officials:
References:
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