Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer

Not Applicable

• Conditions: Pancreatic Cancer; Laparoscopy; Surgery
• Interventions: Procedure: Laparoscopic distal pancreatectomy; Procedure: Open distal pancreatectomy

• Registration Number: NCT03792932
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-12-27
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-04
• Study Start: 2019-02-02
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-19
• Last Update Posted: 2022-06-22
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 306

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic distal pancreatectomy	Laparoscopic distal pancreatectomy	-
Open distal pancreatectomy	Open distal pancreatectomy	-

Primary Outcome Measures

Name	Time	Method
Recurrence Free Survival	2 years	RFS

Secondary Outcome Measures

Name	Time	Method
R0 resection rate	2 years	R0 resection rate
Overall Survival	2 years	OS
Detected lymph node number	2 years	Detected lymph node number

Trial Locations

Locations (11)

Department of Hepatobiliary and Pancreatic Surgery, The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital); 🇨🇳 Hefei, Anhui, China

Department of Hepatopancreatobiliary Surgery, Second Affiliated Hospital of Harbin Medical University,; 🇨🇳 Harbin, Heilongjiang, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China

Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Department of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People's Hospital; 🇨🇳 Hanzhou, Zhejiang, China

Department of Biliopancreatic Surgery, Huadong Hospital, Fudan University; 🇨🇳 Shanghai, 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, China

Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, China

West China Hospital; 🇨🇳 Chengdu, Sichuan, China