Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Cancer, Surgery, Laparoscopy

Intervention / Treatment
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* Procedure: Laparoscopic distal pancreatectomy
* Procedure: Open distal pancreatectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic distal pancreatectomy<br> | Procedure: Laparoscopic distal pancreatectomy<br>* 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).<br>|
| Active Comparator: Open distal pancreatectomy<br> | Procedure: Open distal pancreatectomy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Free Survival | RFS | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | OS | 2 years | 
| R0 resection rate | R0 resection rate | 2 years | 
| Detected lymph node number | Detected lymph node number | 2 years |