RecruitingACTRN12616000854437

Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer


Sponsor

Shanghai Ruijin Pancreatic Disease Center

Enrollment

400 participants

Start Date

Jun 1, 2016

Study Type

Interventional

Conditions

Summary

The purpose of this study is to compare outcomes of patients undergoing standard or extended lymphadenectomy in pancreaticoduodenectomy for pancreatic ductal adenocarcinoma


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This surgical trial is comparing two different extents of lymph node removal during an operation called a pancreaticoduodenectomy (Whipple procedure) for cancer of the head of the pancreas. In the standard approach, surgeons remove a certain number of nearby lymph nodes. In the extended approach, more lymph nodes are removed to try to capture any cancer spread. The trial aims to find out whether removing more lymph nodes improves survival without causing more complications. You may be eligible if: - You are between 18 and 80 years old - You have been diagnosed with pancreatic ductal adenocarcinoma (a type of pancreatic cancer) - You have signed informed consent - Your surgery is expected to remove the tumour completely (radical resection) You may NOT be eligible if: - You have a different type of pancreatic cancer - You have received anti-cancer treatment (chemotherapy or radiation) before surgery - Your cancer has already come back (recurrence) - You have severe liver, lung, or kidney dysfunction - Your bilirubin (liver enzyme) level is very high (above 250 micromol/L) - Your cancer has spread to distant organs (Stage IV) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Pancreaticoduodenectomy for Pancreatic ductal adenocarcinoma with standard or extended lymphadenectomy undergoing by the surgeons from Ruijin Hospital standard lymphadenectomy includes standard lymp

Pancreaticoduodenectomy for Pancreatic ductal adenocarcinoma with standard or extended lymphadenectomy undergoing by the surgeons from Ruijin Hospital standard lymphadenectomy includes standard lymphadenectomy and No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes stations extended lymphadenectomy includes No8p 12a 12p 14c 14d 16 lymph nodes stations and those in standard lymphadenectomy( No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b) The details of all lymph nodes stations are described as below: No. 5, Suprapyloric lymph nodes; No. 6, infrapyloric lymph nodes; No. 8a, lymph nodes in the anterosuperior group along the common hepatic artery; No. 8p, lymph nodes in the posterior group along the common hepatic artery; No. 12a, lymph nodes along the hepatic artery; No. 12p, lymph nodes along the portal vein; No. 12b, lymph nodes along the bile duct; No. 12c (located next to 12b), lymph nodes around the cystic duct; No. 13a, lymph nodes on the posterior aspect of the superior portion of the head of the pancreas; No. 13b, lymph nodes on the posterior aspect of the inferior portion of the head of the pancreas; No. 14, lymph nodes along the superior mesenteric artery (a & b. right lateral side, c & d. left lateral side ); No. 16, lymph nodes around the abdominal aorta;.No. 17a, lymph nodes on the anterior surface of the superior portion of the head of the pancreas; No. 17b, lymph nodes on the anterior surface of the inferior portion of the head of the pancreas


Locations(1)

Shanghai, China

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