Clinical Trial: Standard Versus Extended Lymphadenectomy in Pancreatoduodenectomy for Patients With Pancreatic Head Adenocarcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Standard Versus Extended Lymphadenectomy in Pancreatoduodenectomy

Brief Summary: The aim of this study is to determine whether the performance of extended lymphadenectomy in association with pancreatoduodenectomy improves the long-term survival in patients with pancreatic head ductal adenocarcinoma.Half of participants will receive pancreatoduodenectomy with extended lymphadenectomy,while the other half will receive pancreatoduodenectomy with standard lymphadenectomy.

Detailed Summary:

Pancreatic cancer is a common malignant disease of the digestive system, and its incidence has been steadily increasing recently. Currently, the only potential curative treatment for pancreatic cancer is radical surgery. However, due to the peculiarity of the anatomical location of pancreas (in the retroperitoneum, surrounded by peripheral nerves and blood vessels) and its biological characteristics (neurotropic, highly malignant, and with probable skip metastasis), it is difficult to achieve R0 resection in patients with pancreatic cancer. High postoperative recurrence and distant metastasis rate are key factors in reducing long-term survival of patients with pancreatic cancer. The radical surgery modalities for pancreatoduodenectomy to achieve R0 resection involve extended lymphadenectomy, multivisceral resections, with or without simultaneous vein removals. Currently, the lymphadenectomy extent and approaches used to achieve R0 status are diverse. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) reached a consensus to strive to resect lymph nodes (LNs) 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b in standard lymphadenectomy for pancreatoduodenectomy. However, no consensus was reached on dissection of LN 16 due to variation in the literature and different expert opinions. On the current evidence, benefit of extended lymph node dissection seems to be outweighed by the risks. But deficiencies exist in the design of previous RCTs, such as insufficient sample size, lack of certain critical data for statistical analysis, inclusion of other pathological types of pancreatic neoplasms and variable retroperitoneal lymph node resection and nerve plexus dissection . Therefore, the power of evidence was low. Most studies report a high frequency of lymph node metastasis to LNs 13, 14, 17, 12 and 16 in pancreatic cancer, and tendency to metastasis from LNs 13, 14 to LN 16. In a lot of case reports
Sponsor: West China Hospital

Current Primary Outcome: 5-year overall survival rate [ Time Frame: 5 years ]

The percentage of patients that are alive at a 5 year


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Postoperative pancreatic fistula [ Time Frame: Within 30 days or before discharge ]
    ISGPS definition
  • Bile leakage [ Time Frame: Within 30 days or before discharge ]
    ISGLS definition
  • Delayed gastric emptying [ Time Frame: Within 30 days or before discharge ]
    ISGPS definition
  • Post-pancreatectomy haemorrhage [ Time Frame: Within 30 days or before discharge ]
    ISGPS definition
  • Intra-abdominal infection [ Time Frame: Within 30 days or before discharge ]
    Presence of fever, signs of peritonitis, high leukocytes count or positive peritoneal drainage fluid culture
  • Wound infection [ Time Frame: Within 30 days or before discharge ]
    Requiring invasive treatment, for example: positive wound exudate culture and requiring continuous re-open drainage or invasive treatment
  • Postoperative mortality [ Time Frame: Within 30 days or 60 days ]
    Death due to any cause before or at postoperative day 30 and 60
  • Quality of life [ Time Frame: 1 or 3 or 5 year ]
    EORTC QLQ-C30, according to the scoring manual published by the EORTC Quality of Life group
  • 5-year disease-free survival rate [ Time Frame: 5 years ]
    The percentage of patients alive without recurrence at a 5 year


Original Secondary Outcome: Same as current

Information By: West China Hospital

Dates:
Date Received: October 6, 2016
Date Started: January 2016
Date Completion: April 2021
Last Updated: October 6, 2016
Last Verified: October 2016