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2016-01
2021-02
2021-04
320
NCT02928081
West China Hospital
West China Hospital
INTERVENTIONAL
Standard Versus Extended Lymphadenectomy in Pancreatoduodenectomy for Patients With Pancreatic Head Adenocarcinoma
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.
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, only nodal station 16a2 and 16b1 were positive in LN 16. This study is performed to confirm whether pancreatoduodenectomy with extended lymphadenectomy could improve survival. Subjects undergoing surgery will be randomized to pancreatoduodenectomy with extended lymphadenectomy including nerve tissues around CHA and the SMA and nodes around the celiac trunk and SMA (No.16a2, 16b1) versus standard pancreatoduodenectomy. Subjects will be followed every three months for survivorship or death. The primary endpoint of 5-year overall or disease-free survival survival will be determined at five year post surgery.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-10-06 | N/A | 2016-10-06 |
2016-10-06 | N/A | 2016-10-07 |
2016-10-07 | N/A | 2016-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Extended lymphadenectomy In addition to the standard lymphadenectomy, the nerve tissues around CHA and the SMA and nodes around the celiac trunk and SMA (No.16a2, 16b1) must be dissected. Retroperitoneal lymphatic tissue, nerves and connective tissue range from the hepatic portal | PROCEDURE: Extended lymphadenectomy
|
| OTHER: Standard lymphadenectomy Lymph node dissection includes the superior and inferior pyloric nodes (LN5, LN6), anterior and posterior nodes along the common hepatic artery (CHA) (LN8a, 8b), nodes along the common hepatic duct, common bile duct and cystic duct (LN12b1, 12b2, 12c), po | PROCEDURE: Standard lymphadenectomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 5-year overall survival rate | The percentage of patients that are alive at a 5 year | 5 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Postoperative pancreatic fistula | ISGPS definition | Within 30 days or before discharge |
| Bile leakage | ISGLS definition | Within 30 days or before discharge |
| Delayed gastric emptying | ISGPS definition | Within 30 days or before discharge |
| Post-pancreatectomy haemorrhage | ISGPS definition | Within 30 days or before discharge |
| Intra-abdominal infection | Presence of fever, signs of peritonitis, high leukocytes count or positive peritoneal drainage fluid culture | Within 30 days or before discharge |
| Wound infection | Requiring invasive treatment, for example: positive wound exudate culture and requiring continuous re-open drainage or invasive treatment | Within 30 days or before discharge |
| Postoperative mortality | Death due to any cause before or at postoperative day 30 and 60 | Within 30 days or 60 days |
| Quality of life | EORTC QLQ-C30, according to the scoring manual published by the EORTC Quality of Life group | 1 or 3 or 5 year |
| 5-year disease-free survival rate | The percentage of patients alive without recurrence at a 5 year | 5 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Xubao Liu, MD Phone Number: 86-28-85422474 Email: liuxb2011@126.com |
Study Contact Backup Name: Junjie Xiong, MD Phone Number: 86-28-85422474 Email: junjiex2011@126.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
