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2019-03-01
2027-03-01
2027-05-01
200
NCT03785743
Tongji Hospital
Tongji Hospital
INTERVENTIONAL
Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma
Background: Pancreatic cancer (PC) is one of the most aggressive malignant neoplasms with poor outcomes. Pancreatoduodenectomy (PD) is the only curative treatment for PC. Minimally invasive surgery has been progressively developed, first with the advent of hybrid-laparoscopy and recently with the total laparoscopy surgeries, but a number of issues are currently being debated, including the superiority between total laparoscopic pancreaticoduodenectomy (TLPD)and the open pancreaticoduodenectomy (OPD). Studies comparing these two surgery techniques are merging and randomized controlled trials (RCT) are lacking but clearly required. Methods/design: TJDBPS07 is a multicenter prospective, randomized controlled, trial comparing TLPD and OPD in pancreatic cancers. A total of 200 patients with pancreatic cancer underwent PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after surgery (ERAS) pattern. The trial's aim is to exploring the overall survival (OS), disease free survival (DFS) and quality of life. The duration of the entire trial is seven years including prearrangement, a presumably five-year follow-up and analyses. Discussion: Despite the fact there are several RCTs comparing minimally invasive pancreaticoduodenectomy (MIPD) and Open approach or LPD versus OPD. This trial will be the first comparing TLPD and OPD in a large multicenter setting. TJDBPS01 trial is hypothesized to assess whether TLPD has superiority over OPD in recovery and other aspects.
N/A
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 |
|---|---|---|
2018-12-20 | N/A | 2022-02-27 |
2018-12-20 | N/A | 2022-03-02 |
2018-12-24 | N/A | 2022-02 |
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:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: TLPD Total laparoscopic pancreaticoduodenectomy for pancreatic cancer | PROCEDURE: TLPD Surgery
|
| EXPERIMENTAL: OPD Open pancreaticoduodenectomy for pancreatic cancer | PROCEDURE: OPD Surgery
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 5-year overall survival | 5-year overall survival | 5 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| overall survival | the interval between the day of surgery and the day of death for various reasons | 5 years |
| disease-free survival | the interval between the day of surgery and the day of tumour recurrence | 5 years |
| 90-day mortality | the percentage of patients who died within 90 days postoperatively | 90 days |
| complication rate | complications related to PD | 90 days |
| comprehensive complication index | calculated as the sum of all complications that are weighted for their severity | 90 days |
| length of stay | the number of nights spent in the hospital from the end of the surgical procedure until discharge or death | 90 days |
| intraoperative indicators | description of the patients' intraoperative condition relating to the safety of patients | 90 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Renyi Qin Phone Number: +8602783665314 Email: 172356995@qq.com |
Study Contact Backup Name: Hag Zhang Phone Number: +8602783665314 Email: 172356995@qq.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
