Pancreatic CarcinomaNCT03785743
Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma
A study testing TLPD Surgery and OPD Surgery in people with Pancreatic Carcinoma and Laparoscopic, run by Tongji Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Carcinoma, Laparoscopic, Pancreaticoduodenectomy
- What is being tested?
- TLPD Surgery and OPD Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 years and 75 years.
- Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence.
- Patients feasible to undergo both LPD and OPD according to MDT evaluations.
- Patients understanding and willing to comply with this trial.
- Provision of written informed consent before patient registration.
- Patients meeting the curative treatment intent in accordance with clinical guidelines.
Who cannot join
- Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
- Patients requiring left, central or total pancreatectomy or other palliative surgery.
- Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4.
- History of other malignant disease.
- Pregnant or breast-feeding women.
- Patients with serious mental disorders.
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- Patients treated with neoadjuvant therapy.
- Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
- Body mass index > 35 kg/m2.
- Patients participating in any other clinical trials within 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Junfang O Zhao, MD, PhD, +8615827539076, zhaojunfang2012@hotmail.com
About this study
Official title: Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial
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.
- Conditions
- Pancreatic Carcinoma, Laparoscopic, Pancreaticoduodenectomy
- Being tested
- TLPD Surgery, OPD Surgery
- Keywords
- Pancreatic Carcinoma, Laparoscopic, Pancreaticoduodenectomy, Survival
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLPD SurgeryProcedure or surgery
TLPD
OPD SurgeryProcedure or surgery
OPD
| Study group | Role | What they receive |
|---|---|---|
| TLPD | Experimental | Total laparoscopic pancreaticoduodenectomy for pancreatic cancer Receives: Procedure: TLPD Surgery |
| OPD | Experimental | Open pancreaticoduodenectomy for pancreatic cancer Receives: Procedure: OPD Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
5-year overall survival
Measured: 5 year
Secondary outcomes (7)
overall survival
the interval between the day of surgery and the day of death for various reasons
Measured: 5 years
disease-free survival
the interval between the day of surgery and the day of tumour recurrence
Measured: 5 years
90-day mortality
the percentage of patients who died within 90 days postoperatively
Measured: 90 days
complication rate
complications related to PD
Measured: 90 days
comprehensive complication index
calculated as the sum of all complications that are weighted for their severity
Measured: 90 days
length of stay
the number of nights spent in the hospital from the end of the surgical procedure until discharge or death
Measured: 90 days
intraoperative indicators
description of the patients' intraoperative condition relating to the safety of patients
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Mar 2019
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CarcinomaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, The Second Hospital of Hebei Medical University, The Affiliated Hospital of Xuzhou Medical University, Xinqiao Hospital of Chongqing, Hunan Provincial People's Hospital, The First Hospital of Jilin University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Third Affiliated Hospital of Soochow University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of North Sichuan Medical College, First Affiliated Hospital of Chongqing Medical University, Peking Union Medical College Hospital, Henan Provincial People's Hospital, Sir Run Run Shaw Hospital, Fujian Medical University Union Hospital, Fudan University
- Responsible party
- Principal investigator, Renyi Qin, Tongji Hospital
- Investigators
- Renyi Qin, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785743
- Sponsor's protocol ID
- TJDBPS07
- Status last verified
- Feb 2022
- First submitted
- 20 Dec 2018
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang M, Pan S, Qin T, Xu X, Huang X, Liu J, Chen X, Zhao W, Li J, Liu C, Li D, Liu J, Liu Y, Zhou B, Zhu F, Ji S, Cheng H, Li Z, Li J, Tang Y, Peng X, Yu G, Chen W, Ma H, Xiong Y, Meng L, Lu P, Zhang Z, Yu X, Zhang H, Qin R. Short-Term Outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma: A Randomized Clinical Trial. JAMA Surg. 2023 Dec 1;158(12):1245-1253. doi: 10.1001/jamasurg.2023.5210.
PubMed 37878305Pan S, Qin T, Yin T, Yu X, Li J, Liu J, Zhao W, Chen X, Li D, Liu J, Li J, Liu Y, Zhu F, Wang M, Zhang H, Qin R; Minimally Invasive Treatment Group in the Pancreatic Disease Branch of China's International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM). Laparoscopic versus open pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: study protocol for a multicentre randomised controlled trial. BMJ Open. 2022 Apr 4;12(4):e057128. doi: 10.1136/bmjopen-2021-057128.
PubMed 35379633
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03785743
- Acronym / sponsor ID
- TJDBPS07
- Conditions
- Pancreatic Carcinoma, Laparoscopic, Pancreaticoduodenectomy
- Keywords
- Pancreatic Carcinoma, Laparoscopic, Pancreaticoduodenectomy, Survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, The Second Hospital of Hebei Medical University, The Affiliated Hospital of Xuzhou Medical University, Xinqiao Hospital of Chongqing, Hunan Provincial People's Hospital, The First Hospital of Jilin University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Third Affiliated Hospital of Soochow University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of North Sichuan Medical College, First Affiliated Hospital of Chongqing Medical University, Peking Union Medical College Hospital, Henan Provincial People's Hospital, Sir Run Run Shaw Hospital, Fujian Medical University Union Hospital, Fudan University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TLPD | Experimental | Procedure: TLPD SurgeryTotal laparoscopic pancreaticoduodenectomy for pancreatic cancer |
| OPD | Experimental | Procedure: OPD SurgeryOpen pancreaticoduodenectomy for pancreatic cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 years and 75 years.
- Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence.
- Patients feasible to undergo both LPD and OPD according to MDT evaluations.
- Patients understanding and willing to comply with this trial.
- Provision of written informed consent before patient registration.
Key exclusion criteria (10 listed)
- Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
- Patients requiring left, central or total pancreatectomy or other palliative surgery.
- Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4.
- History of other malignant disease.
- Pregnant or breast-feeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLPD SurgeryTLPD | Procedure or surgery | TLPD |
| OPD SurgeryOPD | Procedure or surgery | OPD |
Primary outcome
5-year overall survival
Time frame: 5 year
5-year overall survival
7 secondary outcomes
overall survival
Time frame: 5 years
disease-free survival
Time frame: 5 years
90-day mortality
Time frame: 90 days
complication rate
Time frame: 90 days
comprehensive complication index
Time frame: 90 days
length of stay
Time frame: 90 days
intraoperative indicators
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 37878305Wang M, Pan S, Qin T, Xu X, Huang X, Liu J, Chen X, Zhao W, Li J, Liu C, Li D, Liu J, Liu Y, Zhou B, Zhu F, Ji S, Cheng H, Li Z, Li J, Tang Y, Peng X, Yu G, Chen W, Ma H, Xiong Y, Meng L, Lu P, Zhang Z, Yu X, Zhang H, Qin R. Short-Term Outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma: A Randomized Clinical Trial. JAMA Surg. 2023 Dec 1;158(12):1245-1253. doi: 10.1001/jamasurg.2023.5210.
- Derived from this study: PubMed 35379633Pan S, Qin T, Yin T, Yu X, Li J, Liu J, Zhao W, Chen X, Li D, Liu J, Li J, Liu Y, Zhu F, Wang M, Zhang H, Qin R; Minimally Invasive Treatment Group in the Pancreatic Disease Branch of China's International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM). Laparoscopic versus open pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: study protocol for a multicentre randomised controlled trial. BMJ Open. 2022 Apr 4;12(4):e057128. doi: 10.1136/bmjopen-2021-057128.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renyi Qin principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLPD Surgery and OPD Surgery in people with Pancreatic Carcinoma and Laparoscopic, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renyi Qin (+8602783665314, 172356995@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785743, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.