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Pancreatic Ductal AdenocarcinomaNCT03138213

Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy

A study testing Total laparoscopic pancreaticoduodenectomy and Open pancreaticoduodenectomy in people with Pancreatic Ductal Adenocarcinoma and Surgery, run by Tongji Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Introduction Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Read more about this study

Who is it for?
Any age
What is being tested?
Total laparoscopic pancreaticoduodenectomy and Open pancreaticoduodenectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
656 participants
Where
1 siteChina
Study dates
1 May 2018to 1 May 2022
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically proven periampullary cancer, including pancreatic cancer, bile duct cancer, duodenal cancer, et al.
  • Highly presumed malignancy with difficulties to obtain histological evidence.
  • Preoperative staging work up performed by upper abdomen enhanced CT scan.
  • The subject understands the nature of this trial and willing to comply.
  • Ability to provide written informed consent.
  • Patients treated with curative intent in accordance to international guidelines

Who cannot join

  • Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
  • Subjects undergoing left, central or total pancreatectomy.
  • Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4.
  • Synchronous malignancy in other organs.
  • Previous underwent pancreatic resections.
  • Palliative surgery.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Tongji Hospital

    Wuhan, Hubei, 430000

    Hang Zhang, M.D., +8613407148260, okashiiyo@126.com

    Recruiting

Other trials in China

About this study

Official title: Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy(TJDBPS01) a Multicenter Randomized Controlled Trial

Introduction Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the advent of hybrid-laparoscopy and recently with total laparoscopic surgery. Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated. Studies comparing these two surgical techniques are emerging, and large randomized controlled trials (RCTs) are lacking but are clearly required.

Methods and analysis TJDBPS01 is a multicentre, prospective, randomized controlled, parallel-group, superiority trial in fourteen centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay (LOS).

Ethics and dissemination The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organization. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings.

Being tested
Total laparoscopic pancreaticoduodenectomy, Open pancreaticoduodenectomy
Keywords
pancreaticoduodenectomy, surgical outcome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total laparoscopic pancreaticoduodenectomyProcedure or surgery

    Total laparoscopic pancreaticoduodenectomy

  • Open pancreaticoduodenectomyProcedure or surgery

    Open pancreaticoduodenectomy

Study groups in NCT03138213
Study groupRoleWhat they receive
TLPDExperimentalTtotal laparoscopic pancreaticoduodenectomy
Receives: Procedure: Total laparoscopic pancreaticoduodenectomy
OPDExperimentalOpen pancreaticoduodenectomy
Receives: Procedure: Open pancreaticoduodenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of stay

    Length of stay was defined as the postoperative time interval in days

    Measured: Up to 24 months

Secondary outcomes (6)

  1. Estimated blood loss

    The amount of blood loss during surgical procedure.

    Measured: Up to 24 months

  2. Operation time

    Time between first incision and last skin closure.

    Measured: Up to 24 months

  3. Mortality

    Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.

    Measured: Up to 24 months

  4. Complication rate

    Clavien-Dindo

    Measured: Up to 24 months

  5. CCI

    comprehensive complication index

    Measured: Up to 24 months

  6. 2 year survival

    Overall survival rate for 24 months after surgery

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2017
  2. Study start1 May 2018
  3. Primary completion1 May 2022 (estimated)
  4. Study completion1 May 2022 (estimated)

Resources

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
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
656 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03138213
Sponsor's protocol ID
TJDBPS01
Status last verified
Oct 2020
First submitted
7 Feb 2017
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Qin T, Zhang H, Pan S, Liu J, Li D, Chen R, Huang X, Liu Y, Liu J, Cheng W, Chen X, Zhao W, Li J, Tan Z, Huang H, Li D, Zhu F, Yu G, Zhou B, Zheng S, Tang Y, Ke J, Liu X, Chen B, Chen W, Ma H, Xu J, Liu Y, Lin R, Dong Y, Yu Y, Wang M, 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). Effect of Laparoscopic and Open Pancreaticoduodenectomy for Pancreatic or Periampullary Tumors: Three-year Follow-up of a Randomized Clinical Trial. Ann Surg. 2024 Apr 1;279(4):605-612. doi: 10.1097/SLA.0000000000006149. Epub 2023 Nov 15.

    PubMed 37965767

  • Wang M, Li D, Chen R, Huang X, Li J, Liu Y, Liu J, Cheng W, Chen X, Zhao W, Li J, Tan Z, Huang H, Li D, Zhu F, Qin T, Ma J, Yu G, Zhou B, Zheng S, Tang Y, Han W, Meng L, Ke J, Feng F, Chen B, Yin X, Chen W, Ma H, Xu J, Liu Y, Lin R, Dong Y, Yu Y, Liu J, 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 pancreatoduodenectomy for pancreatic or periampullary tumours: a multicentre, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol. 2021 Jun;6(6):438-447. doi: 10.1016/S2468-1253(21)00054-6. Epub 2021 Apr 27.

    PubMed 33915091

  • Zhang H, Feng Y, Zhao J, Chen R, Chen X, Yin X, Cheng W, Li D, Li J, Huang X, Li J, Liu J, Liu J, Liu Y, Tan Z, Zhao W, Huang H, Li D, Yu Y, Wang M, Qin R. Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial. BMJ Open. 2020 Feb 10;10(2):e033490. doi: 10.1136/bmjopen-2019-033490.

    PubMed 32047015

Questions about this trial

What is this clinical trial studying?

A study testing Total laparoscopic pancreaticoduodenectomy and Open pancreaticoduodenectomy in people with Pancreatic Ductal Adenocarcinoma and Surgery, 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 6 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of stay (time frame: Up to 24 months). 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 NCT03138213, which also lists 3 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 8 Oct 2020.

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