ClinicalTrials.gg
Enrolling by invitationNCT06685939TDCBLAPUpdated Nov 13, 2024

The Differences of Complications Between LPD(Laparoscopic Pancreaticoduodenectomy) and OPD(Open Pancreaticoduodenectomy)

An observational study in Pancreatic Neoplasms, sponsored by Zhijun Bao. Enrolling by invitation at 1 site in China. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-11-13.

Sponsored by Zhijun Bao · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
220
Ages
19 Years and older
Sex
All
01

Study summary

Main objective: This project intends to design a simulated RCT project and clinically relevant RCT study to target, selecting the study titled "Short-Term outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma: A Randomized Clinical Trial (Short-term Outcomes of Laparoscopic versus Open Pancreaticoduodenectomy in Patients with Pancreatic Ductal Adenocarcinoma)", use the cases in the Pancreatic Cancer Special Disease Cohort Database, compare the differences in complications and short-term prognosis between patients with pancreatic cancer after laparoscopic and open pancreaticoduodenectomy, investigate the efficacy and safety of laparoscopic pancreaticoduodenectomy, and provide the basis and reference of real-world data for clinical relevant studies. Secondary objective: To predict the incidence of postoperative complications and short-term outcomes of pancreatic cancer patients by comparing the difference of complications and short-term prognosis between laparoscopic and open pancreaticoduodenectomy, and to improve the treatment power of patients scheduled for surgery and postoperative patients.

02

Conditions studied

  • Pancreatic Neoplasms

Keywords

  • pancreatic cancer
  • LPD
  • OPD
  • complication
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In context

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

This study's planned enrollment of 220 is close to the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Zhijun Bao is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients treated with LPD or OPD for pancreatic cancer in Huadong Hospital from 1,January 2020 to 31,December 2022

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: 18 years old, with no gender limit;
  • confirmed or clinically diagnosed as pancreatic cancer by MDT (multidisciplinary team), without histopathological evidence;
  • Patients may receive LPD or OPD according to the MDT evaluation;
  • Patients understand and are willing to comply with the trial;
  • Signed written before patient enrollment;
  • Patients who meet the clinical guidelines for intent to treat.
  • Those who met each of the above criteria were included in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients with distant found before or during surgery, including peritoneal, liver, distant lymph node metastasis, and other organ involvement;
  • Patients who need pancreatic neck or pancreatic tail, total pancreatic resection or other palliative surgery;
  • Preoperative anesthesia of 4 points;
  • A history of other malignant tumors;
  • Pregnant or lactating women;
  • Patients with severe mental disorders;
  • MDT evaluates patients with vascular invasion and requiring vascular resection based on abdominal imaging data;
  • Patients who have participated in other clinical trials within 3 months. Those who meet any of the above criteria were not included in the study.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
220 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • OPD

    The patients who received the OPD

    Procedure: LPD

Interventions

  • ProcedureLPD

    The patients who received the LPD

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What researchers measure

Primary outcomes

  1. Overall survive

    Time frame: from the day after surgery to 3 years

  2. complication

    any possible symptoms caused by surgery

    Time frame: during the days Postoperative up to 1 year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Dec 2022, 35 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2024
First posted
Nov 13, 2024
StartActual
Jan 1, 2020
Primary completionActual
Dec 31, 2022
CompletionEst.
Jul 31, 2025
Last update
Nov 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06685939
Lead sponsor
Zhijun Bao
Collaborators
Ruijin Hospital, The Shanghai Jiao Tong University Medical School
Responsible party
Zhijun Bao (Dean, Fudan University) — Sponsor-investigator
First posted
Nov 13, 2024
Start date
Jan 1, 2020
Primary completion
Dec 31, 2022
Completion
Jul 31, 2025 (estimated)
Last update
Nov 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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