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Enrolling by invitation NCT05788029

Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

No phase Interventional Periampullary Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: laparoscopic pancreaticoduodenectomy, open pancreaticoduodenectomy.
Who it may be relevant to
Registry conditions: Periampullary Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma

Detailed description

The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma

Interventions

  • Procedure laparoscopic pancreaticoduodenectomy
    laparoscopic pancreaticoduodenectomy
  • Procedure open pancreaticoduodenectomy
    open pancreaticoduodenectomy

Primary outcome measures

  • length of hospital stay [Time frame: 90 days]
Secondary outcome measures (10)
  • 1 year OS [Time frame: 1 year]
  • Operative time [Time frame: From enrollment to the end of operation]
  • Estimated blood loss [Time frame: From enrollment to the end of operation]
  • Intraoperative transfusion volume [Time frame: From enrollment to the end of operation]
  • perioperative complication rate [Time frame: 90 days]
  • mortality rate and unplanned readmission rate [Time frame: 90 days]
  • Karnofsky Performance Status (KPS) score [Time frame: Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively]
  • Eastern Cooperative Oncology Group (ECOG) performance status score [Time frame: Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively]
  • Surgical costs [Time frame: perioperatively]
  • Total hospitalization expenses [Time frame: perioperatively]

Eligibility criteria

Inclusion criteria

  • Age between 18 years and 75 years.
  • Histologically confirmed NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence.
  • Patients feasible to undergo both LPD and OPD ac- cording 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 ac- cordance with clinical guidelines.

Exclusion criteria

  • Patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs.
  • Patients requiring left, central or total pancreatecto- my or other palliative surgery.
  • Preoperative American Society of Anaesthesiologists (ASA) score ≥4.
  • History of other malignant disease
  • Pregnant or breastfeeding women.
  • Patients with serious mental disorders
  • 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/m 2 .
  • Patients participating in any other clinical trials with- in 3 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical C — Wuhan

Publications

  • Li S, Pan S, Wang M, Huang X, Zhao W, Yu X, Chen X, Chen H, Dang X, Chen G, Wang L, An W, Zhang Q, Gao S, Guo S, Qin T, Zhang H, Qin R. Laparoscopic versus open pancreaticoduodenectomy for non-pancreatic periampullary adenocarcinomas: study protocol for a multicentre randomised controlled trial in China. BMJ Open. 2026 Jul 6;16(7):e117495. doi: 10.1136/bmjopen-2026-117495. PMID 42409398

Identifiers

NCT: NCT05788029 · TJDBPS14 · TJDBPS14

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗