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Enrolling by Invitation

NCT Number: NCT05788029

Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

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

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Key information

Conditions

Periampullary Adenocarcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laparoscopic pancreaticoduodenectomy

Procedure

laparoscopic pancreaticoduodenectomy

Open Pancreaticoduodenectomy

Procedure

open pancreaticoduodenectomy

Primary outcomes

  1. length of hospital stay

    Time frame: 90 days

    defined as the number of nights spent in the hospital from the end of the surgical procedure until discharge or death

Secondary outcomes

  1. 1 year OS

    Time frame: 1 year

    1 year OS

  2. Operative time

    Time frame: From enrollment to the end of operation

    Total duration of the surgical procedure(minutes)

  3. Estimated blood loss

    Time frame: From enrollment to the end of operation

    Intraoperative estimated blood loss volume(ml).

  4. Intraoperative transfusion volume

    Time frame: From enrollment to the end of operation

    Volume of blood products transfused during the operation(ml)

  5. perioperative complication rate

    Time frame: 90 days

    proportion of patients experiencing postoperative complications)

  6. mortality rate and unplanned readmission rate

    Time frame: 90 days

    percentage of patients who die or require unplanned readmission within 90 days post-operation

  7. Karnofsky Performance Status (KPS) score

    Time frame: Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively

    Functional status assessment. Scores range from 0 to 100, with higher scores indicating better functional status.

    Unit of Measure: score (0-100)

  8. 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

    Functional status assessment. Scores range from 0 to 5, with lower scores indicating better functional status.

    Unit of Measure: score (0-5)

  9. Surgical costs

    Time frame: perioperatively

    Direct costs of the surgical procedure itself, including operating room fees, anesthesia fees, surgical supplies, and intraoperative medications.

    Unit of Measure: CNY

  10. Total hospitalization expenses

    Time frame: perioperatively

    Total inpatient costs from admission to discharge, including surgical costs, medications, bed charges, laboratory tests, imaging, nursing care, and other hospital services.

    Unit of Measure: CNY

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

  • Army Medical University, China
  • Chongqing General Hospital
  • First Affiliated Hospital of Harbin Medical University
  • Fudan University
  • Nanfang Hospital, Southern Medical University
  • Qilu Hospital of Shandong University
  • Shanxi Province Cancer Hospital
  • The Affiliated Hospital of Xuzhou Medical University
  • The First Affiliated Hospital of Dalian Medical University
  • The First Affiliated Hospital of University of South China
  • The Third Affiliated Hospital of Soochow University
  • Tianjin Medical University Cancer Institute and Hospital

Registry information

Acronym: NPPC

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Mar 28, 2023
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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