NCT04763642

Brief Summary

The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

February 13, 2021

Last Update Submit

January 17, 2026

Conditions

Pancreatic CancerBile Duct CancerAmpulla of Vater Cancer

Keywords

pancreatoduodenectomyminiinvasivecomplicationMorbidityMortality

Outcome Measures

Primary Outcomes (4)

  • Overall complications

    The proportion of all complications after operation accounted for the total number of patients

    up to 30 days

  • Pancreatic fistula

    The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.

    up to 30 days

  • Intra-abdominal bleeding

    he International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.

    up to 30 days

  • Intra-abdominal infection

    Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.

    up to 30 days

Secondary Outcomes (1)

  • Length of hospital stay (day)

    Up to postoperative 2 months

Other Outcomes (1)

  • progression-free survival

    Up to postoperative 3 years

Study Arms (3)

Laparoscopic Pancreaticoduodenectomy (LPD)

ACTIVE COMPARATOR
Procedure: pancreaticoduodenectomy

Robotic Pancreaticoduodenectomy (RPD)

ACTIVE COMPARATOR
Procedure: pancreaticoduodenectomy

Open Pancreaticoduodenectomy (OPD)

PLACEBO COMPARATOR
Procedure: pancreaticoduodenectomy

Interventions

pancreaticoduodenectomyPROCEDURE

Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation

Laparoscopic Pancreaticoduodenectomy (LPD)Open Pancreaticoduodenectomy (OPD)Robotic Pancreaticoduodenectomy (RPD)

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 21-75 years
  • Clinically/histologically established diagnosis of the cancer;
  • Preoperative imaging assessment is resectable or borderline resectable

You may not qualify if:

  • Benign tumors of the head of pancreas;
  • Distant metastasis;
  • Conversion to laparotomy;
  • Instrumental findings of the tumor process prevalence;
  • General somatic status on the ASA III-V scale;
  • Acute pancreatitis;
  • Hyperbilirubinemia above 60 μmol/L (3.51 mg/dl) ((normal range, 4-20 μmol/L)).
  • Patients with intraoperative positive express-histological presence of tumor growth along the border of the pancreas resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochapovsky Regional Clinical Hospital № 1

Krasnodar, Krasnodarskiy Kray, 350068, Russia

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsBile Duct Neoplasms

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2021

First Posted

February 21, 2021

Study Start

January 1, 2020

Primary Completion

April 19, 2023

Study Completion

April 30, 2024

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)