NCT03747588

Brief Summary

Minimally invasive pancreaticoduodenectomy remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing minimally-invasive with open pancreaticoduodenectomy, especially for malignant tumors.The aim of this study was to compare minimally invasive and open pancreatoduodenectomy for short-term outcomes and long-term follow-up in a randomized trial.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress74%
Dec 2018Dec 2028

First Submitted

Initial submission to the registry

November 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Expected
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

5 years

First QC Date

November 16, 2018

Last Update Submit

September 30, 2022

Conditions

Pancreatic CarcinomaSurgery

Keywords

minimally-invasive pancreaticoduodenectomyopen pancreaticoduodenectomypancreatic cancer

Outcome Measures

Primary Outcomes (4)

  • Overall complications

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

    Up to postoperative 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 postoperative 30 days

  • Intra-abdominal bleeding

    The 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 postoperative 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 postoperative 30 days

Secondary Outcomes (1)

  • Length of hospital stay (day)

    Up to postoperative 2 weeks

Other Outcomes (1)

  • progression-free survival

    Up to postoperative 5 years

Study Arms (2)

Minimally-invasive Pancreaticoduodenectomy

EXPERIMENTAL

MIPD

Procedure: Minimally-invasive pancreaticoduodenectomy

Open Pancreaticoduodenectomy

PLACEBO COMPARATOR

OPD

Other: Open pancreaticoduodenectomy

Interventions

Minimally-invasive pancreaticoduodenectomyPROCEDURE

Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor

Minimally-invasive Pancreaticoduodenectomy
Open pancreaticoduodenectomyOTHER

Open pancreaticoduodenectomy for resection of pancreatic tumor

Open Pancreaticoduodenectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: \>18yr, \<75yr
  • Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy
  • Preoperative imaging assessment is resectable or borderline resectable

You may not qualify if:

  • Benign tumors of the head of pancreas
  • Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis.
  • conversion to laparotomy because of intraoperative difficulty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Menghua Dai, MD

CONTACT

+861069152600DaiMH@pumch.cn

Study Design

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

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 20, 2018

Study Start

December 1, 2018

Primary Completion

December 1, 2023

Study Completion (Estimated)

December 30, 2028

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

CN(1)