NCT03722732

Brief Summary

the study is designed to compare the blood loss between laparoscopic vs open pancreaticoduodenectomy in a randomized clinical trial

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 11, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

4.2 years

First QC Date

October 2, 2018

Last Update Submit

July 30, 2021

Conditions

Periampullary Carcinoma

Outcome Measures

Primary Outcomes (1)

  • intraoperative blood loss in ml, quantitative

    blood loss will be assessed with the help of a formula which uses preoperative and post operative hematocrit, blood volume and PCV

    24 hours

Study Arms (2)

Open pancreaticoduedenectomy

ACTIVE COMPARATOR

will include all the patients who will undergo open pancreaticoduodenectomy

Procedure: pancreaticoduodenectomy

Laparoscopic pancreaticoduodenectomy

ACTIVE COMPARATOR

will include all the patients undergoing laparoscopic pancreaticoduodenectomy

Procedure: pancreaticoduodenectomy

Interventions

pancreaticoduodenectomyPROCEDURE

pancreaticoduodenectomy either laparoscopically or open will be done

Laparoscopic pancreaticoduodenectomyOpen pancreaticoduedenectomy

Eligibility Criteria

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

You may qualify if:

  • Patients of both the sex aged between \>18 years.
  • Patients with a diagnosis of resectable periampullary carcinoma on imaging.
  • Patients with ASA grade 1 or 2

You may not qualify if:

  • \) Patients found to have unresectable disease on radiological investigation. 2) Patients with ASA grade 3 or above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G B Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

RECRUITING

MeSH Terms

Interventions

Pancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • H H Nag, MS

    GBPant Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

H H Nag, MS

CONTACT

9718599260hirdayanag@gmail.com

Aditya sharma, MCH resident

CONTACT

9718599258adi.mamc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 29, 2018

Study Start

September 11, 2018

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)