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Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma

Primary Purpose

Periampullary Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
pancreaticoduodenectomy
Sponsored by
Govind Ballabh Pant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periampullary Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • G B Pant HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Open pancreaticoduedenectomy

Laparoscopic pancreaticoduodenectomy

Arm Description

will include all the patients who will undergo open pancreaticoduodenectomy

will include all the patients undergoing laparoscopic pancreaticoduodenectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 2, 2018
Last Updated
July 30, 2021
Sponsor
Govind Ballabh Pant Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03722732
Brief Title
Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma
Official Title
Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Govind Ballabh Pant Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
the study is designed to compare the blood loss between laparoscopic vs open pancreaticoduodenectomy in a randomized clinical trial
Detailed Description
the study will assess the difference in the amount of blood loss in Lap vs Open WPD. the amount of blood loss will be calculated on the basis of a formula which takes pre operative and post operative hematocrit, PCV and blood volume into consideration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periampullary Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open pancreaticoduedenectomy
Arm Type
Active Comparator
Arm Description
will include all the patients who will undergo open pancreaticoduodenectomy
Arm Title
Laparoscopic pancreaticoduodenectomy
Arm Type
Active Comparator
Arm Description
will include all the patients undergoing laparoscopic pancreaticoduodenectomy
Intervention Type
Procedure
Intervention Name(s)
pancreaticoduodenectomy
Intervention Description
pancreaticoduodenectomy either laparoscopically or open will be done
Primary Outcome Measure Information:
Title
intraoperative blood loss in ml, quantitative
Description
blood loss will be assessed with the help of a formula which uses preoperative and post operative hematocrit, blood volume and PCV
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 1) Patients found to have unresectable disease on radiological investigation. 2) Patients with ASA grade 3 or above
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
H H Nag, MS
Phone
9718599260
Email
hirdayanag@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aditya sharma, MCH resident
Phone
9718599258
Email
adi.mamc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H H Nag, MS
Organizational Affiliation
GBPant Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
G B Pant Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hirdaya h nag, ms
Phone
91 11 23234242
Ext
5220
Email
hirdayanag@gmail.com
First Name & Middle Initial & Last Name & Degree
hirdaya h nag, ms

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma

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