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

Sponsor

Govind Ballabh Pant Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03722732

Collaborator

(none)

Enrollment

Location

Arms

53.6

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Periampullary Carcinoma	Procedure: pancreaticoduodenectomy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma - A Randomized Clinical Trial

Actual Study Start Date :

Sep 11, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Open pancreaticoduedenectomy will include all the patients who will undergo open pancreaticoduodenectomy	Procedure: pancreaticoduodenectomy pancreaticoduodenectomy either laparoscopically or open will be done
Active Comparator: Laparoscopic pancreaticoduodenectomy will include all the patients undergoing laparoscopic pancreaticoduodenectomy	Procedure: pancreaticoduodenectomy pancreaticoduodenectomy either laparoscopically or open will be done

Arm

Intervention/Treatment

Active Comparator: Open pancreaticoduedenectomy

will include all the patients who will undergo open pancreaticoduodenectomy

Procedure: pancreaticoduodenectomy

pancreaticoduodenectomy either laparoscopically or open will be done

Active Comparator: Laparoscopic pancreaticoduodenectomy

will include all the patients undergoing laparoscopic pancreaticoduodenectomy

Procedure: pancreaticoduodenectomy

pancreaticoduodenectomy either laparoscopically or open will be done

Outcome Measures

Primary Outcome Measures

intraoperative blood loss in ml, quantitative [24 hours]
blood loss will be assessed with the help of a formula which uses preoperative and post operative hematocrit, blood volume and PCV

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	G B Pant Hospital	New Delhi	Delhi	India	110002

Sponsors and Collaborators

Govind Ballabh Pant Hospital

Investigators

Principal Investigator: H H Nag, MS, GBPant Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hirdaya H Nag, MS, Professor, Govind Ballabh Pant Hospital

ClinicalTrials.gov Identifier:

NCT03722732

Other Study ID Numbers:

F.1/IEC/MAMC/63/03/18/NO325

First Posted:

Oct 29, 2018

Last Update Posted:

Aug 2, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Study Results

No Results Posted as of Aug 2, 2021