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

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

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

Study Overview

• Status: Recruiting
• Conditions: Periampullary Carcinoma
• Intervention / Treatment: Procedure: pancreaticoduodenectomy

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: H H Nag, MS; Phone Number: 9718599260; Email: hirdayanag@gmail.com
• Study Contact Backup: Name: Aditya sharma, MCH resident; Phone Number: 9718599258; Email: adi.mamc@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110002
      • Recruiting
      • G B Pant Hospital
      • Contact: hirdaya h nag, ms; Phone Number: 5220 91 11 23234242; Email: hirdayanag@gmail.com
      • Principal Investigator: hirdaya h nag, ms

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Govind Ballabh Pant Hospital
• Investigators: Principal Investigator: H H Nag, MS, GBPant Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 11, 2018
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (ACTUAL): October 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: F.1/IEC/MAMC/63/03/18/NO325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No