Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT) (PLOT)

September 14, 2015 updated by: GEM Hospital & Research Center

A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions

The aim of this study is to compare the two surgical approaches namely laparoscopic pancreatoduodenectomy and open pancreatoduodenectomy for management of periampullary and pancreatic head cancers in terms of parameters like hospital stay, pathological radicality, complication rate, peri-operative and post operative outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic pancreatoduodenectomy (LPD) although technically difficult, requiring high degree of expertise, has shown equal efficacy in terms of complications, oncological safety & overall outcome to that of open pancreatoduodenectomy (OPD) with advantages of minimally invasive surgery like decreased blood loss, reduced pain, shorter hospital stay & early return to work.

Although current literature from various centres supports its use, the studies done so far are, case comparisons of either small sample of population or non-randomized trials. According to our knowledge, a randomized trial analyzing open versus laparoscopic pancreatoduodenectomy (PD) in terms of complications and outcome, has not been reported. With this current study we will try to address this issue.

This study is a prospective, randomized, parallel group, controlled trail comparing laparoscopic versus open pancreatoduodenectomy in relation to the hospital stay, peri-operative parameters, pathological radicality & complications.

This is a single institute based trial, being conducted at GEM hospital and research center, Coimbatore, TN, India. The trial has been approved by the GEM Hospital ethical committee.

Through this trial we are planning to enroll patients having resectable periampullary and pancreatic head malignant lesion at diagnosis. After full assessment, optimization, approval of hospital tumor board with informed consent, those patients selected for surgical therapy with curative intention, will be randomized using computer generated random numbers either into Laparoscopic Pancreatoduodenectomy (LPD) group or Open Pancreatoduodenectomy (OPD) group.

The details of surgery, blood loss, operating time, conversion if any as well as details of postoperative events, hospital stay & complications if any will be recorded in proforma. Protocols for adjuvant therapy according to pathological stages will be followed. These patients will be reviewed at 1, 3 and 6 months post-surgery.

The primary outcome will be hospital stay at time of discharge or death. The secondary outcomes will be Blood Loss, Operating Time, Complications and pathological radicality at discharge or death. The trial is expected to last for a duration of 2 years.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641045
        • Gem Hospital & Research Centre Private Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult males or females with a diagnosis of either of resectable Periampullary and pancreatic head cancers with

    1. No evidence of metastasis
    2. Radiological non-involvement of Superior Mesenteric Vein & Portal Vein
    3. Preserved fat planes between celiac axis, Hepatic Artery & Superior Mesenteric Artery

Exclusion Criteria:

  1. Unresectable Tumor at surgery
  2. Pancreatoduodenectomy for other diagnosis like cystic tumors or chronic calcific pancreatitis with head mass
  3. With prior Neoadjuvant treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Laparoscopic Surgery
patients will be randomized to laparoscopic pancreatoduodenectomy group
Procedure: Laparoscopic surgery
laparoscopic pancreatoduodenectomy
Other Names:
  • laparoscopic pancreatoduodenectomy
  • whipple's operation
  • pylorus preserving pancreatoduodenectomy
ACTIVE_COMPARATOR: Open Surgery
Patients will be randomized to Open pancreatoduodenectomy
Procedure: Open surgery
pancreatic head resection by open method
Other Names:
  • Whipple's operation, pancreatoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital Stay
Time Frame: discharge from hospital or death which ever earlier recorded over 100 days from date of admission
discharge from hospital or death which ever earlier recorded over 100 days from date of admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: within 24 hours of primary surgical procedure
Blood loss at surgery
within 24 hours of primary surgical procedure
Pathological radicality
Time Frame: within 7 days of surgery
Two specimen arms will be compared on the basis of extent of pathological clearance like margin positivity rate, number of lymph nodes, average length of surgical margin
within 7 days of surgery
Operating time
Time Frame: At completion of the primary surgical procedure, recorded over 48 hrs
Time calculated in minutes
At completion of the primary surgical procedure, recorded over 48 hrs
Complication rate
Time Frame: 100 days from date of surgery
Pancreatic surgery specific complications will be accessed by International Study group for pancreatic surgery ( ISGPS) classification like post operative pancreatic fistula ( POPF). Other complications will be accessed by Clavien Dindo Classification system
100 days from date of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GEM Hospital & Research Center

Investigators

  • Principal Investigator: Senthilnathan Palanisamy, MS, DNB, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
  • Study Director: Palanivelu Chinnusamy, MS, MCh, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
  • Study Director: Sandeep Sabnis, MS, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (ESTIMATE)

March 7, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLOT
  • CTRI/2013/09/004016 (REGISTRY: Clinical Trials Registry India)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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