A clinical trial to study the effects of two surgical modalities of treatment, open pancreatoduodenectomy and laparoscopic pancreatoduodenectomy in patients with periampullary and pancreatic head cancers.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2013/09/004016
• Date of registration: 23-09-2013
• Prospective Registration: No
• Primary sponsor: Gem Hospital Research Centre Private Limited
• Public title: A clinical trial to study the effects of two surgical modalities of treatment, open pancreatoduodenectomy and laparoscopic pancreatoduodenectomy in patients with periampullary and pancreatic head cancers.
• Scientific title: A Prospective randomized parallel group trial comparing Laparoscopic versus open Pancreatoduodenectomy in terms of severity short term of complications according to expanded Accordion Severity Grading System & overall outcomes - PLOT
• Date of first enrolment: 02-09-2013
• Target sample size: 60
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=7125
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Sandeep Sabnis
• Affiliation: Gem Hospital & Research Centre Private Limited

• Name: Dr P Senthilnathan
• Affiliation: Gem Hospital & Research Centre Private Limited

Key inclusion & exclusion criteria

Inclusion criteria: Adult males or females with a diagnosis of either of resectable Periampullary cancers.



Resectability in Periampullary cancer is defined radio logically as:

1. No evidence of metastasis

2. Radiological non-involvement of SMV & PV

3. Preserved fat planes between celiac axis, HA & SMA


Exclusion criteria: 1. Unresectable Tumor at surgery

2. Pancreatoduodenectomy with portal vein resection

3. Pancreatoduodenectomy for other diagnosis like cystic tumors or CCP with head mass

4. With prior Neoadjuvant treatment

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Resectable Periampullary malignant conditions like carcinoma of 1. Head of Pancreas 2. Duodenum 3. Lower end cholangiocarcinoma 4. Ampulla

Intervention(s)

Intervention1: Laparoscopic Pancreatoduodenectomy: Total laparoscopic resection of periampullary cancer.
Control Intervention1: Open Pancreatoduodenectomy
: comparison between two surgical procedures.
Control Intervention2: Open Pancreatoduodenectomy: Conventional open surgical approach to periampullary cancers.

Primary Outcome(s)

1. Complications according to the expanded Accordion Severity Grading System

2. Overall Outcome

Timepoint: 1. Discharge from hospital or death

2. Follow up at 6 months

Secondary Outcome(s)

1. Blood Loss

2. Operating Time

3. No of LN retrieved

4. Hospital Stay

5. Follow Up upto 6 months

Timepoint: 6 months

Secondary ID(s)

NIL

Source(s) of Monetary Support

Gem Hospital & Research Centre Private Limited, 45-A Pankaja Mill Road, Ramanathapuram, Coimbatore 641023 Tamil Nadu, India

Ethics review

Status: Approved
Approval date: 25/07/2013
Contact:

Gem Ethics committee