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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.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/004016
Enrollment
60
Registered
2013-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Laparoscopic Pancreatoduodenectomy: Total laparoscopic resection of periampullary cancer. Control Intervention1: Open Pancreatoduodenectomy : comparison between two surgical procedures

Sponsors

Gem Hospital Research Centre Private Limited
Lead Sponsor

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Blood Loss 2. Operating Time 3. No of LN retrieved 4. Hospital Stay 5. Follow Up upto 6 months Timepoint: 6 months—

Countries

India

Contacts

Public ContactDr P Senthilnathan

Gem Hospital & Research Centre Private Limited

drsandeepsabnis@gmail.com7598674643

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026