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A prospective, randomized study comparing 2 techniques of pancreatoduodenectomy in pancreatic cancer with special focus on resection margins and medium term survival outcomes

Posterior (SMA- first) Approach vs. standard pancreatoduodenectomy in patients with periampullary tumors and pancreatic cancer with special focus on circumferential resection margins and medium term survival outcome: a prospective randomized controlled trial. - SMA first RCT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/10/004045
Enrollment
150
Registered
2013-10-04
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- Patients with resetable/ borderline resectable pancreatic head cancer with good performance status.

Interventions

Intervention1: Conventional pancreatoduodenectomy (PD)surgery, PD surgery using the posterior superior mesenteric artery first technique.: Patients with resectable pancreatic head cancer Control arm:

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Good performance status (Eastern Cooperative Oncology Group performance status 0, 1, 2) 2. Age: 18-75 years 3. Patients with a diagnosis of i) Resectable carcinoma head of pancreas ii) Resectable periampullary tumors iii) Patients with borderline resectability (for both tumor categories) will also be included in both arms.

Exclusion criteria

Exclusion criteria: 1. Patient unwilling to consent for the study 2. Metastatic or unresectable disease 3. Patient undergoing total pancreatectomy

Design outcomes

Primary

MeasureTime frame
Primary outcome 1.R0 resection rate in the 2 arms (LEEDS Protocol). 2. Number of lymph nodes harvested. Timepoint: Patient accrual: 1.5-2 years Follow up: at least 6 months post resection Prospective clinical and path data collection Interim analysis at 2 years—

Secondary

MeasureTime frame
1.Operative time 2.Incidence of postoperative complications. 3.Recurrence-free and overall survival.Timepoint: Prospective data collection Minimum follow up of 6 months Maximum follow up till disease recurrence/death—

Countries

India

Contacts

Public ContactSujoy Pal

All India Institute of Medical Sciences

sujoypal@hotmail.com9868045609

Outcome results

None listed

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