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Role of Preoperative Radiotherapy in patients with Periampullary Tumors

Evaluating the Role of Preoperative Stereotactic Radiotherapy in Reducing Postoperative Pancreatic Fistula in Periampullary Tumors: A Phase II Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088767
Enrollment
21
Registered
2025-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: C250- Malignant neoplasm of head of pancreas

Interventions

Intervention1: Preoperative Stereotactic Radiotherapy in Periampullary Tumors: Patients with periampullary carcinoma who are receiving SBRT will be recruited by the investigator. Patients will undergo

Sponsors

AIIMS Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Literate 18 years or more aged ,ECOG less than 3,Resectable Periampullary malignancy patients with MPD less than 3mm and fit for Radiotherapy

Exclusion criteria

Exclusion criteria: 1.Patients undergoing PD for (suspected) PDAC, chronic pancreatitis, or benign neoplasms (eg, serous cyst) 2.Patients with (a history of) chronic pancreatitis 3.Contraindication for CECT.

Design outcomes

Primary

MeasureTime frame
Quantify the incidence of Grade B/C POPF as per ISGPS guidelinesTimepoint: 6 months

Secondary

MeasureTime frame
Assess the safety of preoperative SBRT by calculating the incidence of complications(CTCAE grade 3-5 taken as significant) within 30 days post-intervention.Timepoint: 30 days;Feasibility-Ability to deliver the Preoperative Stereotactic Radiotherapy without significant Delays or issues.Timepoint: 30 days;HPE assesement of samples from the pancreatic resection margin and uncinate processTimepoint: 30 days;Pancreatic texture in irradiated and non irradiated tissue determined intraoperatively by the pancreatic surgeon.Timepoint: Intra op

Countries

India

Contacts

Public ContactDrUtpal Anand

AIIMS Patna

utpalanand2@gmail.com8789146092

Outcome results

None listed

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