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Analysis of complications in patients undergoing surgery for cancer of the pancreas and duodenum in a referral cancer hospital.

Surgical outcomes in pancreatoduodenectomy- an observational prospective analysis in a tertiary referral cancer center. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/06/068749
Enrollment
94
Registered
2024-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: C170- Malignant neoplasm of duodenum Health Condition 2: C248- Malignant neoplasm of overlappingsites of biliary tract Health Condition 3: C258- Malignant neoplasm of overlappingsites of pancreas Health Condition 4: C259- Malignant neoplasm of pancreas, unspecified Health Condition 5: D490- Neoplasm of unspecified behavior of digestive system

Interventions

Intervention1: NOT APPLICABLE: NOT APPLICABLE Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Sponsors

Mahamana Pandit Madan Mohan Malaviya Cancer Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive patients undergoing pancreatoduodenectomy during the study period, with: 1. Age 18 to 80 years 2. ECOG less than 3 3. Patient undergoing pancreatoduodenectomy surgery for cancer involving duodenum, duodenal ampulla, bile duct, and head of pancreas.

Exclusion criteria

Exclusion criteria: 1. Patients who do not undergo complete resection and pancreatobiliaryenteric reconstruction. 2. Patients who are found to be metastatic on exploration.

Design outcomes

Primary

MeasureTime frame
Rate and severity of postoperative complications esp. Clavein-Dindo (CD) classification, esp. CD =3 rates which includes POPF rates (postoperative pancreatic fistula), DGE rates (delayed gastric emptying), bile leak rates, postoperative hemorrhage rates, and re-exploration rates, SSI (surgical site infection) rates, pulmonary complications rate, cardiac complications rate, and renal complications rate.Timepoint: 30 days post surgery

Secondary

MeasureTime frame
30-day mortality Timepoint: 30 days post surgery;90- day mortality Timepoint: 90 days post surgery;Length of hospital stay/ ICU stay Timepoint: 90 days post surgery;Positive Intraop Bile culture and sensitivity. Timepoint: 30 days post surgery;Post neoadjuvant exploration rates Timepoint: 30 days post surgery;Postoperative histopathology stage and site of tumor, pathological diagnosis, Number of lymph nodes dissected, number of positive lymph nodes, lympho-vascular infiltration, perineural infiltration, perivascular infiltration, resection status (R0, R1, R2). Timepoint: 30 days post surgery;Presence and type of preoperative biliary drainage and interval between drainage and surgery. Timepoint: 30 days post surgery;Re-admission ratesTimepoint: 90 days post surgery

Countries

India

Contacts

Public ContactDr Mayank Tripathi

Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi

irfan908@gmail.com918754845970

Outcome results

None listed

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