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A randomised study to study the impact of Pancreaticodudoenectomy done using ePTFE on pancreatic fistula

Impact of ePTFE Suture for Pancreaticojejunosotmy on Clinically Relevant Post-operative Pancreatic Fistula after Pancreatoduodenectomy: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080071
Enrollment
60
Registered
2025-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: D132- Benign neoplasm of duodenum Health Condition 2: D136- Benign neoplasm of pancreas Health Condition 3: C240- Malignant neoplasm of extrahepaticbile duct Health Condition 4: C241- Malignant neoplasm of ampulla of Vater Health Condition 5: C253- Malignant neoplasm of pancreatic duct Health Condition 6: C250- Malignant neoplasm of head of pancreas

Interventions

Intervention1: Use of ePTFE for Pancreaticojejunostomy: Firstly, the resection part of Pancreatoduodenectomy will be performed as per the inclusion criteria. Following this, a duct-to-mucosa pancreati

Sponsors

Pavithran T
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing Pancreatoduodenectomy with duct-to-mucosa Pancreaticojejunostomy 2. Benign or Malignant etiologies 3. More than or equal to 18 years of age

Exclusion criteria

Exclusion criteria: 1. Dunking type of pancreaticojejunostomy 2. Pancreaticogastrostomy

Design outcomes

Primary

MeasureTime frame
Development of Clinically Relevant Post Operative Pancreatic Fistula (type B and C) as per the ISGPS definitionTimepoint: 1 week

Secondary

MeasureTime frame
1. Duration of stay in the intensive care unit (ICU). 2. Duration of post-operative hospital stay. 3. Reintervention 4. 30-day morbidity a. Deep/organ space infection b. Delayed gastric emptying. c. Post-pancreatomy hemorrhage. d. Other complications 5. 90 day Mortality Timepoint: 3 months

Countries

India

Contacts

Public ContactDr Peeyush Varshney

All India Institute of Medical Sciences, Jodhpur

drpeeyushvarshney@gmail.com9929069007

Outcome results

None listed

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