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A randomised study to study the impact of reinforcement patch on pancreatic fistula after Pancreatoduodenectomy

Outcomes of Reinforcement Patch Around Pancreaticojejunostomy on Clinically Relevant Pancreatic Fistula After Pancreatoduodenectomy- A Randomised Controlled Trial - OTP Trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067014
Enrollment
58
Registered
2024-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: C241- Malignant neoplasm of ampulla of Vater Health Condition 2: C250- Malignant neoplasm of head of pancreas Health Condition 3: C240- Malignant neoplasm of extrahepaticbile duct Health Condition 4: K831- Obstruction of bile duct Health Condition 5: C253- Malignant neoplasm of pancreatic duct

Interventions

Intervention1: Application of Veriset™ patch around pancreaticojejunostomy: Firstly, the resection part of Pancreatoduodenectomy will be performed as per the inclusion criteria. Following this, a stan

Sponsors

Shaikh Muna Afroz Moizuddin
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Subjected to multivisceral resection along with Pancreatoduodenectomy 2. Dunking type of pancreaticojejunostomy or Pancreaticogastrostomy 3. Patients who received neoadjuvant therapy 4. Immunosuppressed patients

Design outcomes

Primary

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

Secondary

MeasureTime frame
Duration of intensive care unit (ICU) stay. 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) Death (irrespective of the cause).Timepoint: Perioperative Period

Countries

India

Contacts

Public ContactVaibhav Kumar Varshney

All India Institute of Medical Sciences, Jodhpur

drvarshney09@gmail.com9968223072

Outcome results

None listed

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