ICG Fluorescence-Guided vs Conventional approach on surgical outcomes in Pancreatic Head Resection for Chronic Pancreatitis

Effect Of Indocyanine Green Fluorescence Guided Real Time Surgery Vs Conventional Approach on Surgical Outcomes in Patients Undergoing Bile Duct and Duodenum Preserving Pancreatic Head Resection Surgery for Chronic Pancreatitis- A Randomized Controlled Trial - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107563

Enrollment

Registered

2026-04-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: K861- Other chronic pancreatitis

Interventions

Intervention1: Patients undergo Bile duct and Duodenum preserving pancreatic head resection with intraoperative indocyanine green (ICG) fluorescence for real-time cholangiography to identify the bile

bile duct and perfusion are assessed by conventional anatomical dissection and visual cu

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients with chronic pancreatiitis requiring surgical management

Exclusion criteria

Exclusion criteria: 1. Patients with Chronic Pancreatitis with suspicion of malignancy 2. Previous pancreatic surgeries 3. Portal hypertension with varices or major vascular thrombosis. 4. Severe hepatic or renal impairment eGFR less than 30 mL/min/1.73m ). 5. Patients with Chronic Pancreatitis with distal biliary stricture 6. Patients with Chronic Pancreatitis who many require additional surgical procedures (Cystojejunostomy, Distal pancreatectomy, Splenectomy) 7. Known allergy to ICG or iodides. 8. Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
To determine whether using indocyanine green (ICG) fluorescence during surgery lowers the risk of bile duct-related complications in patients undergoing bile duct and duodenum-preserving pancreatic head resection (DPPHR), such as intraoperative injury, postoperative bile leak, or stricture within 90 daysTimepoint: To determine whether using indocyanine green (ICG) fluorescence during surgery lowers the risk of bile duct-related complications in patients undergoing bile duct and duodenum-preserving pancreatic head resection (DPPHR), such as intraoperative injury, postoperative bile leak, or stricture within 90 days	—

Measure

Time frame

To determine whether using indocyanine green (ICG) fluorescence during surgery lowers the risk of bile duct-related complications in patients undergoing bile duct and duodenum-preserving pancreatic head resection (DPPHR), such as intraoperative injury, postoperative bile leak, or stricture within 90 daysTimepoint: To determine whether using indocyanine green (ICG) fluorescence during surgery lowers the risk of bile duct-related complications in patients undergoing bile duct and duodenum-preserving pancreatic head resection (DPPHR), such as intraoperative injury, postoperative bile leak, or stricture within 90 days

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Secondary

Measure	Time frame
To compare overall morbidity within 30 days classified by Clavien Dindo grade, length of hospital stay (days) & readmission within 30 days between the ICG & non ICG groups. To compare functional endocrine & exocrine outcomes at 90 days between the ICG & non ICG groups. To compare the adequacy of head coring at 3 months (defined as absence of more than 5 mm residual pancreatic head tissue) radiologically using CT, postoperative pain reduction using COMPAT-SF score, & quality of life using EORTC C30 global health score between the ICG & non ICG groups. To assess the proportion of patients with preserved duodenal perfusion confirmed by ICG angiography (uniform fluorescence of duodenum within 60 seconds of injection). To assess ICG-related adverse events (anaphylaxis, urticaria, hypotension, or injection-site reactions) documented perioperatively. Timepoint: Overall morbidity will be assessed within 30 days Functional endocrine & exocrine outcomes will be assessed at 90 days. Adequacy of head coring will be assessed at 90 days. Post opertaive pain reduction & quality of life will be assessed ay 90 days. Proportion of patients with preserved duodenal perfusion will be assessed as uniform fluorescence of duodenum within 60 seconds of injection ICG related adverse events will be documented perioperatively	—

Measure

Time frame

To compare overall morbidity within 30 days classified by Clavien Dindo grade, length of hospital stay (days) & readmission within 30 days between the ICG & non ICG groups. To compare functional endocrine & exocrine outcomes at 90 days between the ICG & non ICG groups. To compare the adequacy of head coring at 3 months (defined as absence of more than 5 mm residual pancreatic head tissue) radiologically using CT, postoperative pain reduction using COMPAT-SF score, & quality of life using EORTC C30 global health score between the ICG & non ICG groups. To assess the proportion of patients with preserved duodenal perfusion confirmed by ICG angiography (uniform fluorescence of duodenum within 60 seconds of injection). To assess ICG-related adverse events (anaphylaxis, urticaria, hypotension, or injection-site reactions) documented perioperatively. Timepoint: Overall morbidity will be assessed within 30 days Functional endocrine & exocrine outcomes will be assessed at 90 days. Adequacy of head coring will be assessed at 90 days. Post opertaive pain reduction & quality of life will be assessed ay 90 days. Proportion of patients with preserved duodenal perfusion will be assessed as uniform fluorescence of duodenum within 60 seconds of injection ICG related adverse events will be documented perioperatively

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Countries

India

Contacts

Public ContactDr Shanmugam D

Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry

shandsge@gmail.com9787273017

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026