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

Bile Duct and Duodenum-preserving pancreatic head resection (DPPHR) is a function-preserving surgical alternative to pancreatoduodenectomy for patients with chronic pancreatitis. By preserving the duodenum and distal bile duct, DPPHR provides effective long-term pain relief while maintaining pancreatic endocrine and exocrine function and improving nutritional outcomes. Several meta-analyses and long-term studies have demonstrated that DPPHR leads to superior functional outcomes compared to pancreatoduodenectomy, including lower rates of new-onset diabetes and exocrine insufficiency. However, achieving adequate pancreatic head coring is crucial for effective pain control, while excessive resection may compromise the common bile duct (CBD) or surrounding vascular structures. Protecting the CBD and maintaining duodenal vascularity remain significant intraoperative challenges, particularly in patients with distorted anatomy due to chronic inflammatory fibrosis. Conventional techniques depend largely on the surgeon’s experience and visual assessment, which may not consistently ensure ductal safety or adequate perfusion.

Indocyanine green (ICG) fluorescence imaging is a technique that enables real-time intraoperative cholangiography and perfusion assessment. Early studies suggest that ICG-guided DPPHR may improve visualization of the bile duct, confirm adequate duodenal vascularity, and help assess the completeness of pancreatic head resection. However, existing evidence is limited, as most studies are retrospective with small sample sizes and focus mainly on technical feasibility. There is a lack of randomized controlled trials (RCTs) evaluating the effectiveness of ICG guidance in DPPHR.

To address this gap, the present study is designed as a prospective RCT comparing DPPHR performed with ICG guidance to conventional DPPHR without fluorescence imaging. The study will be conducted in the Department of Surgery and Surgical Gastroenterology at JIPMER. Patients with chronic pancreatitis planned for open bile duct and duodenum-preserving pancreatic head resection will be screened for eligibility and enrolled after informed consent. Preoperative evaluation will include demographic details, clinical examination, laboratory investigations, and imaging to assess pancreatic, biliary, and vascular anatomy.

Participants will be divided into two groups. The intervention group will undergo ICG-guided DPPHR, where intraoperative fluorescence imaging will be used for real-time identification of the bile duct and evaluation of duodenal and arterial arcade perfusion. The control group will undergo conventional DPPHR based on standard anatomical dissection and visual assessment. ICG will be administered intravenously following standardized hepatopancreatobiliary surgery protocols. A dose of 2.5 mg will be given approximately 60 minutes before incision for biliary mapping, while an additional 5 mg will be administered intraoperatively to assess arterial and duodenal perfusion using near-infrared imaging. Perfusion parameters such as time to fluorescence (Tmax) and half-rise time (T½MAX) will be recorded to evaluate vascular adequacy.

Fluorescence imaging will be performed at three standardized intraoperative stages: before pancreatic head coring for biliary mapping, after coring to assess arterial arcade perfusion, and before closure to detect bile leaks or compromised vascularity. Intraoperative data collected will include operative time, blood loss, transfusion requirements, complications, and ICG dosing. Postoperative monitoring will follow enhanced recovery after surgery (ERAS) protocols, with assessment of complications such as cholangitis, obstructive jaundice, bile leak, bile duct stricture, pancreatic fistula, intra-abdominal collections, and delayed gastric emptying according to established international criteria.

The primary outcome of the study will be the incidence of bile duct injury or postoperative bile leak within 90 days. Secondary outcomes will include accuracy of biliary identification, adequacy of duodenal perfusion, operative parameters, postoperative morbidity, hospital stay, and reintervention rates. Fluorescence recordings will be independently evaluated by to assess signal strength, completeness, and homogeneity.