A prospective, randomized study comparing 2 techniques of pancreatoduodenectomy in pancreatic cancer with special focus on resection margins and medium term survival outcomes
- Conditions
- Patients with resetable/ borderline resectable pancreatic head cancer with good performance status.
- Registration Number
- CTRI/2013/10/004045
- Lead Sponsor
- ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
- Brief Summary
Pancreaticoduodenectomy (PD) is the only curative treatment option in pancreatic cancer and periampullary tumors. At present, tumour infiltration of the superior mesenteric artery (SMA) is considered a contraindication for PD. In *standard* PD, the invasion of SMA can usually be identified only after the neck of the pancreas has already been divided, an irrevocable step in PD. Recently a technique of early SMA dissection has been described, which allows better assessment of involvement of vascular structures (SMA/SMV/PV) early in the course of dissection and prior to irreversible step being taken. It also has the advantage of early identification and preservation of a replaced/accessory right hepatic artery originating from the SMA. xml:namespace prefix = "o" ns = "urn:schemas-microsoft-com:office:office" /
A microscopic positive margin is an important predictor of long term survival for periampullary cancers following PD. The most commonly involved is the SMA/retroperitoneal margin. Another argument in favour of the ‘SMA- first’ dissection is that it allows for dissection directly on the right medial aspect of the SMA and might decrease the rate of involved margins, making the procedure oncologically better. The lack of a standardized pathological work-up has been cited as the reason for the variation in R1 resection rates (below 20% to over 75%) reported in the literature. Verbeke *et al.* from Leeds reported an R1 resection rate of 85% in patients undergoing standardized pathological work-up which included a detailed circumferential margin mapping, axial slicing and extensive sampling. R0-resection defined as a 1 mm clearance of tumour from the margin had an impressive 5-year survival rate of 50%.
Our preliminary experience with the *P-SMA first* approach for pancreaticoduodenectomy in all patients with periampullary tumors (small number of pancreatic cancer patients) showed that this technique allows a faster pancreaticoduodenectomy and decreases PV-SMV clamp times when venous resections are required and more importantly *P-SMA first* approach group had a significantly higher lymph node yield post resection(10.7 vs. 5.95; p=0.001).We hypothesize that by virtue of its surgical approach the ‘SMA–first’ technique is likely to be oncologically sound with a higher rate of R0 resection. We therefore plan to perform a prospective randomized controlled trial between *standard* PD and *Posterior ‘SMA-first’* (*P-SMA first*) approach to PD specifically in patients with pancreatic adenocarcinoma to look at the issue of circumferential resection margins (CRM) using the standardized histopathology protocol (Leed’s protocol).
If the hypothesis is proven then undoubtedly the *posterior SMA first* approach will become the standard technique for operating on patients with pancreatic adenocarcinoma to achieve higher R0 rates and better long term survival.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 150
1.Good performance status (Eastern Cooperative Oncology Group performance status 0, 1, 2) 2.Age: 18-75 years 3.Patients with a diagnosis of i)Resectable carcinoma head of pancreas ii) Resectable periampullary tumors iii)Patients with borderline resectability (for both tumor categories) will also be included in both arms.
1.Patient unwilling to consent for the study 2.Metastatic or unresectable disease 3.Patient undergoing total pancreatectomy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome Patient accrual: 1.5-2 years | Follow up: at least 6 months post resection | Prospective clinical and path data collection | Interim analysis at 2 years 1.R0 resection rate in the 2 arms (LEEDS Protocol). Patient accrual: 1.5-2 years | Follow up: at least 6 months post resection | Prospective clinical and path data collection | Interim analysis at 2 years 2. Number of lymph nodes harvested. Patient accrual: 1.5-2 years | Follow up: at least 6 months post resection | Prospective clinical and path data collection | Interim analysis at 2 years
- Secondary Outcome Measures
Name Time Method 1.Operative time 2.Incidence of postoperative complications.
Trial Locations
- Locations (1)
Department of GI Surgery AIIMS
🇮🇳South, DELHI, India
Department of GI Surgery AIIMS🇮🇳South, DELHI, IndiaDr Sujoy PalPrincipal investigatorsujoypal@hotmail.com