Adenocarcinoma of Head of Pancreas, Carcinoma of Ampulla of Vater, Cholangio Carcinoma, Duodenal Adenocarcinoma
Conditions
Keywords
periampullary cancer, pancreatic cancer, randomized controlled trial, Whipple's operation, laparoscopy
Brief summary
The aim of this study is to compare the two surgical approaches namely laparoscopic pancreatoduodenectomy and open pancreatoduodenectomy for management of periampullary and pancreatic head cancers in terms of parameters like hospital stay, pathological radicality, complication rate, peri-operative and post operative outcomes.
Detailed description
Laparoscopic pancreatoduodenectomy (LPD) although technically difficult, requiring high degree of expertise, has shown equal efficacy in terms of complications, oncological safety & overall outcome to that of open pancreatoduodenectomy (OPD) with advantages of minimally invasive surgery like decreased blood loss, reduced pain, shorter hospital stay & early return to work. Although current literature from various centres supports its use, the studies done so far are, case comparisons of either small sample of population or non-randomized trials. According to our knowledge, a randomized trial analyzing open versus laparoscopic pancreatoduodenectomy (PD) in terms of complications and outcome, has not been reported. With this current study we will try to address this issue. This study is a prospective, randomized, parallel group, controlled trail comparing laparoscopic versus open pancreatoduodenectomy in relation to the hospital stay, peri-operative parameters, pathological radicality & complications. This is a single institute based trial, being conducted at GEM hospital and research center, Coimbatore, TN, India. The trial has been approved by the GEM Hospital ethical committee. Through this trial we are planning to enroll patients having resectable periampullary and pancreatic head malignant lesion at diagnosis. After full assessment, optimization, approval of hospital tumor board with informed consent, those patients selected for surgical therapy with curative intention, will be randomized using computer generated random numbers either into Laparoscopic Pancreatoduodenectomy (LPD) group or Open Pancreatoduodenectomy (OPD) group. The details of surgery, blood loss, operating time, conversion if any as well as details of postoperative events, hospital stay & complications if any will be recorded in proforma. Protocols for adjuvant therapy according to pathological stages will be followed. These patients will be reviewed at 1, 3 and 6 months post-surgery. The primary outcome will be hospital stay at time of discharge or death. The secondary outcomes will be Blood Loss, Operating Time, Complications and pathological radicality at discharge or death. The trial is expected to last for a duration of 2 years.
Interventions
PROCEDUREOpen surgery
pancreatic head resection by open method
PROCEDURELaparoscopic surgery
laparoscopic pancreatoduodenectomy
Sponsors
GEM Hospital & Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult males or females with a diagnosis of either of resectable Periampullary and pancreatic head cancers with 1. No evidence of metastasis 2. Radiological non-involvement of Superior Mesenteric Vein & Portal Vein 3. Preserved fat planes between celiac axis, Hepatic Artery & Superior Mesenteric Artery
Exclusion criteria
1. Unresectable Tumor at surgery 2. Pancreatoduodenectomy for other diagnosis like cystic tumors or chronic calcific pancreatitis with head mass 3. With prior Neoadjuvant treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital Stay | discharge from hospital or death which ever earlier recorded over 100 days from date of admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | 100 days from date of surgery | Pancreatic surgery specific complications will be accessed by International Study group for pancreatic surgery ( ISGPS) classification like post operative pancreatic fistula ( POPF). Other complications will be accessed by Clavien Dindo Classification system |
| Blood loss | within 24 hours of primary surgical procedure | Blood loss at surgery |
| Pathological radicality | within 7 days of surgery | Two specimen arms will be compared on the basis of extent of pathological clearance like margin positivity rate, number of lymph nodes, average length of surgical margin |
| Operating time | At completion of the primary surgical procedure, recorded over 48 hrs | Time calculated in minutes |
Countries
India
Outcome results
None listed