Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions

Conditions
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Adenocarcinoma of Head of Pancreas, Duodenal Adenocarcinoma, Carcinoma of Ampulla of Vater, Cholangio Carcinoma

Intervention / Treatment
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* Procedure: Open surgery
* Procedure: Laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males or females with a diagnosis of either of resectable Periampullary and pancreatic head cancers with No evidence of metastasis Radiological non-involvement of Superior Mesenteric Vein & Portal Vein Preserved fat planes between celiac axis, Hepatic Artery & Superior Mesenteric Artery Exclusion Criteria: Unresectable Tumor at surgery Pancreatoduodenectomy for other diagnosis like cystic tumors or chronic calcific pancreatitis with head mass With prior Neoadjuvant treatment

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Surgery<br>patients will be randomized to laparoscopic pancreatoduodenectomy group | Procedure: Laparoscopic surgery<br>* laparoscopic pancreatoduodenectomy<br>* Other names: pylorus preserving pancreatoduodenectomy;|
| Active Comparator: Open Surgery<br>Patients will be randomized to Open pancreatoduodenectomy | Procedure: Open surgery<br>* pancreatic head resection by open method<br>* Other names: Whipple's operation, pancreatoduodenectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Stay |  | discharge from hospital or death which ever earlier recorded over 100 days from date of admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Blood loss at surgery | within 24 hours of primary surgical procedure | 
| Pathological radicality | 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 | within 7 days of surgery | 
| Operating time | Time calculated in minutes | At completion of the primary surgical procedure, recorded over 48 hrs | 
| Complication rate | 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 | 100 days from date of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whipple's operation, laparoscopy, periampullary cancer, pancreatic cancer, randomized controlled trial