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

Overview

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.

Full Title of Study: “A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2015

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

  • Procedure: Open surgery
    • pancreatic head resection by open method
  • Procedure: Laparoscopic surgery
    • laparoscopic pancreatoduodenectomy

Arms, Groups and Cohorts

  • Active Comparator: Laparoscopic Surgery
    • patients will be randomized to laparoscopic pancreatoduodenectomy group
  • Active Comparator: Open Surgery
    • Patients will be randomized to Open pancreatoduodenectomy

Clinical Trial Outcome Measures

Primary Measures

  • Hospital Stay
    • Time Frame: discharge from hospital or death which ever earlier recorded over 100 days from date of admission

Secondary Measures

  • Blood loss
    • Time Frame: within 24 hours of primary surgical procedure
    • Blood loss at surgery
  • Pathological radicality
    • Time Frame: 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
    • Time Frame: At completion of the primary surgical procedure, recorded over 48 hrs
    • Time calculated in minutes
  • Complication rate
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GEM Hospital & Research Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Senthilnathan Palanisamy, MS, DNB, Principal Investigator, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
    • Palanivelu Chinnusamy, MS, MCh, Study Director, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
    • Sandeep Sabnis, MS, Study Director, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India

References

Asbun HJ, Stauffer JA. Laparoscopic vs open pancreaticoduodenectomy: overall outcomes and severity of complications using the Accordion Severity Grading System. J Am Coll Surg. 2012 Dec;215(6):810-9. doi: 10.1016/j.jamcollsurg.2012.08.006. Epub 2012 Sep 19.

Palanivelu C, Rajan PS, Rangarajan M, Vaithiswaran V, Senthilnathan P, Parthasarathi R, Praveen Raj P. Evolution in techniques of laparoscopic pancreaticoduodenectomy: a decade long experience from a tertiary center. J Hepatobiliary Pancreat Surg. 2009;16(6):731-40. doi: 10.1007/s00534-009-0157-8. Epub 2009 Aug 4.

Kim SC, Song KB, Jung YS, Kim YH, Park DH, Lee SS, Seo DW, Lee SK, Kim MH, Park KM, Lee YJ. Short-term clinical outcomes for 100 consecutive cases of laparoscopic pylorus-preserving pancreatoduodenectomy: improvement with surgical experience. Surg Endosc. 2013 Jan;27(1):95-103. doi: 10.1007/s00464-012-2427-9. Epub 2012 Jun 30.

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