Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)
Condition: Adenocarcinoma of Head of Pancreas; Cholangio Carcinoma; Duodenal Adenocarcinoma; Carcinoma of Ampulla of Vater
MeSH terms: Carcinoma; Adenocarcinoma; Cholangiocarcinoma
Study type: Interventional

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.
    

Intervention name(s): Open surgery; Laparoscopic surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): pancreatic head resection by open method; laparoscopic pancreatoduodenectomy
Other intervention name(s): Whipple's operation, pancreatoduodenectomy; laparoscopic pancreatoduodenectomy; whipple's operation; pylorus preserving pancreatoduodenectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: periampullary cancer; pancreatic cancer; randomized controlled trial; Whipple's operation; laparoscopy