Adenocarcinoma of Head of Pancreas Clinical Trial
Official title:
A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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