Brief Title
Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)
Official Title
A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions
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.
Study Type
Interventional
Primary Outcome
Hospital Stay
Secondary Outcome
Blood loss
Condition
Adenocarcinoma of Head of Pancreas
Intervention
Open surgery
Study Arms / Comparison Groups
Laparoscopic Surgery
Description: patients will be randomized to laparoscopic pancreatoduodenectomy group
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
64
Start Date
September 2013
Completion Date
September 2015
Primary Completion Date
September 2015
Eligibility Criteria
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
All
Ages
30 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Senthilnathan Palanisamy, MS, DNB, ,
Location Countries
India
Location Countries
India
Administrative Informations
NCT ID
NCT02081131
Organization ID
PLOT
Secondary IDs
CTRI/2013/09/004016
Responsible Party
Sponsor
Study Sponsor
GEM Hospital & Research Center
Study Sponsor
Senthilnathan Palanisamy, MS, DNB, Principal Investigator, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
Verification Date
September 2015