Ignite Creation Date:
2024-05-06 @ 2:36 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02081131
Status:
COMPLETED
Last Update Posted:
2015-09-15
First Post:
2014-01-30
Brief Title:
Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial PLOT
Sponsor:
GEM Hospital Research Center
Organization:
GEM Hospital Research Center
Study Overview
Official Title:
A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLOT
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTRI201309004016 | REGISTRY | Clinical Trials Registry India | None |