Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT) (PLOT)
A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tamil Nadu
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Coimbatore, Tamil Nadu, India, 641045
- Gem Hospital & Research Centre Private Limited
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Adult males or females with a diagnosis of either of resectable Periampullary and pancreatic head cancers with
- No evidence of metastasis
- Radiological non-involvement of Superior Mesenteric Vein & Portal Vein
- Preserved fat planes between celiac axis, Hepatic Artery & Superior Mesenteric Artery
Exclusion Criteria:
- Unresectable Tumor at surgery
- Pancreatoduodenectomy for other diagnosis like cystic tumors or chronic calcific pancreatitis with head mass
- With prior Neoadjuvant treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Laparoscopic Surgery
patients will be randomized to laparoscopic pancreatoduodenectomy group
|
laparoscopic pancreatoduodenectomy
Other Names:
|
|
ACTIVE_COMPARATOR: Open Surgery
Patients will be randomized to Open pancreatoduodenectomy
|
pancreatic head resection by open method
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hospital Stay
Time Frame: discharge from hospital or death which ever earlier recorded over 100 days from date of admission
|
discharge from hospital or death which ever earlier recorded over 100 days from date of admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood loss
Time Frame: within 24 hours of primary surgical procedure
|
Blood loss at surgery
|
within 24 hours of primary surgical procedure
|
|
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
|
within 7 days of surgery
|
|
Operating time
Time Frame: At completion of the primary surgical procedure, recorded over 48 hrs
|
Time calculated in minutes
|
At completion of the primary surgical procedure, recorded over 48 hrs
|
|
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
|
100 days from date of surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Senthilnathan Palanisamy, MS, DNB, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
- Study Director: Palanivelu Chinnusamy, MS, MCh, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
- Study Director: Sandeep Sabnis, MS, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
Publications and helpful links
General Publications
- 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.
- Palanivelu C, Senthilnathan P, Sabnis SC, Babu NS, Srivatsan Gurumurthy S, Anand Vijai N, Nalankilli VP, Praveen Raj P, Parthasarathy R, Rajapandian S. Randomized clinical trial of laparoscopic versus open pancreatoduodenectomy for periampullary tumours. Br J Surg. 2017 Oct;104(11):1443-1450. doi: 10.1002/bjs.10662.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLOT
- CTRI/2013/09/004016 (REGISTRY: Clinical Trials Registry India)
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