Adenocarcinoma of Head of PancreasPLOTNCT02081131
Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)
A study testing Open surgery and Laparoscopic surgery in people with Adenocarcinoma of Head of Pancreas and Cholangio Carcinoma, run by GEM Hospital & Research Center at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Adenocarcinoma of Head of Pancreas, Cholangio Carcinoma, Duodenal Adenocarcinoma
- What is being tested?
- Open surgery and Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unresectable Tumor at surgery
- Pancreatoduodenectomy for other diagnosis like cystic tumors or chronic calcific pancreatitis with head mass
- With prior Neoadjuvant treatment
Trial locations and contacts
1 site in 1 country.
India1 site
Gem Hospital & Research Centre Private Limited
Coimbatore, Tamil Nadu, 641045
About this study
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.
Read the 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.
- Conditions
- Adenocarcinoma of Head of Pancreas, Cholangio Carcinoma, Duodenal Adenocarcinoma, Carcinoma of Ampulla of Vater
- Being tested
- Open surgery, Laparoscopic surgery
- Keywords
- periampullary cancer, pancreatic cancer, randomized controlled trial, Whipple's operation, laparoscopy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open surgeryProcedure or surgery
Also called Whipple's operation, pancreatoduodenectomy
pancreatic head resection by open method
Laparoscopic surgeryProcedure or surgery
Also called laparoscopic pancreatoduodenectomy, whipple's operation, pylorus preserving pancreatoduodenectomy
laparoscopic pancreatoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Surgery | Active comparator | patients will be randomized to laparoscopic pancreatoduodenectomy group Receives: Procedure: Laparoscopic surgery |
| Open Surgery | Active comparator | Patients will be randomized to Open pancreatoduodenectomy Receives: Procedure: Open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Stay
Measured: discharge from hospital or death which ever earlier recorded over 100 days from date of admission
Secondary outcomes (4)
Blood loss
Blood loss at surgery
Measured: within 24 hours of primary surgical procedure
Pathological radicality
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
Measured: within 7 days of surgery
Operating time
Time calculated in minutes
Measured: At completion of the primary surgical procedure, recorded over 48 hrs
Complication rate
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
Measured: 100 days from date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of Head of PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- GEM Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Senthilnathan Palanisamy, MS, DNB, Principal investigator, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, IndiaPalanivelu Chinnusamy, MS, MCh, Study director, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, IndiaSandeep Sabnis, MS, Study director, Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081131
- Sponsor's protocol ID
- PLOT
- Other IDs
- CTRI/2013/09/004016
- Acronym
- PLOT
- Status last verified
- Sep 2015
- First submitted
- 30 Jan 2014
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22999327Palanivelu 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.
PubMed 19652900Kim 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.
PubMed 22752284Palanivelu 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.
PubMed 28895142
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions
- ClinicalTrials.gov ID
- NCT02081131
- Acronym / sponsor ID
- PLOT / PLOT
- Conditions
- Adenocarcinoma of Head of Pancreas, Cholangio Carcinoma, Duodenal Adenocarcinoma, Carcinoma of Ampulla of Vater
- Keywords
- periampullary cancer, pancreatic cancer, randomized controlled trial, Whipple's operation, laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- GEM Hospital & Research CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Surgery | Active comparator | Procedure: Laparoscopic surgerypatients will be randomized to laparoscopic pancreatoduodenectomy group |
| Open Surgery | Active comparator | Procedure: Open surgeryPatients will be randomized to Open pancreatoduodenectomy |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult males or females with a diagnosis of either of resectable Periampullary and pancreatic head cancers with
Key exclusion criteria (3 listed)
- Unresectable Tumor at surgery
- Pancreatoduodenectomy for other diagnosis like cystic tumors or chronic calcific pancreatitis with head mass
- With prior Neoadjuvant treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open surgeryAlso: Whipple's operation, pancreatoduodenectomypancreatic head resection by open method | Procedure or surgery | Open Surgery |
| Laparoscopic surgeryAlso: laparoscopic pancreatoduodenectomy, whipple's operation, pylorus preserving pancreatoduodenectomylaparoscopic pancreatoduodenectomy | Procedure or surgery | Laparoscopic Surgery |
Primary outcome
Hospital Stay
Time frame: discharge from hospital or death which ever earlier recorded over 100 days from date of admission
4 secondary outcomes
Blood loss
Time frame: within 24 hours of primary surgical procedure
Pathological radicality
Time frame: within 7 days of surgery
Operating time
Time frame: At completion of the primary surgical procedure, recorded over 48 hrs
Complication rate
Time frame: 100 days from date of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
- Background: PubMed 22999327Asbun 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.
- Background: PubMed 19652900Palanivelu 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.
- Background: PubMed 22752284Kim 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.
- Derived from this study: PubMed 28895142Palanivelu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senthilnathan Palanisamy, MS, DNB principal investigator
Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
Palanivelu Chinnusamy, MS, MCh study director
Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
Sandeep Sabnis, MS study director
Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open surgery and Laparoscopic surgery in people with Adenocarcinoma of Head of Pancreas and Cholangio Carcinoma, run by GEM Hospital & Research Center at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Stay (time frame: discharge from hospital or death which ever earlier recorded over 100 days from date of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02081131, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.