Clinical trial NCT02081131: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: GEM Hospital & Research Center
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hospital Stay
timeFrame: discharge from hospital or death which ever earlier recorded over 100 days from date of admission
Secondary outcomes:
measure: Blood loss
timeFrame: within 24 hours of primary surgical procedure
measure: Pathological radicality
timeFrame: within 7 days of surgery
measure: Operating time
timeFrame: At completion of the primary surgical procedure, recorded over 48 hrs
measure: Complication rate
timeFrame: 100 days from date of surgery
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: Gem Hospital & Research Centre Private Limited
state: Tamil Nadu
Study officials:
affiliation: Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
name: Senthilnathan Palanisamy, MS, DNB
role: PRINCIPAL_INVESTIGATOR
affiliation: Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
name: Palanivelu Chinnusamy, MS, MCh
role: STUDY_DIRECTOR
affiliation: Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India
name: Sandeep Sabnis, MS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.