Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)

NCT02081131 | Completed DMC

• 2 other identifiers: PLOTCTRI/2013/09/004016
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Hospital Stay

  discharge from hospital or death which ever earlier recorded over 100 days from date of admission

Secondary Outcomes (4)

• Blood loss

  within 24 hours of primary surgical procedure

• Pathological radicality

  within 7 days of surgery

• Operating time

  At completion of the primary surgical procedure, recorded over 48 hrs

• Complication rate

  100 days from date of surgery

Study Arms (2)

Laparoscopic Surgery

ACTIVE COMPARATOR

patients will be randomized to laparoscopic pancreatoduodenectomy group

Procedure: Laparoscopic surgery

Open Surgery

ACTIVE COMPARATOR

Patients will be randomized to Open pancreatoduodenectomy

Procedure: Open surgery

Interventions

Open surgery PROCEDURE

pancreatic head resection by open method

Also known as: Whipple's operation, pancreatoduodenectomy

Open Surgery

Laparoscopic surgery PROCEDURE

laparoscopic pancreatoduodenectomy

Also known as: laparoscopic pancreatoduodenectomy, whipple's operation, pylorus preserving pancreatoduodenectomy

Laparoscopic Surgery

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unresectable Tumor at surgery
• Pancreatoduodenectomy for other diagnosis like cystic tumors or chronic calcific pancreatitis with head mass
• With prior Neoadjuvant treatment

Sponsors & Collaborators

• GEM Hospital & Research Center: lead

Study Sites (1)

Gem Hospital & Research Centre Private Limited

Coimbatore, Tamil Nadu, 641045, India

Location

Related Publications (4)

• 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.

  PMID: 22999327 BACKGROUND

• 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.

  PMID: 19652900 BACKGROUND

• 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.

  PMID: 22752284 BACKGROUND

• 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.

  PMID: 28895142 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Conversion to Open Surgery; Pancreaticoduodenectomy; Laparoscopy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Digestive System Surgical Procedures; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Senthilnathan Palanisamy, MS, DNB

  Gem Hospital & Research Centre Private Limited, Coimbatore, Tamil Nadu, India

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: March 7, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

IN (1)