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

Adenocarcinoma of Head of Pancreas Clinical Trial

— PLOT  

Official title:

A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081131
• Other study ID #: PLOT
• Secondary ID: CTRI/2013/09/004
• Status: Completed
• Phase: N/A
• First received: January 30, 2014
• Last updated: September 14, 2015
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: GEM Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical 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 outcomes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Head of Pancreas
• Carcinoma
• Carcinoma of Ampulla of Vater
• Cholangio Carcinoma
• Cholangiocarcinoma
• Duodenal Adenocarcinoma

Intervention

Procedure:
• Open surgery
pancreatic head resection by open method
• Laparoscopic surgery
laparoscopic pancreatoduodenectomy

Locations

Country	Name	City	State
India	Gem Hospital & Research Centre Private Limited	Coimbatore	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
GEM Hospital & Research Center

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View Citation

Kim SC, Song KB, Jung YS, Kim YH, Park do H, 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Stay		discharge from hospital or death which ever earlier recorded over 100 days from date of admission	No
Secondary	Blood loss	Blood loss at surgery	within 24 hours of primary surgical procedure	No
Secondary	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	within 7 days of surgery	No
Secondary	Operating time	Time calculated in minutes	At completion of the primary surgical procedure, recorded over 48 hrs	No
Secondary	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	100 days from date of surgery	No