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

Not Applicable

Completed

• Conditions: Adenocarcinoma of Head of Pancreas; Cholangio Carcinoma; Duodenal Adenocarcinoma; Carcinoma of Ampulla of Vater
• Interventions: Procedure: Open surgery; Procedure: Laparoscopic surgery

• Registration Number: NCT02081131
• Lead Sponsor: GEM Hospital & Research Center

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-07
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Surgery	Open surgery	Patients will be randomized to Open pancreatoduodenectomy
Laparoscopic Surgery	Laparoscopic surgery	patients will be randomized to laparoscopic pancreatoduodenectomy group

Primary Outcome Measures

Name	Time	Method
Hospital Stay	discharge from hospital or death which ever earlier recorded over 100 days from date of admission

Secondary Outcome Measures

Name	Time	Method
Pathological radicality	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
Operating time	At completion of the primary surgical procedure, recorded over 48 hrs	Time calculated in minutes
Complication rate	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
Blood loss	within 24 hours of primary surgical procedure	Blood loss at surgery

Trial Locations

Locations (1)

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