The DISSECT Study: Effect of Peri-aDventItial SMA diSsECtion on Margin sTatus During Pancreaticoduodenectomy for Resectable Pancreatic Cancer

NCT04902352 | Active Not Recruiting

• 1 other identifier: RRK6941
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

There is a high rate of R1 resection following patients undergoing pancreaticoduodenectomy for pancreatic cancer. The most commonly positive margin is the SMA. Peri-adventitial dissection has been proposed as an effective method of achieving R0 margins. There is lack of standardisation of the proposed technique and no grade 1 evidence to support routine use of this technique. The goal of this randomised controlled trial is to investigate the role of routine peri-adventitial dissection on the SMA margin status.

Conditions

Pancreatic Adenocarcinoma

Keywords

pancreatic cancer; SMA dissection; Superior mesenteric artery; margin status

Outcome Measures

Primary Outcomes (1)

• SMA margin status

  Rate of R0 resection (defined as no tumour within 1mm from the SMA margin)

  Recorded at histological examination estimated 2 weeks post-operatively

Secondary Outcomes (5)

• Length of stay

  Recorded at patient discharge (monitored by research team) and analysed at an expected time frame of 2 years (study end)

• Complications

  90 days

• adjuvant treatment

  within 1 year of surgery

• Overall survival

  Analysis at 5 years from start of trial

• Disease free survival

  Analysis at 5 years from start of trial

Study Arms (2)

Periadventitial dissection

EXPERIMENTAL

For the patients randomised for peri-adventitial dissection the right side of the SMA should be completely clear from lymphoneural tissue for at least 180 degrees on right side and from "angle" of the artery to the level of inferior border of the uncinate process.

Procedure: Periadventitial dissection of the SMA

NO periadventitial dissection

ACTIVE COMPARATOR

For patients randomised to NO peri-adventitial dissection, the lymphoneural tissue around the SMA should be left intact

Procedure: No Periadventitial dissection of the SMA

Interventions

No Periadventitial dissection of the SMA PROCEDURE

lymphoneural tissue around SMA left intact

NO periadventitial dissection

Periadventitial dissection of the SMA PROCEDURE

For the patients randomised for peri-adventitial dissection the right side of the SMA should be completely clear from lymphoneural tissue for at least 180 degrees on right side and from "angle" of the artery to the level of inferior border of the uncinate process. In the presence of an accessory or replaced right hepatic artery the peri-adventitial dissection should also be carried out around this vessel as well.

Periadventitial dissection

Eligibility Criteria

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

You may qualify if:

• All adult (≥ 18 years old) patients with a non-metastatic (based on NCCN definition) on imaging pancreatic tumour of the head or uncinate process treated with a pancreaticoduodenectomy

You may not qualify if:

• All paediatric patients (\< 18 years old)
• Patients that cannot provide consent
• All borderline, locally advanced and metastatic pancreatic tumours on imaging (based on NCCN criteria)
• All patients with a cytological or histological diagnosis of cholangiocarcinoma, ampullary and duodenal carcinoma
• All patients with benign disease or dysplasia with no evidence of malignancy

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, County (Optional), B15 2GW, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sealed envelope system for allocation of intervention Master list held by third party, researcher and surgical team aware of intervention Intervention NOT documented in notes making clinical follow up team, investigator and outcomes assessor blind to arm allocated
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant HPB Surgeon

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 26, 2021
• Study Start: April 6, 2021
• Primary Completion (Estimated): October 6, 2026
• Study Completion (Estimated): October 6, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

GB (1)